Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jun 19, 2025
Table of Contents
On June 12, 2025, San Mateo, California–Presidio Medical, Inc., a global clinical-stage medical device company, received Investigational New Drug (IDE) approval from the U.S. FDA to initiate its global, pivotal randomized controlled trial, the FULFILL Study, in both the United States and Australia. The study will evaluate the company’s proprietary Ultra Low Frequency (ULF™) neuromodulation platform, which delivers therapy through leads implanted in the epidural space, commonly referred to as Spinal Cord Stimulation (SCS).
Presidio Medical is focused on advancing patient-centered technologies, specifically a novel approach to treating chronic nociceptive low back pain. The ULF neuromodulation platform is engineered to alleviate localized pain by diminishing neuronal activity, potentially offering sustained relief for patients who currently lack effective treatment options. As there are no approved SCS therapies for nociceptive back pain, this represents a significant unmet need in a market estimated at $20 billion.
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Additionally, the company is pleased to welcome Dimas Jiménez as its new Chief Financial Officer (CFO). Mr. Jiménez brings more than 40 years of financial expertise, with experience ranging from Wall Street to leadership roles in both established and emerging life science companies. In his new role, he will focus on strengthening Presidio’s financial infrastructure, supporting the commercialization of the ULF neuromodulation system, and enhancing engagement with current and prospective investors.
“IDE approval from the FDA represents a significant milestone for Presidio and enables the study of ultra low frequency modulation of the nervous system. The results from our first-in-human clinical trial in Australia, which were presented by Dr. Marc Russo at NANS earlier this year, were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform,” said Michael Onuscheck, Presidio Medical’s Chief Executive Officer.
“We are extremely pleased to welcome Dimas to the Presidio team. The breadth and depth of his experience within the life science industry and his expertise in working with pre-commercialization start-up organizations is invaluable as we continue to grow and evolve as a company,” said Onuscheck.
“Presidio’s ULF platform has the potential to greatly improve the lives of patients who suffer from debilitating chronic back pain. I’ve spent a significant amount of my career working with companies whose goal is to disrupt the status quo. I couldn’t be more excited to be a part of this mission-driven and patient-centric organization,” said Jiménez.
As per DelveInsight’s “Neuromodulation Devices Market Report”, the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities, along with collaborations among key players, are significantly contributing to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
On June 11, 2025, Creo Medical announced that the U.S. Food and Drug Administration (FDA) granted clearance for our SpydrBlade™ Flex device, a major achievement for Creo, completing FDA approvals across our full portfolio of advanced energy gastrointestinal (GI) products.
SpydrBlade™ Flex is an innovative, multi-functional endoscopic tool that delivers both cutting and coagulation capabilities—features traditionally limited to laparoscopic surgery through a flexible endoscope. Designed to support a wide range of therapeutic endoscopy procedures, the device offers unmatched precision, adaptability, and versatility, equipping clinicians with a powerful solution to streamline complex interventions and drive broader clinical adoption.
Since its successful commercial debut in Europe in March 2025, SpydrBlade™ Flex has already proven its clinical utility in procedures such as Zenker’s Peroral Endoscopic Myotomy (Z-POEM), Colonic Endoscopic Submucosal Dissection (ESD), Oesophageal ESD, POEM, and F-POEM
With FDA clearance now in place, Creo is set to begin commercial rollout in the U.S., supported by its robust direct sales team and a well-established network of leading clinical experts.
Craig Gulliford, Chief Executive Officer of Creo, said: “This is a proud and pivotal moment for Creo. FDA clearance for SpydrBlade™ Flex confirms the strength and novelty of our GI product portfolio. The device has overcome significant design challenges, with unique intellectual property that sets it apart in the market.”
“Professor Robert Hawes, MD, once described SpydrBlade™ Flex as ‘the harmonic scalpel at the end of a flexible scope,’ which perfectly encapsulates our goal: bringing operating room capability into flexible endoscopy.”
“With a clear path to reimbursement and a ready-to-deploy sales infrastructure, we’re excited about bringing SpydrBlade™ Flex to clinicians and patients across the United States.”
As per DelveInsight’s “Endoscopes Market Report”, the endoscopes market was valued at USD 12.95 billion in 2023, growing at a CAGR of 6.05% during the forecast period from 2024 to 2030 to reach USD 18.32 billion by 2030. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic disease which require the use of endoscopes for diagnosis, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and crohn’s disease, increase in number of geriatric population who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2024 to 2030.
On June 16, 2025, Penumbra, Inc., a global leader in thrombectomy, announced the completion of patient enrollment in the STORM-PE clinical trial, a pivotal, prospective, multi-center randomized controlled study. The trial enrolled 100 patients to compare the effectiveness of computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash™ system combined with anticoagulation therapy, against anticoagulation therapy alone, for treating acute intermediate-high risk pulmonary embolism (PE).
Conducted in collaboration with The PERT Consortium®, a multidisciplinary organization focused on enhancing PE patient care, the study aims to generate high-quality evidence on the benefits of CAVT in improving right heart function and clinical outcomes in this critically ill population.
In the United States, approximately 900,000 cases of symptomatic PE are reported each year, with 10–30% of affected individuals dying within one month of diagnosis, underscoring the severity of the condition.
Penumbra’s Lightning Flash system represents the most advanced mechanical thrombectomy technology available for treating venous and pulmonary thrombi. Incorporating the company’s Lightning CAVT platform, it features state-of-the-art dual clot detection algorithms that utilize both pressure and flow sensing to distinguish between clot and blood flow. The system includes a MaxID hypotube-based catheter, offering a large inner diameter while maintaining a slim, flexible profile with a soft, atraumatic tip—designed to ensure efficient, safe, and streamlined clot removal, even within the body’s complex vascular anatomy.
“This is an important milestone that underscores Penumbra’s commitment to transforming care for patients with pulmonary embolism,” said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “The trial successfully randomized patients well ahead of schedule thanks to the dedication of our clinical partners and the tireless efforts of our internal teams.”
“Pulmonary embolism remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high risk patients are not well defined,” said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE and hematologist at the Massachusetts General Hospital. “The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care.”
As per DelveInsight’s “Thrombectomy Devices Market Report”, the thrombectomy devices market is poised for significant growth, projected to achieve a remarkable CAGR of 5.24% during the forecast period from 2024 to 2030. The demand for thrombectomy devices is being boosted by the increasing prevalence of lifestyle disorders such as low blood pressure, diabetes, obesity, age, and others. Further, the increasing prevalence of venous thromboembolism, cardiovascular diseases, cancer, and neurological diseases, such as ischemic stroke, hemorrhagic stroke, and peripheral diseases, among other,s will lead to the formation of blood clots, thereby leading to the increased demand for thrombectomy devices.
In addition, the increasing demand for minimally invasive approaches for treatment, lack of physical activity, rising adoption of smoking, rising device launches and approvals, surging innovations in product development, and shifting key players’ focus towards the development of technologically advanced product and initiatives to increase awareness regarding neurovascular diseases and their prevention among others are thereby contributing to the overall growth of the thrombectomy devices market during the forecast period from 2024 to 2030.
On June 17, 2025, Adona Medical, a portfolio company of Shifamed, announced the successful completion of enrollment in its ATHENS-HF first-in-human clinical study. The company is developing one of the world’s first cardiovascular implants that combines both therapeutic and diagnostic capabilities. In this study, its chronically adjustable interatrial shunt, integrated with bi-atrial pressure monitoring, was implanted in 10 heart failure patients, achieving a 100% procedural success rate. Each patient underwent successful adjustment of the shunt diameter, both increasing and decreasing from the original setting, with measurable effects observed based on the size changes.
The ATHENS-HF study included patients with both preserved and reduced ejection fraction heart failure. Most participants have now reached the 90-day follow-up milestone and, as planned, underwent additional procedures to modify the shunt size months after the initial implantation. To date, there have been no major procedural complications or site-reported major adverse cardiovascular and neurovascular events (MACNE). Adona plans to present the primary endpoint results from the study later this year.
The company’s device incorporates a uniquely adjustable flow channel, enabling more personalized treatment than traditional shunt technologies with fixed geometries. Additionally, the device includes embedded sensors that automatically collect pressure data from both atria several times daily without requiring any action from the patient. This continuous monitoring offers clinicians a more comprehensive view of a patient’s hemodynamic condition and has the potential to enhance shunt therapy by supporting more precise and proactive treatment decisions.
“A ‘one-size-fits-all’ technology may not be an optimal approach for all patients because heart failure is a diverse and evolving condition. The ideal shunting solution would enable adaptive flow rates and provide hemodynamic feedback so that the shunt device could be adjusted to optimize therapy based on the patient’s needs, similar to calibrating for optimal medical therapy,” shared Gregg W. Stone, MD, FACC, MSCAI, Mount Sinai Heart Health System and Co-Principal Investigator for the ATHENS-HF study. “The Adona interatrial shunt is designed to allow for tailored hemodynamic modulation in response to feedback from the integrated pressure sensors and the patient’s changing clinical status, offering promise to a broad patient population.”
“During the initial cases, I have seen firsthand that the Adona shunt can be safely and reliably deployed, and that the bi-atrial sensors provide important insights into the hemodynamic condition of the patient and the immediate impact of the shunting therapy,” said Gagan Singh, MD, MS, Clinical Cardiovascular Research Unit Director, University of California Davis Health, and Clinical Advisor and Proctor for ATHENS-HF. “Additionally, the early clinical experience preliminarily indicates the shunt diameter can be adjusted smaller or larger post-implantation, allowing for treatment tailored to patient-specific needs.”
According to DelveInsight’s “Tissue Heart Valves Market Report,” the tissue heart valves market is estimated to grow at a CAGR of 7.56% during the forecast period from 2024 to 2030. The demand for tissue heart valves is primarily witnessing growth on account of the high prevalence of heart valve diseases such as aortic valve degeneration and aortic stenosis, the increase in demand for minimally invasive procedures, technological advancements of the tissue heart valves, and the longer life expectancy of the geriatric population.
On June 17, 2025, Johnson & Johnson, a global leader in eye health, announced that it had expanded its portfolio of presbyopia-correcting intraocular lenses (PC-IOL) with the rollout of the TECNIS Odyssey IOL in Europe, the Middle East, and Canada. The new full visual range IOL offered high-quality and continuous vision with an unmatched range. It allowed patients to see clearly from far to near and at intermediate distances, significantly reducing their dependence on glasses. Built on the industry-leading TECNIS platform, which combined advanced optics and proprietary materials, the TECNIS Odyssey IOL delivered consistently clear, high-contrast vision.
“TECNIS Odyssey IOL is the fastest growing PC-IOL in the United States, and we are excited to be making it available to more patients around the world. It addresses a significant unmet need for cataract patients seeking greater spectacle independence. Now, together with TECNIS PureSee, TECNIS Odyssey IOL elevates the strength and depth of our global IOL portfolio, meeting the diverse needs of today’s aging population,” said Peter Menziuso, Company Group Chairman, Vision, Johnson & Johnson.
“From my early experience, what sets the TECNIS Odyssey IOL apart, is its ability to deliver consistent visual outcomes across a wide range of patients, due to its advanced design with higher tolerance to residual refractive error,” said Professor Beatrice Cochener-Lamard, Head of the Ophthalmology Department at Brest University Hospital in France.
Johnson & Johnson launched the TECNIS Odyssey IOL as its latest innovation for enhanced visual freedom, offering clear vision at all distances near, intermediate, and far with minimal reliance on glasses. Its unique diffractive surface provided continuous vision and reduced night-time disturbances like halos and glare. Clinical results showed high patient satisfaction: 94% were pleased with overall vision, 96% with smartphone reading, and 97% with distance vision. The IOL was made available in Europe, the Middle East, Canada, the U.S., Puerto Rico, and Japan. The company also expanded its TECNIS portfolio to include TECNIS PureSee IOL in APAC and Latin America, though it had not received PMA approval in the U.S.
According to DelveInsight’s “Intraocular Lens Market Report”, the global intraocular lens market was valued at USD 4,648.96 million in 2024, growing at a CAGR of 6.12% during the forecast period from 2025 to 2032 to reach USD 7,414.66 million by 2032. The intraocular lens market is being significantly boosted by the growing cases of eye-related disorders such as cataracts, presbyopia, and astigmatism, which are increasing the demand for corrective surgical interventions. This rising disease burden is complemented by improved awareness and accessibility to eye care services, especially in developing regions, enabling more patients to seek treatment. Additionally, ongoing technological advancements in lens materials and designs, such as the development of multifocal and extended depth-of-focus lenses, are enhancing visual outcomes and patient satisfaction. Furthermore, increased product development activities by key market players are leading to the introduction of innovative and customized IOL solutions, collectively accelerating the growth of the global intraocular lens market during the forecast period from 2025 to 2032.
On June 17, 2025, Royal Philips launched the Flash Ultrasound System 5100 POC, a breakthrough point-of-care ultrasound system designed for fast-paced settings like anesthesia, critical care, emergency medicine, and musculoskeletal imaging. Built on Philips’ cardiology and imaging technology, the system offered high image clarity, smart automation, and a user-friendly touchscreen. Its portable design and encounter-based workflow allowed clinicians to perform and document exams in real time, supporting rapid decision-making in high-pressure environments such as the ER and ICU.
“The Philips Flash 5100 POC represents a major leap forward in our commitment to Point-of-Care ultrasound innovation,” said Jeff Cohen, Global Business Leader of Ultrasound at Philips. “It’s built to empower health systems to act faster and treat smarter, delivering critical information to clinicians and non-traditional ultrasound users in the most time-sensitive and demanding environments. Designed for speed, mobility, and precision, it empowers clinicians to make confident, real-time decisions in the most urgent settings—at the bedside, in the ICU, the emergency department, or the OR. With advanced algorithms and smart automation, Flash 5100 POC delivers the critical information clinicians need—when and where they need it most.”
Philips supported around 52 million point-of-care procedures annually, aiding in the diagnosis and treatment of 41 million patients worldwide. The launch of the Flash 5100 POC marked a major advancement in meeting the demand for fast, high-performance ultrasound imaging. It featured future-ready software, cross-platform transducer compatibility, including the mL26-8 for MSK use, and integrated with Philips’ POC ecosystem, including Lumify and the Compact 5000 Series. Philips also advanced innovation with two FDA-cleared AI applications for Lumify and received additional FDA clearances for the next-gen Compact 5000 Series in March, reinforcing its commitment to smarter, faster frontline care.
As per 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 2024 to 2030. 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 2024 to 2030.
Article in PDF
Jun 19, 2025
Table of Contents
On June 12, 2025, San Mateo, California–Presidio Medical, Inc., a global clinical-stage medical device company, received Investigational New Drug (IDE) approval from the U.S. FDA to initiate its global, pivotal randomized controlled trial, the FULFILL Study, in both the United States and Australia. The study will evaluate the company’s proprietary Ultra Low Frequency (ULF™) neuromodulation platform, which delivers therapy through leads implanted in the epidural space, commonly referred to as Spinal Cord Stimulation (SCS).
Presidio Medical is focused on advancing patient-centered technologies, specifically a novel approach to treating chronic nociceptive low back pain. The ULF neuromodulation platform is engineered to alleviate localized pain by diminishing neuronal activity, potentially offering sustained relief for patients who currently lack effective treatment options. As there are no approved SCS therapies for nociceptive back pain, this represents a significant unmet need in a market estimated at $20 billion.
Additionally, the company is pleased to welcome Dimas Jiménez as its new Chief Financial Officer (CFO). Mr. Jiménez brings more than 40 years of financial expertise, with experience ranging from Wall Street to leadership roles in both established and emerging life science companies. In his new role, he will focus on strengthening Presidio’s financial infrastructure, supporting the commercialization of the ULF neuromodulation system, and enhancing engagement with current and prospective investors.
“IDE approval from the FDA represents a significant milestone for Presidio and enables the study of ultra low frequency modulation of the nervous system. The results from our first-in-human clinical trial in Australia, which were presented by Dr. Marc Russo at NANS earlier this year, were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform,” said Michael Onuscheck, Presidio Medical’s Chief Executive Officer.
“We are extremely pleased to welcome Dimas to the Presidio team. The breadth and depth of his experience within the life science industry and his expertise in working with pre-commercialization start-up organizations is invaluable as we continue to grow and evolve as a company,” said Onuscheck.
“Presidio’s ULF platform has the potential to greatly improve the lives of patients who suffer from debilitating chronic back pain. I’ve spent a significant amount of my career working with companies whose goal is to disrupt the status quo. I couldn’t be more excited to be a part of this mission-driven and patient-centric organization,” said Jiménez.
As per DelveInsight’s “Neuromodulation Devices Market Report”, the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities, along with collaborations among key players, are significantly contributing to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
On June 11, 2025, Creo Medical announced that the U.S. Food and Drug Administration (FDA) granted clearance for our SpydrBlade™ Flex device, a major achievement for Creo, completing FDA approvals across our full portfolio of advanced energy gastrointestinal (GI) products.
SpydrBlade™ Flex is an innovative, multi-functional endoscopic tool that delivers both cutting and coagulation capabilities—features traditionally limited to laparoscopic surgery through a flexible endoscope. Designed to support a wide range of therapeutic endoscopy procedures, the device offers unmatched precision, adaptability, and versatility, equipping clinicians with a powerful solution to streamline complex interventions and drive broader clinical adoption.
Since its successful commercial debut in Europe in March 2025, SpydrBlade™ Flex has already proven its clinical utility in procedures such as Zenker’s Peroral Endoscopic Myotomy (Z-POEM), Colonic Endoscopic Submucosal Dissection (ESD), Oesophageal ESD, POEM, and F-POEM
With FDA clearance now in place, Creo is set to begin commercial rollout in the U.S., supported by its robust direct sales team and a well-established network of leading clinical experts.
Craig Gulliford, Chief Executive Officer of Creo, said: “This is a proud and pivotal moment for Creo. FDA clearance for SpydrBlade™ Flex confirms the strength and novelty of our GI product portfolio. The device has overcome significant design challenges, with unique intellectual property that sets it apart in the market.”
“Professor Robert Hawes, MD, once described SpydrBlade™ Flex as ‘the harmonic scalpel at the end of a flexible scope,’ which perfectly encapsulates our goal: bringing operating room capability into flexible endoscopy.”
“With a clear path to reimbursement and a ready-to-deploy sales infrastructure, we’re excited about bringing SpydrBlade™ Flex to clinicians and patients across the United States.”
As per DelveInsight’s “Endoscopes Market Report”, the endoscopes market was valued at USD 12.95 billion in 2023, growing at a CAGR of 6.05% during the forecast period from 2024 to 2030 to reach USD 18.32 billion by 2030. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic disease which require the use of endoscopes for diagnosis, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and crohn’s disease, increase in number of geriatric population who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2024 to 2030.
On June 16, 2025, Penumbra, Inc., a global leader in thrombectomy, announced the completion of patient enrollment in the STORM-PE clinical trial, a pivotal, prospective, multi-center randomized controlled study. The trial enrolled 100 patients to compare the effectiveness of computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash™ system combined with anticoagulation therapy, against anticoagulation therapy alone, for treating acute intermediate-high risk pulmonary embolism (PE).
Conducted in collaboration with The PERT Consortium®, a multidisciplinary organization focused on enhancing PE patient care, the study aims to generate high-quality evidence on the benefits of CAVT in improving right heart function and clinical outcomes in this critically ill population.
In the United States, approximately 900,000 cases of symptomatic PE are reported each year, with 10–30% of affected individuals dying within one month of diagnosis, underscoring the severity of the condition.
Penumbra’s Lightning Flash system represents the most advanced mechanical thrombectomy technology available for treating venous and pulmonary thrombi. Incorporating the company’s Lightning CAVT platform, it features state-of-the-art dual clot detection algorithms that utilize both pressure and flow sensing to distinguish between clot and blood flow. The system includes a MaxID hypotube-based catheter, offering a large inner diameter while maintaining a slim, flexible profile with a soft, atraumatic tip—designed to ensure efficient, safe, and streamlined clot removal, even within the body’s complex vascular anatomy.
“This is an important milestone that underscores Penumbra’s commitment to transforming care for patients with pulmonary embolism,” said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “The trial successfully randomized patients well ahead of schedule thanks to the dedication of our clinical partners and the tireless efforts of our internal teams.”
“Pulmonary embolism remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high risk patients are not well defined,” said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE and hematologist at the Massachusetts General Hospital. “The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care.”
As per DelveInsight’s “Thrombectomy Devices Market Report”, the thrombectomy devices market is poised for significant growth, projected to achieve a remarkable CAGR of 5.24% during the forecast period from 2024 to 2030. The demand for thrombectomy devices is being boosted by the increasing prevalence of lifestyle disorders such as low blood pressure, diabetes, obesity, age, and others. Further, the increasing prevalence of venous thromboembolism, cardiovascular diseases, cancer, and neurological diseases, such as ischemic stroke, hemorrhagic stroke, and peripheral diseases, among other,s will lead to the formation of blood clots, thereby leading to the increased demand for thrombectomy devices.
In addition, the increasing demand for minimally invasive approaches for treatment, lack of physical activity, rising adoption of smoking, rising device launches and approvals, surging innovations in product development, and shifting key players’ focus towards the development of technologically advanced product and initiatives to increase awareness regarding neurovascular diseases and their prevention among others are thereby contributing to the overall growth of the thrombectomy devices market during the forecast period from 2024 to 2030.
On June 17, 2025, Adona Medical, a portfolio company of Shifamed, announced the successful completion of enrollment in its ATHENS-HF first-in-human clinical study. The company is developing one of the world’s first cardiovascular implants that combines both therapeutic and diagnostic capabilities. In this study, its chronically adjustable interatrial shunt, integrated with bi-atrial pressure monitoring, was implanted in 10 heart failure patients, achieving a 100% procedural success rate. Each patient underwent successful adjustment of the shunt diameter, both increasing and decreasing from the original setting, with measurable effects observed based on the size changes.
The ATHENS-HF study included patients with both preserved and reduced ejection fraction heart failure. Most participants have now reached the 90-day follow-up milestone and, as planned, underwent additional procedures to modify the shunt size months after the initial implantation. To date, there have been no major procedural complications or site-reported major adverse cardiovascular and neurovascular events (MACNE). Adona plans to present the primary endpoint results from the study later this year.
The company’s device incorporates a uniquely adjustable flow channel, enabling more personalized treatment than traditional shunt technologies with fixed geometries. Additionally, the device includes embedded sensors that automatically collect pressure data from both atria several times daily without requiring any action from the patient. This continuous monitoring offers clinicians a more comprehensive view of a patient’s hemodynamic condition and has the potential to enhance shunt therapy by supporting more precise and proactive treatment decisions.
“A ‘one-size-fits-all’ technology may not be an optimal approach for all patients because heart failure is a diverse and evolving condition. The ideal shunting solution would enable adaptive flow rates and provide hemodynamic feedback so that the shunt device could be adjusted to optimize therapy based on the patient’s needs, similar to calibrating for optimal medical therapy,” shared Gregg W. Stone, MD, FACC, MSCAI, Mount Sinai Heart Health System and Co-Principal Investigator for the ATHENS-HF study. “The Adona interatrial shunt is designed to allow for tailored hemodynamic modulation in response to feedback from the integrated pressure sensors and the patient’s changing clinical status, offering promise to a broad patient population.”
“During the initial cases, I have seen firsthand that the Adona shunt can be safely and reliably deployed, and that the bi-atrial sensors provide important insights into the hemodynamic condition of the patient and the immediate impact of the shunting therapy,” said Gagan Singh, MD, MS, Clinical Cardiovascular Research Unit Director, University of California Davis Health, and Clinical Advisor and Proctor for ATHENS-HF. “Additionally, the early clinical experience preliminarily indicates the shunt diameter can be adjusted smaller or larger post-implantation, allowing for treatment tailored to patient-specific needs.”
According to DelveInsight’s “Tissue Heart Valves Market Report,” the tissue heart valves market is estimated to grow at a CAGR of 7.56% during the forecast period from 2024 to 2030. The demand for tissue heart valves is primarily witnessing growth on account of the high prevalence of heart valve diseases such as aortic valve degeneration and aortic stenosis, the increase in demand for minimally invasive procedures, technological advancements of the tissue heart valves, and the longer life expectancy of the geriatric population.
On June 17, 2025, Johnson & Johnson, a global leader in eye health, announced that it had expanded its portfolio of presbyopia-correcting intraocular lenses (PC-IOL) with the rollout of the TECNIS Odyssey IOL in Europe, the Middle East, and Canada. The new full visual range IOL offered high-quality and continuous vision with an unmatched range. It allowed patients to see clearly from far to near and at intermediate distances, significantly reducing their dependence on glasses. Built on the industry-leading TECNIS platform, which combined advanced optics and proprietary materials, the TECNIS Odyssey IOL delivered consistently clear, high-contrast vision.
“TECNIS Odyssey IOL is the fastest growing PC-IOL in the United States, and we are excited to be making it available to more patients around the world. It addresses a significant unmet need for cataract patients seeking greater spectacle independence. Now, together with TECNIS PureSee, TECNIS Odyssey IOL elevates the strength and depth of our global IOL portfolio, meeting the diverse needs of today’s aging population,” said Peter Menziuso, Company Group Chairman, Vision, Johnson & Johnson.
“From my early experience, what sets the TECNIS Odyssey IOL apart, is its ability to deliver consistent visual outcomes across a wide range of patients, due to its advanced design with higher tolerance to residual refractive error,” said Professor Beatrice Cochener-Lamard, Head of the Ophthalmology Department at Brest University Hospital in France.
Johnson & Johnson launched the TECNIS Odyssey IOL as its latest innovation for enhanced visual freedom, offering clear vision at all distances near, intermediate, and far with minimal reliance on glasses. Its unique diffractive surface provided continuous vision and reduced night-time disturbances like halos and glare. Clinical results showed high patient satisfaction: 94% were pleased with overall vision, 96% with smartphone reading, and 97% with distance vision. The IOL was made available in Europe, the Middle East, Canada, the U.S., Puerto Rico, and Japan. The company also expanded its TECNIS portfolio to include TECNIS PureSee IOL in APAC and Latin America, though it had not received PMA approval in the U.S.
According to DelveInsight’s “Intraocular Lens Market Report”, the global intraocular lens market was valued at USD 4,648.96 million in 2024, growing at a CAGR of 6.12% during the forecast period from 2025 to 2032 to reach USD 7,414.66 million by 2032. The intraocular lens market is being significantly boosted by the growing cases of eye-related disorders such as cataracts, presbyopia, and astigmatism, which are increasing the demand for corrective surgical interventions. This rising disease burden is complemented by improved awareness and accessibility to eye care services, especially in developing regions, enabling more patients to seek treatment. Additionally, ongoing technological advancements in lens materials and designs, such as the development of multifocal and extended depth-of-focus lenses, are enhancing visual outcomes and patient satisfaction. Furthermore, increased product development activities by key market players are leading to the introduction of innovative and customized IOL solutions, collectively accelerating the growth of the global intraocular lens market during the forecast period from 2025 to 2032.
On June 17, 2025, Royal Philips launched the Flash Ultrasound System 5100 POC, a breakthrough point-of-care ultrasound system designed for fast-paced settings like anesthesia, critical care, emergency medicine, and musculoskeletal imaging. Built on Philips’ cardiology and imaging technology, the system offered high image clarity, smart automation, and a user-friendly touchscreen. Its portable design and encounter-based workflow allowed clinicians to perform and document exams in real time, supporting rapid decision-making in high-pressure environments such as the ER and ICU.
“The Philips Flash 5100 POC represents a major leap forward in our commitment to Point-of-Care ultrasound innovation,” said Jeff Cohen, Global Business Leader of Ultrasound at Philips. “It’s built to empower health systems to act faster and treat smarter, delivering critical information to clinicians and non-traditional ultrasound users in the most time-sensitive and demanding environments. Designed for speed, mobility, and precision, it empowers clinicians to make confident, real-time decisions in the most urgent settings—at the bedside, in the ICU, the emergency department, or the OR. With advanced algorithms and smart automation, Flash 5100 POC delivers the critical information clinicians need—when and where they need it most.”
Philips supported around 52 million point-of-care procedures annually, aiding in the diagnosis and treatment of 41 million patients worldwide. The launch of the Flash 5100 POC marked a major advancement in meeting the demand for fast, high-performance ultrasound imaging. It featured future-ready software, cross-platform transducer compatibility, including the mL26-8 for MSK use, and integrated with Philips’ POC ecosystem, including Lumify and the Compact 5000 Series. Philips also advanced innovation with two FDA-cleared AI applications for Lumify and received additional FDA clearances for the next-gen Compact 5000 Series in March, reinforcing its commitment to smarter, faster frontline care.
As per 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 2024 to 2030. 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 2024 to 2030.
