Notizia - Recent Pharma, Healthcare and Biotech Happenings
Sep 25, 2025
Table of Contents
On September 19, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial neuromodulation (ITNM) therapy was inserted near the ankle and designed to treat urge urinary incontinence.
Bladder control problems affect an estimated 43 million, or one in six, U.S. adults. Of those, nearly 16 million people suffered from urge urinary incontinence, a common symptom of overactive bladder (OAB) characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom. However, only a quarter of people with general bladder control issues had ever discussed their symptoms with a doctor. These conditions had negatively impacted quality of life, mental health, and sleep, while also posing a significant economic burden on both society and patients.
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“The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” said Dr. Kevin Benson, Urogynecologist at Sanford Health and investigator for the Altaviva device pivotal study (TITAN 2). “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
“It’s an honor to bring the Altaviva device to market,” said Emily Elswick, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. “For too long, society has told people it is normal to eventually lose bladder control. We say, “Enough”. What is common does not mean it is normal. The Altaviva device is designed to provide a simple and effective experience to treat urge urinary incontinence, empowering patients with a technology that supports them in their daily lives and opens the door to renewed hope and improved quality of life.”
Patients who received an Altaviva device had returned home with therapy already activated, a first among implantable tibial devices for urge urinary incontinence. The device was inserted near the ankle during a minimally invasive procedure that did not require sedation or imaging. Approximately half the length of a stick of chewing gum, the Altaviva device sat slightly below the skin and above the fascia. It delivered electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.
The Altaviva device was designed to have a 15-year battery lifespan under expected therapy settings and deliver therapy automatically, requiring no daily intervention or manual adjustments from the patient. Recharging took up to 30 minutes when using the default recharging speed, eliminating the need for daily at-home charging equipment. Designed for real-life needs, the Altaviva device was MRI-compatible, providing patients with peace of mind for planned or unexpected medical imaging.
“Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads is their only option,” said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. “The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features. Medtronic has earned its position as the global leader in neuromodulation by consistently pushing the boundaries of innovation, and this FDA approval underscores our unwavering commitment to delivering therapies that truly change lives.”
For over 30 years, Medtronic’s neuromodulation devices have improved the lives of people with bladder control symptoms. With the introduction of the Altaviva device, Medtronic had become the only company with a full portfolio of neuromodulation therapies for this condition.
As per DelveInsight’s “Urinary Incontinence Devices Market Report,” the urinary incontinence devices market was valued at USD 2.8 billion in 2023, growing at a CAGR of 6.32% during the forecast period from 2024 to 2030 to reach USD 4.03 billion by 2030. The urinary incontinence devices market is experiencing significant growth due to the increasing instances of neurological disorders such as multiple sclerosis & spinal cord injuries, increasing cases of prostate cancer, and rising prevalence of benign prostatic hyperplasia, which are acting as major factors contributing to the overall growth of the urinary incontinence devices market during the forecast period from 2024 to 2030.
On September 22, 2025, Virtuoso Surgical, Inc., a Nashville-based company that developed a groundbreaking new class of robotic tools for endoscopic surgery, announced that its Virtuoso Surgical Robotic System had received FDA Breakthrough Device Designation for bladder lesion removal via en bloc excision. This achievement positioned the company at the forefront of early diagnosis and innovative bladder cancer care.
Built on a patented surgeon-controlled system utilizing needle-sized robotic arms, the device was designed to significantly enhance the precision and dexterity of minimally invasive surgical procedures performed with rigid endoscopes, a key segment of the global endoscopy market. Virtuoso addressed a critical clinical need for higher-quality specimens and improved staging of bladder lesions, most of which represented bladder cancer. Founded in 2016, the company had been led by experts in surgical robotics, urology, engineering, and AI, all working together to transform patient outcomes by enabling access to areas of the body that were previously too difficult to reach.
“Virtuoso is unlike any surgical robot available today, and our overall vision is to provide surgeons with unprecedented dexterity and control in rigid endoscopic surgery, which is a distinct set of procedures and approaches that have not yet benefited from robotics. Virtuoso is starting with the removal of bladder lesions, the first critical step in diagnosing, staging, and determining the management for cancerous lesions,” stated Virtuoso Surgical CEO and urologic surgeon Dr. Duke Herrell.
The en bloc resection technique, made possible through the Virtuoso system, preserves specimen integrity and enhances the accuracy of cancer staging, allowing for more definitive diagnoses compared to the traditional transurethral resection of bladder tumor (TURBT). Evidence from randomized studies has shown that en bloc resections, when performed manually, reduced one-year recurrence rates relative to standard TURBT. However, the manual technique had remained complex to learn and execute, limiting its broader adoption in the U.S. and abroad. With the introduction of its dual-instrument system and robotic dexterity, Virtuoso aimed to overcome these barriers and support broader clinical uptake.
The Virtuoso robotic platform had recently enabled a series of endoscopic bladder lesion excisions using advanced en bloc resection, performed by Dr. Jeremy Teoh, a globally recognized bladder cancer surgeon and researcher, at The Chinese University of Hong Kong (CUHK).
Dr. Jeremy Teoh commented, “The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique. This robotic approach has the potential to enable the widespread adoption of en bloc techniques, thereby minimizing local recurrence and providing a more definitive pathological specimen, which is crucial for guiding subsequent treatment decisions. We are extremely optimistic about what this technology means for the future of bladder cancer surgery and patient outcomes.”
The FDA Breakthrough Devices Program, under which Virtuoso’s system qualified, was intended to accelerate the development and review of innovative devices that addressed life-threatening or severely debilitating conditions. The designation provided prioritized regulatory interactions, more frequent feedback, and expedited review pathways, helping ensure faster patient access once safety and efficacy requirements were satisfied.
This recognition underscored the potential of Virtuoso’s technology to close gaps in bladder lesion removal and bladder cancer management compared with existing endoscopic approaches like TURBT. The company celebrated this milestone and prepared to pursue full FDA approval, while also collaborating with clinicians to validate the system’s advantages through ongoing trials and expanded patient access. Looking ahead, Virtuoso planned to extend its robotic technology beyond urology into additional specialties reliant on rigid endoscopic surgery, such as gynecology, pulmonology, otolaryngology, and neurosurgery.
As per DelveInsight’s “Surgical Robotic System Market Report,” the global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 22, 2025, Lunit, a provider of AI for cancer diagnostics and therapeutics, and Agilent Technologies Inc., a global leader in life sciences, diagnostics, and applied chemical markets, announced a nonexclusive collaboration to develop AI-based companion diagnostic solutions. The collaboration leveraged Lunit’s AI technology and Agilent’s expertise in tissue-based companion diagnostics to create advanced solutions aimed at addressing the growing demand for novel and complex biomarker assays in drug development.
Under the agreement, Lunit and Agilent worked together to develop advanced AI-powered companion diagnostic tools that enhanced diagnostic accuracy and improved the measurement of therapeutic efficacy. The initial efforts focused on integrating Lunit’s AI algorithms with Agilent’s state-of-the-art assays to evaluate critical biomarkers essential for the development of new pharmaceutical therapies.
The joint solutions supported pharmaceutical companies in the development of companion diagnostic (CDx) products, enhancing the precision and reliability of biomarker testing and ultimately providing patients with more tailored treatment options. The collaboration initially concentrated on co-developing AI-powered assays for use in research and clinical trials. This agreement marked a significant step forward for both companies, as they aimed to redefine the role of artificial intelligence in precision oncology and translational medicine.
According to DelveInsight’s “Companion Diagnostics Market Report,” the global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is primarily driven by an exponential rise in cancer cases worldwide. Additionally, the growth in awareness of precision medicine among the patient population, as well as the increasing focus of manufacturers on developing precision medicine, has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development activities for developing companion diagnostics for non-cancer disorders, as well as growing approvals and launches of various companion diagnostic products in the market, among other factors, are expected to augment the global market for companion diagnostics during the forecast period from 2024 to 2030.
On September 22, 2025, Building on its leadership in point-of-care diagnostic testing, QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies, expanded its QUICKVUE portfolio with the QUICKVUE Influenza + SARS Test, a CLIA-waived, 510(k)-cleared rapid immunoassay designed for professional use in physician office laboratories, urgent care centers, emergency departments, pharmacies, and decentralized hospital labs. The test was developed to provide rapid, simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample, delivering results in as fast as 10 minutes. This capability helped clinicians distinguish between COVID-19 and seasonal flu infections, which often present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
“Physician office labs and urgent care centers are on the front lines of respiratory illness diagnosis. With the QUICKVUE Influenza + SARS Test, we’re equipping healthcare providers with a reliable, affordable, and efficient tool to differentiate between COVID-19 and influenza in minutes,” said Tammi Ranalli, PhD, Senior Vice President, Molecular Diagnostics and Point of Care Business Units, QuidelOrtho. “This innovation reflects QuidelOrtho’s commitment to supporting healthcare professionals with cost-effective solutions that streamline clinical decisions and help manage seasonal surges in respiratory infections.”
The QUICKVUE Influenza + SARS Test offered a streamlined workflow with easy-to-collect nasal swabs, clear visual results, and cost-effective access for professional settings. It was designed for both CLIA-waived and moderate/high-complexity laboratory environments, making it suitable for a wide range of point-of-care applications. The launch of this test expanded QuidelOrtho’s portfolio of respiratory solutions, complementing the SOFIA™ 2 Flu + SARS Antigen FIA by providing a visually read option alongside the instrumented version, further reinforcing the company’s market leadership in point-of-care respiratory testing. The QUICKVUE Influenza + SARS Test became available in the United States through QuidelOrtho’s existing distribution channels and was not intended for in-home use.
According to DelveInsight’s “Point of Care Diagnostics Market Report”, the global point of care diagnostics market is estimated to grow at a CAGR of 6.61% during the forecast period from 2025 to 2032. The demand for point of care diagnostics is primarily being boosted by the increasing patient population suffering from various lifestyle disorders such as diabetes and cardiovascular diseases among others, the rising prevalence of infectious diseases, growing awareness regarding health and disease-free life, and innovation in product development among others, thereby contributing to the overall growth of the point of care diagnostics market during the forecast period from 2025 to 2032.
On September 23, 2025, ScreenPoint Medical announced that its Transpara® breast imaging AI solution had been selected as the technology of choice for the PRISM (Pragmatic Randomized Trial of Artificial Intelligence for Screening Mammography) Trial, a landmark randomized controlled study funded by the Patient-Centered Outcomes Research Institute (PCORI). Backed by a $16 million award, this trial represented the first large-scale effort in the United States to rigorously evaluate the role of artificial intelligence (AI) in breast cancer screening.
Led by UCLA and UC Davis, the PRISM Trial studied whether AI support could help radiologists detect breast cancer earlier, improve mammography accuracy, and reduce unnecessary patient callbacks. The trial also included focus groups and surveys to capture patient experiences and assess perceptions of AI among both clinicians and patients. The study involved hundreds of thousands of mammograms interpreted at leading academic medical centers, including UCLA, UC Davis, UC San Diego, Boston Medical Center, the University of Miami, the University of Washington/Fred Hutchinson Cancer Center, and the University of Wisconsin–Madison. ScreenPoint Medical’s Transpara Detection software was used as part of the study protocol, with clinical workflow integration provided by the Aidoc aiOS platform.
“This landmark trial attests to three pillars: the pioneering vision of the researchers involved, PCORI’s forward-thinking perspective on technology, and the potential of AI to help radiologists shape a healthier future,” said Pieter Kroese, Chief Executive Officer of ScreenPoint Medical. “We are honored that Transpara was selected for the PRISM Trial. We are equally proud to support academic medical centers and breast imaging facilities in advancing earlier breast cancer detection as well as more patient-centered and personalized systems of care.”
With a proven prospective track record in breast imaging AI research, Transpara Breast AI has already been used across imaging service lines, academic institutions, and screening programs worldwide, analyzing over 10 million mammograms to date. The technology had been trusted by radiologists and patients alike to enhance accuracy, improve consistency, and maximize efficiency, while ensuring physicians remained central to every clinical decision.
According to DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging Market Report”, the global AI in medical imaging market size was estimated at USD 1.36 billion in 2023 and is projected to reach USD 19.78 billion by 2033, growing at a CAGR of 34.67% from 2024 to 2030. Several key factors have driven the market for Artificial Intelligence (AI) in Medical Imaging. The increasing demand for early and accurate disease diagnosis has fueled the adoption of AI-powered imaging solutions, as they enable radiologists to detect abnormalities more quickly and with higher precision. The growing prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions has further accelerated the need for advanced imaging analysis. Additionally, shortages of skilled radiologists worldwide, combined with the push for workflow efficiency in healthcare facilities, have highlighted the value of AI in automating routine tasks and reducing diagnostic errors. Technological advancements in deep learning and computer vision, along with the increasing integration of AI into hospital IT systems and PACS (Picture Archiving and Communication Systems), have also contributed to market growth. Furthermore, rising investments from public and private sectors, regulatory support for AI-enabled medical devices, and the expansion of healthcare infrastructure in developing regions have collectively strengthened the AI medical imaging market.
On September 22, 2025, IceCure Medical Ltd., a developer of minimally invasive cryoablation technology, participated in the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting held from September 13-17, 2025, in Barcelona, Spain. The company showcased its ProSense® single-cryoprobe liquid nitrogen cryoablation system to a large number of medical practitioners through live demonstrations, highlighting its applications in interventional oncology, particularly for breast cancer patients.
During the meeting, three hands-on device training sessions were conducted, and an honorary lecture by Dr. Franco Orsi from the European Institute of Oncology discussed the evolution of breast cancer treatment and emphasized the use of ProSense® in the PRECICE trial, which treated 234 Luminal A and B patients over 50 years of age with early-stage breast cancer. The trial, sponsored by the Italian Ministry of Health, aimed to expand the population studied beyond IceCure’s ICE3 study.
Additionally, three presentations focused on breast cancer treatment using cryoablation. Dr. Sofia Baldi Giorgi presented findings showing that combining cryoablation with hormonal therapy significantly reduced tumor size and residual disease in patients ineligible for surgery. Dr. Toulsie Ramthohul reported on a prospective study of 55 elderly patients with small HR+/HER2- breast cancers, demonstrating that cryoablation was a safe and effective alternative to surgery. Dr. Francesca Pugliese evaluated cryoablation across different breast tumor subtypes, confirming its safety and effectiveness as an option for low-grade, unifocal invasive ductal carcinoma.
“We had a very successful participation at CIRSE this year, as ProSense® offers what we believe is the most advanced clinically proven LN2 cryoablation system to the growing number of interventional radiologists looking to grow their practice in breast care,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “As always, we truly appreciate the medical doctors who have conducted their own investigator-initiated studies of ProSense® and who continue to actively share their findings and positive experiences with their colleagues at these important medical conferences.”
The meeting also included a presentation by Prof. Julien Frandon from Nîmes University Hospital on the use of ProSense® for abdominal wall endometriosis (AWE). The study demonstrated that single-probe liquid nitrogen cryoablation significantly reduced pain scores and achieved necrotic changes in 95% of cases while preserving aesthetic outcomes, offering a minimally invasive alternative to surgery for AWE patients.
According to DelveInsight’s “Cryoablation Devices Market Report”, the global cryoablation devices market is estimated to advance at a CAGR of 8.8% during the forecast period from 2024 to 2030. The demand for cryoablation devices is primarily being boosted by the rising number of patients suffering from cardiovascular disorders, the increase in the number of patients suffering from chronic disorders such as cancer, the higher availability of customized probes for cryoablation, the increasing technological advancements associated with the cryoablation devices will help in contributing in the overall market growth of the cryoablation devices during the forecast period from 2024-2030.
Article in PDF
Sep 25, 2025
Table of Contents
On September 19, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial neuromodulation (ITNM) therapy was inserted near the ankle and designed to treat urge urinary incontinence.
Bladder control problems affect an estimated 43 million, or one in six, U.S. adults. Of those, nearly 16 million people suffered from urge urinary incontinence, a common symptom of overactive bladder (OAB) characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom. However, only a quarter of people with general bladder control issues had ever discussed their symptoms with a doctor. These conditions had negatively impacted quality of life, mental health, and sleep, while also posing a significant economic burden on both society and patients.
“The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” said Dr. Kevin Benson, Urogynecologist at Sanford Health and investigator for the Altaviva device pivotal study (TITAN 2). “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
“It’s an honor to bring the Altaviva device to market,” said Emily Elswick, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. “For too long, society has told people it is normal to eventually lose bladder control. We say, “Enough”. What is common does not mean it is normal. The Altaviva device is designed to provide a simple and effective experience to treat urge urinary incontinence, empowering patients with a technology that supports them in their daily lives and opens the door to renewed hope and improved quality of life.”
Patients who received an Altaviva device had returned home with therapy already activated, a first among implantable tibial devices for urge urinary incontinence. The device was inserted near the ankle during a minimally invasive procedure that did not require sedation or imaging. Approximately half the length of a stick of chewing gum, the Altaviva device sat slightly below the skin and above the fascia. It delivered electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.
The Altaviva device was designed to have a 15-year battery lifespan under expected therapy settings and deliver therapy automatically, requiring no daily intervention or manual adjustments from the patient. Recharging took up to 30 minutes when using the default recharging speed, eliminating the need for daily at-home charging equipment. Designed for real-life needs, the Altaviva device was MRI-compatible, providing patients with peace of mind for planned or unexpected medical imaging.
“Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads is their only option,” said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. “The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features. Medtronic has earned its position as the global leader in neuromodulation by consistently pushing the boundaries of innovation, and this FDA approval underscores our unwavering commitment to delivering therapies that truly change lives.”
For over 30 years, Medtronic’s neuromodulation devices have improved the lives of people with bladder control symptoms. With the introduction of the Altaviva device, Medtronic had become the only company with a full portfolio of neuromodulation therapies for this condition.
As per DelveInsight’s “Urinary Incontinence Devices Market Report,” the urinary incontinence devices market was valued at USD 2.8 billion in 2023, growing at a CAGR of 6.32% during the forecast period from 2024 to 2030 to reach USD 4.03 billion by 2030. The urinary incontinence devices market is experiencing significant growth due to the increasing instances of neurological disorders such as multiple sclerosis & spinal cord injuries, increasing cases of prostate cancer, and rising prevalence of benign prostatic hyperplasia, which are acting as major factors contributing to the overall growth of the urinary incontinence devices market during the forecast period from 2024 to 2030.
On September 22, 2025, Virtuoso Surgical, Inc., a Nashville-based company that developed a groundbreaking new class of robotic tools for endoscopic surgery, announced that its Virtuoso Surgical Robotic System had received FDA Breakthrough Device Designation for bladder lesion removal via en bloc excision. This achievement positioned the company at the forefront of early diagnosis and innovative bladder cancer care.
Built on a patented surgeon-controlled system utilizing needle-sized robotic arms, the device was designed to significantly enhance the precision and dexterity of minimally invasive surgical procedures performed with rigid endoscopes, a key segment of the global endoscopy market. Virtuoso addressed a critical clinical need for higher-quality specimens and improved staging of bladder lesions, most of which represented bladder cancer. Founded in 2016, the company had been led by experts in surgical robotics, urology, engineering, and AI, all working together to transform patient outcomes by enabling access to areas of the body that were previously too difficult to reach.
“Virtuoso is unlike any surgical robot available today, and our overall vision is to provide surgeons with unprecedented dexterity and control in rigid endoscopic surgery, which is a distinct set of procedures and approaches that have not yet benefited from robotics. Virtuoso is starting with the removal of bladder lesions, the first critical step in diagnosing, staging, and determining the management for cancerous lesions,” stated Virtuoso Surgical CEO and urologic surgeon Dr. Duke Herrell.
The en bloc resection technique, made possible through the Virtuoso system, preserves specimen integrity and enhances the accuracy of cancer staging, allowing for more definitive diagnoses compared to the traditional transurethral resection of bladder tumor (TURBT). Evidence from randomized studies has shown that en bloc resections, when performed manually, reduced one-year recurrence rates relative to standard TURBT. However, the manual technique had remained complex to learn and execute, limiting its broader adoption in the U.S. and abroad. With the introduction of its dual-instrument system and robotic dexterity, Virtuoso aimed to overcome these barriers and support broader clinical uptake.
The Virtuoso robotic platform had recently enabled a series of endoscopic bladder lesion excisions using advanced en bloc resection, performed by Dr. Jeremy Teoh, a globally recognized bladder cancer surgeon and researcher, at The Chinese University of Hong Kong (CUHK).
Dr. Jeremy Teoh commented, “The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique. This robotic approach has the potential to enable the widespread adoption of en bloc techniques, thereby minimizing local recurrence and providing a more definitive pathological specimen, which is crucial for guiding subsequent treatment decisions. We are extremely optimistic about what this technology means for the future of bladder cancer surgery and patient outcomes.”
The FDA Breakthrough Devices Program, under which Virtuoso’s system qualified, was intended to accelerate the development and review of innovative devices that addressed life-threatening or severely debilitating conditions. The designation provided prioritized regulatory interactions, more frequent feedback, and expedited review pathways, helping ensure faster patient access once safety and efficacy requirements were satisfied.
This recognition underscored the potential of Virtuoso’s technology to close gaps in bladder lesion removal and bladder cancer management compared with existing endoscopic approaches like TURBT. The company celebrated this milestone and prepared to pursue full FDA approval, while also collaborating with clinicians to validate the system’s advantages through ongoing trials and expanded patient access. Looking ahead, Virtuoso planned to extend its robotic technology beyond urology into additional specialties reliant on rigid endoscopic surgery, such as gynecology, pulmonology, otolaryngology, and neurosurgery.
As per DelveInsight’s “Surgical Robotic System Market Report,” the global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 22, 2025, Lunit, a provider of AI for cancer diagnostics and therapeutics, and Agilent Technologies Inc., a global leader in life sciences, diagnostics, and applied chemical markets, announced a nonexclusive collaboration to develop AI-based companion diagnostic solutions. The collaboration leveraged Lunit’s AI technology and Agilent’s expertise in tissue-based companion diagnostics to create advanced solutions aimed at addressing the growing demand for novel and complex biomarker assays in drug development.
Under the agreement, Lunit and Agilent worked together to develop advanced AI-powered companion diagnostic tools that enhanced diagnostic accuracy and improved the measurement of therapeutic efficacy. The initial efforts focused on integrating Lunit’s AI algorithms with Agilent’s state-of-the-art assays to evaluate critical biomarkers essential for the development of new pharmaceutical therapies.
The joint solutions supported pharmaceutical companies in the development of companion diagnostic (CDx) products, enhancing the precision and reliability of biomarker testing and ultimately providing patients with more tailored treatment options. The collaboration initially concentrated on co-developing AI-powered assays for use in research and clinical trials. This agreement marked a significant step forward for both companies, as they aimed to redefine the role of artificial intelligence in precision oncology and translational medicine.
According to DelveInsight’s “Companion Diagnostics Market Report,” the global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is primarily driven by an exponential rise in cancer cases worldwide. Additionally, the growth in awareness of precision medicine among the patient population, as well as the increasing focus of manufacturers on developing precision medicine, has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development activities for developing companion diagnostics for non-cancer disorders, as well as growing approvals and launches of various companion diagnostic products in the market, among other factors, are expected to augment the global market for companion diagnostics during the forecast period from 2024 to 2030.
On September 22, 2025, Building on its leadership in point-of-care diagnostic testing, QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies, expanded its QUICKVUE portfolio with the QUICKVUE Influenza + SARS Test, a CLIA-waived, 510(k)-cleared rapid immunoassay designed for professional use in physician office laboratories, urgent care centers, emergency departments, pharmacies, and decentralized hospital labs. The test was developed to provide rapid, simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample, delivering results in as fast as 10 minutes. This capability helped clinicians distinguish between COVID-19 and seasonal flu infections, which often present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
“Physician office labs and urgent care centers are on the front lines of respiratory illness diagnosis. With the QUICKVUE Influenza + SARS Test, we’re equipping healthcare providers with a reliable, affordable, and efficient tool to differentiate between COVID-19 and influenza in minutes,” said Tammi Ranalli, PhD, Senior Vice President, Molecular Diagnostics and Point of Care Business Units, QuidelOrtho. “This innovation reflects QuidelOrtho’s commitment to supporting healthcare professionals with cost-effective solutions that streamline clinical decisions and help manage seasonal surges in respiratory infections.”
The QUICKVUE Influenza + SARS Test offered a streamlined workflow with easy-to-collect nasal swabs, clear visual results, and cost-effective access for professional settings. It was designed for both CLIA-waived and moderate/high-complexity laboratory environments, making it suitable for a wide range of point-of-care applications. The launch of this test expanded QuidelOrtho’s portfolio of respiratory solutions, complementing the SOFIA™ 2 Flu + SARS Antigen FIA by providing a visually read option alongside the instrumented version, further reinforcing the company’s market leadership in point-of-care respiratory testing. The QUICKVUE Influenza + SARS Test became available in the United States through QuidelOrtho’s existing distribution channels and was not intended for in-home use.
According to DelveInsight’s “Point of Care Diagnostics Market Report”, the global point of care diagnostics market is estimated to grow at a CAGR of 6.61% during the forecast period from 2025 to 2032. The demand for point of care diagnostics is primarily being boosted by the increasing patient population suffering from various lifestyle disorders such as diabetes and cardiovascular diseases among others, the rising prevalence of infectious diseases, growing awareness regarding health and disease-free life, and innovation in product development among others, thereby contributing to the overall growth of the point of care diagnostics market during the forecast period from 2025 to 2032.
On September 23, 2025, ScreenPoint Medical announced that its Transpara® breast imaging AI solution had been selected as the technology of choice for the PRISM (Pragmatic Randomized Trial of Artificial Intelligence for Screening Mammography) Trial, a landmark randomized controlled study funded by the Patient-Centered Outcomes Research Institute (PCORI). Backed by a $16 million award, this trial represented the first large-scale effort in the United States to rigorously evaluate the role of artificial intelligence (AI) in breast cancer screening.
Led by UCLA and UC Davis, the PRISM Trial studied whether AI support could help radiologists detect breast cancer earlier, improve mammography accuracy, and reduce unnecessary patient callbacks. The trial also included focus groups and surveys to capture patient experiences and assess perceptions of AI among both clinicians and patients. The study involved hundreds of thousands of mammograms interpreted at leading academic medical centers, including UCLA, UC Davis, UC San Diego, Boston Medical Center, the University of Miami, the University of Washington/Fred Hutchinson Cancer Center, and the University of Wisconsin–Madison. ScreenPoint Medical’s Transpara Detection software was used as part of the study protocol, with clinical workflow integration provided by the Aidoc aiOS platform.
“This landmark trial attests to three pillars: the pioneering vision of the researchers involved, PCORI’s forward-thinking perspective on technology, and the potential of AI to help radiologists shape a healthier future,” said Pieter Kroese, Chief Executive Officer of ScreenPoint Medical. “We are honored that Transpara was selected for the PRISM Trial. We are equally proud to support academic medical centers and breast imaging facilities in advancing earlier breast cancer detection as well as more patient-centered and personalized systems of care.”
With a proven prospective track record in breast imaging AI research, Transpara Breast AI has already been used across imaging service lines, academic institutions, and screening programs worldwide, analyzing over 10 million mammograms to date. The technology had been trusted by radiologists and patients alike to enhance accuracy, improve consistency, and maximize efficiency, while ensuring physicians remained central to every clinical decision.
According to DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging Market Report”, the global AI in medical imaging market size was estimated at USD 1.36 billion in 2023 and is projected to reach USD 19.78 billion by 2033, growing at a CAGR of 34.67% from 2024 to 2030. Several key factors have driven the market for Artificial Intelligence (AI) in Medical Imaging. The increasing demand for early and accurate disease diagnosis has fueled the adoption of AI-powered imaging solutions, as they enable radiologists to detect abnormalities more quickly and with higher precision. The growing prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions has further accelerated the need for advanced imaging analysis. Additionally, shortages of skilled radiologists worldwide, combined with the push for workflow efficiency in healthcare facilities, have highlighted the value of AI in automating routine tasks and reducing diagnostic errors. Technological advancements in deep learning and computer vision, along with the increasing integration of AI into hospital IT systems and PACS (Picture Archiving and Communication Systems), have also contributed to market growth. Furthermore, rising investments from public and private sectors, regulatory support for AI-enabled medical devices, and the expansion of healthcare infrastructure in developing regions have collectively strengthened the AI medical imaging market.
On September 22, 2025, IceCure Medical Ltd., a developer of minimally invasive cryoablation technology, participated in the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting held from September 13-17, 2025, in Barcelona, Spain. The company showcased its ProSense® single-cryoprobe liquid nitrogen cryoablation system to a large number of medical practitioners through live demonstrations, highlighting its applications in interventional oncology, particularly for breast cancer patients.
During the meeting, three hands-on device training sessions were conducted, and an honorary lecture by Dr. Franco Orsi from the European Institute of Oncology discussed the evolution of breast cancer treatment and emphasized the use of ProSense® in the PRECICE trial, which treated 234 Luminal A and B patients over 50 years of age with early-stage breast cancer. The trial, sponsored by the Italian Ministry of Health, aimed to expand the population studied beyond IceCure’s ICE3 study.
Additionally, three presentations focused on breast cancer treatment using cryoablation. Dr. Sofia Baldi Giorgi presented findings showing that combining cryoablation with hormonal therapy significantly reduced tumor size and residual disease in patients ineligible for surgery. Dr. Toulsie Ramthohul reported on a prospective study of 55 elderly patients with small HR+/HER2- breast cancers, demonstrating that cryoablation was a safe and effective alternative to surgery. Dr. Francesca Pugliese evaluated cryoablation across different breast tumor subtypes, confirming its safety and effectiveness as an option for low-grade, unifocal invasive ductal carcinoma.
“We had a very successful participation at CIRSE this year, as ProSense® offers what we believe is the most advanced clinically proven LN2 cryoablation system to the growing number of interventional radiologists looking to grow their practice in breast care,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “As always, we truly appreciate the medical doctors who have conducted their own investigator-initiated studies of ProSense® and who continue to actively share their findings and positive experiences with their colleagues at these important medical conferences.”
The meeting also included a presentation by Prof. Julien Frandon from Nîmes University Hospital on the use of ProSense® for abdominal wall endometriosis (AWE). The study demonstrated that single-probe liquid nitrogen cryoablation significantly reduced pain scores and achieved necrotic changes in 95% of cases while preserving aesthetic outcomes, offering a minimally invasive alternative to surgery for AWE patients.
According to DelveInsight’s “Cryoablation Devices Market Report”, the global cryoablation devices market is estimated to advance at a CAGR of 8.8% during the forecast period from 2024 to 2030. The demand for cryoablation devices is primarily being boosted by the rising number of patients suffering from cardiovascular disorders, the increase in the number of patients suffering from chronic disorders such as cancer, the higher availability of customized probes for cryoablation, the increasing technological advancements associated with the cryoablation devices will help in contributing in the overall market growth of the cryoablation devices during the forecast period from 2024-2030.
