Notizia - Recent Pharma, Healthcare and Biotech Happenings
Dec 11, 2025
Table of Contents
On December 10, 2025, Bendit Technologies announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for the Bendit17™ Microcatheter, which became the smallest steerable microcatheter available on the market. This clearance represented a major advancement in improving precision and accessibility for both neurovascular and peripheral endovascular interventions. With FDA authorization, Bendit introduced its novel technology to physicians and patients across the United States.
By that time, the company had already reached the final stages of production and was preparing to begin its first U.S. commercial clinical procedures in January 2026. Simultaneously, Bendit was working toward obtaining additional regulatory approvals in other global regions. The Bendit17™ Microcatheter offered enhanced steerability and accuracy, allowing physicians to navigate highly complex vascular anatomies with greater control, stability, and ease. Its specialized design aimed to support clinicians across a wide range of challenging vascular procedures.
Click Here To Get the Article in PDF
“FDA clearance of the Bendit17 is a major milestone for our team and a meaningful advancement for clinicians seeking greater control and navigational precision in complex vascular procedures. The device’s capability to navigate with or without a guidewire represents a significant technological leap forward. Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision. We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide.”
As per DelveInsight’s “Neurovascular Catheters Devices Market Report,” the global neurovascular catheters market, valued at USD 3.22 billion in 2023, is expected to grow steadily at a CAGR of 7.25% between 2024 and 2030. Market expansion is being propelled by the rising burden of neurological disorders, particularly stroke, brain aneurysms, arteriovenous malformations (AVMs), and intracranial stenosis, combined with lifestyle factors such as smoking, hypertension, and obesity that increase the risk of neurovascular disease. Growing public and clinical awareness of early diagnosis and minimally invasive treatment options has further encouraged adoption. Additionally, rising disposable income in developing regions is enabling greater access to advanced neurointerventional procedures.
Furthermore, continuous innovation in microcatheters, aspiration catheters, steerable catheters, and distal access catheters, along with frequent FDA approvals and product launches by leading manufacturers, is significantly accelerating market growth. The increasing shift toward minimally invasive neurointerventions, the expansion of stroke-ready centers and comprehensive stroke units, and the growing use of robotic and image-guided navigation systems are also creating new opportunities for catheter demand. Advancements in flexible materials, hydrophilic coatings, and torque-enhanced designs are improving performance and safety, encouraging broader procedural use across complex anatomies. Collectively, these factors are expected to sustain strong global demand for neurovascular catheters throughout the forecast period.
On December 10, 2025, ProVerum Limited, a medical device company dedicated to developing safe and effective solutions for benign prostatic hyperplasia (BPH), announced that it had received FDA approval for its ProVee® System for the treatment of BPH.
The ProVee System was introduced as a next-generation prostatic urethral stent designed to gently expand the obstructed prostate and alleviate lower urinary tract symptoms associated with the condition. It operated without cutting, burning, tearing, or piercing prostatic tissue, offering the potential for a safer profile and faster recovery when compared with more invasive therapeutic options.
Findings from the ProVIDE study supported the FDA approval. This randomized, double-blind, sham-controlled clinical trial evaluated the safety and efficacy of the ProVee System in men with moderate-to-severe BPH. The trial achieved all primary and secondary endpoints, showing significant and durable symptom improvement and enhanced urinary flow over 12 months. No serious adverse events related to the device or procedure were reported; none of the patients required catheterization after the intervention, and sexual function remained preserved throughout follow-up.
BPH has long been recognized as the most common reason men seek care from a urologist, with more than 12 million men in the United States actively treated for the condition. Symptoms such as frequent urination, nocturia, weak urinary stream, and incomplete bladder emptying tend to worsen without intervention and can severely affect quality of life.
“The data from the ProVIDE clinical study are very impressive and make a strong case for the ProVee System to become a first-line interventional therapy to treat BPH,” said Steven A. Kaplan, M.D., Professor of Urology at the Icahn School of Medicine at Mount Sinai and Global Lead Investigator for the study.
“FDA approval of the ProVee System marks a major step forward for ProVerum and for men living with BPH,” said Paul Bateman, CEO of ProVerum. “With the ProVee System, urologists have a safe, effective and straightforward procedure that can deliver meaningful symptom relief and improvement in quality of life.”
As per DelveInsight’s “Benign Prostatic Hyperplasia Devices Market Report,” the global benign prostatic hyperplasia treatment device market size was estimated at USD 1.67 billion in 2024 and is projected to reach USD 3.71 billion by 2030, growing at a CAGR of 9.40% from 2024 to 2030. The market for Benign Prostatic Hyperplasia (BPH) devices is primarily driven by the rising global prevalence of BPH among aging men, increasing demand for minimally invasive and office-based treatment options, and growing awareness of early management of lower urinary tract symptoms. Advancements in non-ablative and tissue-sparing technologies such as prostatic urethral stents, implants, and water-based therapies are further accelerating adoption as they offer quicker recovery, fewer complications, and preservation of sexual function compared to traditional surgeries. Increasing healthcare spending, rapid FDA approvals, strong clinical evidence supporting newer devices, and the shift toward outpatient urology procedures also significantly stimulate market growth.
On December 09, 2025, a2z Radiology AI, a developer of AI technologies for comprehensive medical imaging interpretation, announced that it had raised a $4.5 million seed round with participation from Khosla Ventures and SeaX Ventures. This funding was intended to accelerate the commercial rollout of the company’s FDA-cleared triage system and support further R&D aimed at expanding its broader imaging interpretation capabilities.
The investment followed two major milestones for the company: the FDA clearance of a2z-Unified-Triage, the first U.S. system capable of simultaneously triaging seven urgent conditions on abdomen-pelvis CT scans, and a2z’s debut at RSNA 2025, where it presented the first prospective study assessing AI-assisted preliminary report drafting for abdomen-pelvis CT.
The study showed that AI support reduced reporting time by 17.8%, increased radiologist confidence by 14.8%, and lowered mental demand by 22.4%, while also improving the detection of findings without a rise in false positives. These results offered early evidence that comprehensive imaging AI could meaningfully enhance both diagnostic accuracy and workflow efficiency, addressing longstanding concerns about the practical value of radiology AI in clinical settings.
With imaging volumes growing faster than the radiology workforce, clinicians have been facing increasing delays in receiving critical imaging reads. Abdomen-pelvis CT alone represented more than 20 million exams annually in the U.S., making it the highest-volume CT category. Unlike traditional AI tools focused on a single condition, a2z pursued a comprehensive approach that interprets imaging studies the way radiologists do, evaluating multiple conditions simultaneously to support faster, more accurate clinical decision-making.
“Radiology is central to modern medicine, but delays can slow down care when timely answers are essential,” said Dr. Kid Parchariyanon, Founder and Managing Partner of SeaX Ventures. “a2z is meeting this challenge with technology that brings expert-level support directly to clinicians. We’re proud to support a2z as they build the tools that make a meaningful difference for providers and patients worldwide.”
“Radiology is one of the areas that will benefit the most from AI, ensuring no disease goes undetected,” said Vinod Khosla of Khosla Ventures. “While others focus on single conditions, a2z is able to evaluate imaging for a broad range of issues, bringing us closer to the comprehensive capabilities of a real-life radiologist.”
According to DelveInsight’s “Computed Tomography (CT) Devices Market Report,” the computed tomography devices market was valued at USD 8,400.69 million in 2024, growing at a CAGR of 6.15% from 2025 to 2032, reaching USD 13,460.21 million by 2032. The rising prevalence of chronic diseases, such as cancer, cardiovascular disorders, and respiratory illnesses, significantly increases the demand for diagnostic imaging, making computed tomography (CT) devices essential for early detection and monitoring. Additionally, technological advancements, including faster scanning speeds, enhanced image resolution, and lower radiation exposure, make CT devices more efficient and safer, encouraging wider adoption by healthcare providers. Furthermore, key market players are continually developing innovative products, such as portable, AI-integrated CT systems, that improve diagnostic accuracy and expand the use of CT devices across various medical fields. Collectively, these factors are expected to boost the market for computed tomography devices during the forecast period from 2025 to 2032.
On December 09, 2025, MedINT announced the commercial launch of the first human-in-the-loop medical AI platform that was designed to give clinicians full control over evidence review and treatment decisions for complex patients. The system maintained clinician oversight at every stage by providing patient-specific evidence summaries that supported rather than replaced clinical judgment.
Medical knowledge had been expanding faster than practitioners could absorb. More than 2.5 million biomedical papers were being published each year (National Institutes of Health, 2025), and a 2024 Doximity survey indicated that 70% of physicians felt overwhelmed by the volume of reading required to stay current. MedINT was developed to address this widening gap. After being tested with leading clinicians across multiple specialties, the platform functioned as a secure, cloud-based clinical decision support system suitable for multidisciplinary environments such as tumor boards.
The platform integrated advanced AI with transparent, human-centered validation tools, allowing clinicians to verify sources, assess study quality, and consider patient-specific factors in real time. This framework ensured that AI-generated insights enhanced, rather than bypassed, expert medical reasoning.
Complex cases often involved overlapping diseases, rare clinical profiles, and conflicting research, making interpretation difficult. With more than 50% of U.S. adults reporting multiple chronic conditions (CDC, 2025), clinicians require tools that strengthen their expertise.
Because medical decisions carried high stakes and because clinical research varied widely in quality, patients with complex needs were often excluded from clinical trials. Without appropriate safeguards, automated systems risked applying weak evidence or generating overconfident recommendations, compromising clinical reliability and putting patients at risk.
“As a hematologist, much of my work involves caring for patients who do not fit neatly into standard guidelines. They have multiple comorbidities, prior therapies, or rare presentations that turn each treatment plan into a high-stakes judgment call. Even when you follow the literature closely, translating heterogeneous data into clear options for a specific patient remains a major challenge. A platform like MedINT, which provides verified, patient-specific evidence without replacing my clinical judgment, is exactly the kind of support physicians need to make safer, more confident decisions for complex patients,” said Dr. Yotam Bronstein, hematologist, Tel Aviv Medical Center.
According to DelveInsight’s “Clinical Decision Support Systems Market Report”, the global clinical decision support systems (CDDS) market was valued at USD 2.23 billion in 2023, growing at a CAGR of 6.62% from 2024 to 2030, reaching USD 3.28 billion by 2030. The increase in demand for clinical decision support systems is primarily attributed to the increasing pool of patients due to the growing prevalence of chronic disorders and due to unhealthy lifestyles and habits. Moreover, the surging patient demand for improved quality of care will bolster the market for clinical decision systems during the study period. Furthermore, the growing global demand for intelligent software solutions in the healthcare sector will increase demand for the CDDS. Additionally, the CDDS may provide remote patient care, thereby reducing patient hospitalizations and overall healthcare expenditure. Thus, the need to reduce healthcare expenditure worldwide is expected to bolster the market, thereby contributing to the growth of the clinical decision support systems market during the forecast period from 2024 to 2030.
On December 10, 2025, Nitinotes Ltd., an early commercial–stage medtech company focused on fully automated endoluminal suturing solutions for obesity treatment, announced that it had treated its first patient in the U.S. Investigational Device Exemption (IDE) EASE™ Clinical Trial evaluating the EndoZip™ Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure had been performed at Lenox Hill Hospital | Northwell Health in New York, NY, which served as the first activated U.S. site for the study.
Globally, obesity has affected more than 650 million adults and continues to be a major contributor to metabolic diseases, with many individuals unable to achieve sustained weight loss through lifestyle modification or medication alone. ESG had become an increasingly important minimally invasive alternative, driving demand for technologies that improved consistency, ease of use, and standardization of the procedure.
The EASE™ Clinical Trial was structured as a prospective, multicenter, randomized, two-arm, blinded pivotal study to assess the safety and effectiveness of the automated EndoZip™ ESG procedure compared with the manual Apollo OverStitch® ESG method. Beyond clinical outcomes, the study also sought physician-reported feedback on procedural experience, including usability and workflow efficiency. The trial planned enrollment of up to 184 patients across up to 10 sites in the United States and Europe, with a 12-month follow-up period. Its design aligned with FDA guidance and was intended to support a future regulatory submission in the U.S.
This first-patient milestone came shortly after the company had received CE Mark approval for EndoZip™, paving the way for its commercial rollout in the European Union and other CE Mark–accepting regions.
“Our mission is to advance the role of automation in obesity treatment by generating high-quality clinical evidence that informs regulatory review and enables broader clinical adoption,” added Lloyd Diamond, CEO of Nitinotes. “The first patient treated in the EASE trial is a significant step forward in that mission and builds on the momentum of our recent CE Mark approval. We appreciate Dr. Shamah and the Lenox Hill | Northwell Health team for their leadership as additional U.S. and European sites prepare to initiate enrollment.”
According to DelveInsight’s “Bariatric Surgery Devices Market Report,” the global bariatric surgery devices market was valued at USD 2,082 million in 2023, growing at a CAGR of 5.22% during the forecast period from 2024 to 2030 to reach USD 2,823 million by 2030. The increase in demand for bariatric surgery devices is primarily attributed to the increasing prevalence of obesity due to a sedentary and unhealthy lifestyle. Furthermore, childhood obesity is rising at an alarming rate. Moreover, due to severe and untreated obesity, chronic diseases like excessive cholesterol, hypertension, and diabetes are rising steeply, thereby propelling the market growth of the product. Furthermore, rising demand for minimally invasive surgeries and pain-free surgeries is thus increasing the demand for the device. Additionally, the demand for bariatric surgery is growing, so the availability of surgeons specializing in bariatric surgery is rising, ultimately increasing the number of surgical procedures and product demand. Moreover, the government is expanding support and awareness of unhealthy foods and drinks, increasing funding for bariatric surgery in developed countries worldwide, which is expected to bolster the market, thereby contributing to the growth of the bariatric surgery devices market during the forecast period from 2024 to 2030.
On December 10, 2025, Airiver Medical, a clinical-stage company developing technologies for patients with respiratory tract disorders, announced that it had received Investigational Device Exemption (IDE) approval from the U.S. FDA, allowing the company to launch a pivotal clinical trial of the Airiver ESSpand Sinus Drug-Coated Balloon (DCB) for chronic rhinosinusitis (CRS).
The pivotal study was designed to enroll up to 300 patients with CRS with or without nasal polyps across multiple sites in the U.S. Its purpose was to evaluate the safety and effectiveness of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The ESSpand DCB device was engineered to help maintain symptom improvement and prevent postoperative scarring or restenosis by delivering a thin layer of a proprietary paclitaxel coating directly to the targeted tissue during balloon dilation of the obstructed sinus drainage pathways. Data from this trial were expected to form the foundation of Airiver Medical’s future FDA regulatory submission and potential U.S. commercialization.
“Securing IDE approval for this study means we are one step closer to being able to offer chronic rhinosinusitis patients a treatment option that has the potential to finally give them the long-term relief they’ve been waiting for with fewer treatments,” said Lixiao Wang, founder, chief executive officer, and chief technology officer for Airiver Medical.
According to DelveInsight’s “Sinus Dilation Devices Market Report”, the global sinus dilation devices market is expected to increase from USD 3,204.77 million in 2024 to USD 6,527.14 million by 2032, reflecting strong and sustained growth at a CAGR of 9.38% during the forecast period from 2025 to 2032. The rising cases of spinal disorders, particularly among aging populations, have significantly increased the demand for corrective surgical interventions. Simultaneously, the surge in sports-related and accident-induced spinal injuries is fueling the need for advanced implantable solutions. Moreover, there is a growing preference for non-fusion and motion preservation devices that maintain spinal mobility and enhance patient outcomes, especially among younger and more active individuals. Coupled with this is an uptick in product development and technological innovation by key market players globally, expanding the range of available solutions and improving surgical success rates. Together, these trends are accelerating the adoption of spinal implants and driving the overall market during the forecast period from 2025 to 2032.
Article in PDF
Dec 11, 2025
Table of Contents
On December 10, 2025, Bendit Technologies announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for the Bendit17™ Microcatheter, which became the smallest steerable microcatheter available on the market. This clearance represented a major advancement in improving precision and accessibility for both neurovascular and peripheral endovascular interventions. With FDA authorization, Bendit introduced its novel technology to physicians and patients across the United States.
By that time, the company had already reached the final stages of production and was preparing to begin its first U.S. commercial clinical procedures in January 2026. Simultaneously, Bendit was working toward obtaining additional regulatory approvals in other global regions. The Bendit17™ Microcatheter offered enhanced steerability and accuracy, allowing physicians to navigate highly complex vascular anatomies with greater control, stability, and ease. Its specialized design aimed to support clinicians across a wide range of challenging vascular procedures.
“FDA clearance of the Bendit17 is a major milestone for our team and a meaningful advancement for clinicians seeking greater control and navigational precision in complex vascular procedures. The device’s capability to navigate with or without a guidewire represents a significant technological leap forward. Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision. We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide.”
As per DelveInsight’s “Neurovascular Catheters Devices Market Report,” the global neurovascular catheters market, valued at USD 3.22 billion in 2023, is expected to grow steadily at a CAGR of 7.25% between 2024 and 2030. Market expansion is being propelled by the rising burden of neurological disorders, particularly stroke, brain aneurysms, arteriovenous malformations (AVMs), and intracranial stenosis, combined with lifestyle factors such as smoking, hypertension, and obesity that increase the risk of neurovascular disease. Growing public and clinical awareness of early diagnosis and minimally invasive treatment options has further encouraged adoption. Additionally, rising disposable income in developing regions is enabling greater access to advanced neurointerventional procedures.
Furthermore, continuous innovation in microcatheters, aspiration catheters, steerable catheters, and distal access catheters, along with frequent FDA approvals and product launches by leading manufacturers, is significantly accelerating market growth. The increasing shift toward minimally invasive neurointerventions, the expansion of stroke-ready centers and comprehensive stroke units, and the growing use of robotic and image-guided navigation systems are also creating new opportunities for catheter demand. Advancements in flexible materials, hydrophilic coatings, and torque-enhanced designs are improving performance and safety, encouraging broader procedural use across complex anatomies. Collectively, these factors are expected to sustain strong global demand for neurovascular catheters throughout the forecast period.
On December 10, 2025, ProVerum Limited, a medical device company dedicated to developing safe and effective solutions for benign prostatic hyperplasia (BPH), announced that it had received FDA approval for its ProVee® System for the treatment of BPH.
The ProVee System was introduced as a next-generation prostatic urethral stent designed to gently expand the obstructed prostate and alleviate lower urinary tract symptoms associated with the condition. It operated without cutting, burning, tearing, or piercing prostatic tissue, offering the potential for a safer profile and faster recovery when compared with more invasive therapeutic options.
Findings from the ProVIDE study supported the FDA approval. This randomized, double-blind, sham-controlled clinical trial evaluated the safety and efficacy of the ProVee System in men with moderate-to-severe BPH. The trial achieved all primary and secondary endpoints, showing significant and durable symptom improvement and enhanced urinary flow over 12 months. No serious adverse events related to the device or procedure were reported; none of the patients required catheterization after the intervention, and sexual function remained preserved throughout follow-up.
BPH has long been recognized as the most common reason men seek care from a urologist, with more than 12 million men in the United States actively treated for the condition. Symptoms such as frequent urination, nocturia, weak urinary stream, and incomplete bladder emptying tend to worsen without intervention and can severely affect quality of life.
“The data from the ProVIDE clinical study are very impressive and make a strong case for the ProVee System to become a first-line interventional therapy to treat BPH,” said Steven A. Kaplan, M.D., Professor of Urology at the Icahn School of Medicine at Mount Sinai and Global Lead Investigator for the study.
“FDA approval of the ProVee System marks a major step forward for ProVerum and for men living with BPH,” said Paul Bateman, CEO of ProVerum. “With the ProVee System, urologists have a safe, effective and straightforward procedure that can deliver meaningful symptom relief and improvement in quality of life.”
As per DelveInsight’s “Benign Prostatic Hyperplasia Devices Market Report,” the global benign prostatic hyperplasia treatment device market size was estimated at USD 1.67 billion in 2024 and is projected to reach USD 3.71 billion by 2030, growing at a CAGR of 9.40% from 2024 to 2030. The market for Benign Prostatic Hyperplasia (BPH) devices is primarily driven by the rising global prevalence of BPH among aging men, increasing demand for minimally invasive and office-based treatment options, and growing awareness of early management of lower urinary tract symptoms. Advancements in non-ablative and tissue-sparing technologies such as prostatic urethral stents, implants, and water-based therapies are further accelerating adoption as they offer quicker recovery, fewer complications, and preservation of sexual function compared to traditional surgeries. Increasing healthcare spending, rapid FDA approvals, strong clinical evidence supporting newer devices, and the shift toward outpatient urology procedures also significantly stimulate market growth.
On December 09, 2025, a2z Radiology AI, a developer of AI technologies for comprehensive medical imaging interpretation, announced that it had raised a $4.5 million seed round with participation from Khosla Ventures and SeaX Ventures. This funding was intended to accelerate the commercial rollout of the company’s FDA-cleared triage system and support further R&D aimed at expanding its broader imaging interpretation capabilities.
The investment followed two major milestones for the company: the FDA clearance of a2z-Unified-Triage, the first U.S. system capable of simultaneously triaging seven urgent conditions on abdomen-pelvis CT scans, and a2z’s debut at RSNA 2025, where it presented the first prospective study assessing AI-assisted preliminary report drafting for abdomen-pelvis CT.
The study showed that AI support reduced reporting time by 17.8%, increased radiologist confidence by 14.8%, and lowered mental demand by 22.4%, while also improving the detection of findings without a rise in false positives. These results offered early evidence that comprehensive imaging AI could meaningfully enhance both diagnostic accuracy and workflow efficiency, addressing longstanding concerns about the practical value of radiology AI in clinical settings.
With imaging volumes growing faster than the radiology workforce, clinicians have been facing increasing delays in receiving critical imaging reads. Abdomen-pelvis CT alone represented more than 20 million exams annually in the U.S., making it the highest-volume CT category. Unlike traditional AI tools focused on a single condition, a2z pursued a comprehensive approach that interprets imaging studies the way radiologists do, evaluating multiple conditions simultaneously to support faster, more accurate clinical decision-making.
“Radiology is central to modern medicine, but delays can slow down care when timely answers are essential,” said Dr. Kid Parchariyanon, Founder and Managing Partner of SeaX Ventures. “a2z is meeting this challenge with technology that brings expert-level support directly to clinicians. We’re proud to support a2z as they build the tools that make a meaningful difference for providers and patients worldwide.”
“Radiology is one of the areas that will benefit the most from AI, ensuring no disease goes undetected,” said Vinod Khosla of Khosla Ventures. “While others focus on single conditions, a2z is able to evaluate imaging for a broad range of issues, bringing us closer to the comprehensive capabilities of a real-life radiologist.”
According to DelveInsight’s “Computed Tomography (CT) Devices Market Report,” the computed tomography devices market was valued at USD 8,400.69 million in 2024, growing at a CAGR of 6.15% from 2025 to 2032, reaching USD 13,460.21 million by 2032. The rising prevalence of chronic diseases, such as cancer, cardiovascular disorders, and respiratory illnesses, significantly increases the demand for diagnostic imaging, making computed tomography (CT) devices essential for early detection and monitoring. Additionally, technological advancements, including faster scanning speeds, enhanced image resolution, and lower radiation exposure, make CT devices more efficient and safer, encouraging wider adoption by healthcare providers. Furthermore, key market players are continually developing innovative products, such as portable, AI-integrated CT systems, that improve diagnostic accuracy and expand the use of CT devices across various medical fields. Collectively, these factors are expected to boost the market for computed tomography devices during the forecast period from 2025 to 2032.
On December 09, 2025, MedINT announced the commercial launch of the first human-in-the-loop medical AI platform that was designed to give clinicians full control over evidence review and treatment decisions for complex patients. The system maintained clinician oversight at every stage by providing patient-specific evidence summaries that supported rather than replaced clinical judgment.
Medical knowledge had been expanding faster than practitioners could absorb. More than 2.5 million biomedical papers were being published each year (National Institutes of Health, 2025), and a 2024 Doximity survey indicated that 70% of physicians felt overwhelmed by the volume of reading required to stay current. MedINT was developed to address this widening gap. After being tested with leading clinicians across multiple specialties, the platform functioned as a secure, cloud-based clinical decision support system suitable for multidisciplinary environments such as tumor boards.
The platform integrated advanced AI with transparent, human-centered validation tools, allowing clinicians to verify sources, assess study quality, and consider patient-specific factors in real time. This framework ensured that AI-generated insights enhanced, rather than bypassed, expert medical reasoning.
Complex cases often involved overlapping diseases, rare clinical profiles, and conflicting research, making interpretation difficult. With more than 50% of U.S. adults reporting multiple chronic conditions (CDC, 2025), clinicians require tools that strengthen their expertise.
Because medical decisions carried high stakes and because clinical research varied widely in quality, patients with complex needs were often excluded from clinical trials. Without appropriate safeguards, automated systems risked applying weak evidence or generating overconfident recommendations, compromising clinical reliability and putting patients at risk.
“As a hematologist, much of my work involves caring for patients who do not fit neatly into standard guidelines. They have multiple comorbidities, prior therapies, or rare presentations that turn each treatment plan into a high-stakes judgment call. Even when you follow the literature closely, translating heterogeneous data into clear options for a specific patient remains a major challenge. A platform like MedINT, which provides verified, patient-specific evidence without replacing my clinical judgment, is exactly the kind of support physicians need to make safer, more confident decisions for complex patients,” said Dr. Yotam Bronstein, hematologist, Tel Aviv Medical Center.
According to DelveInsight’s “Clinical Decision Support Systems Market Report”, the global clinical decision support systems (CDDS) market was valued at USD 2.23 billion in 2023, growing at a CAGR of 6.62% from 2024 to 2030, reaching USD 3.28 billion by 2030. The increase in demand for clinical decision support systems is primarily attributed to the increasing pool of patients due to the growing prevalence of chronic disorders and due to unhealthy lifestyles and habits. Moreover, the surging patient demand for improved quality of care will bolster the market for clinical decision systems during the study period. Furthermore, the growing global demand for intelligent software solutions in the healthcare sector will increase demand for the CDDS. Additionally, the CDDS may provide remote patient care, thereby reducing patient hospitalizations and overall healthcare expenditure. Thus, the need to reduce healthcare expenditure worldwide is expected to bolster the market, thereby contributing to the growth of the clinical decision support systems market during the forecast period from 2024 to 2030.
On December 10, 2025, Nitinotes Ltd., an early commercial–stage medtech company focused on fully automated endoluminal suturing solutions for obesity treatment, announced that it had treated its first patient in the U.S. Investigational Device Exemption (IDE) EASE™ Clinical Trial evaluating the EndoZip™ Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure had been performed at Lenox Hill Hospital | Northwell Health in New York, NY, which served as the first activated U.S. site for the study.
Globally, obesity has affected more than 650 million adults and continues to be a major contributor to metabolic diseases, with many individuals unable to achieve sustained weight loss through lifestyle modification or medication alone. ESG had become an increasingly important minimally invasive alternative, driving demand for technologies that improved consistency, ease of use, and standardization of the procedure.
The EASE™ Clinical Trial was structured as a prospective, multicenter, randomized, two-arm, blinded pivotal study to assess the safety and effectiveness of the automated EndoZip™ ESG procedure compared with the manual Apollo OverStitch® ESG method. Beyond clinical outcomes, the study also sought physician-reported feedback on procedural experience, including usability and workflow efficiency. The trial planned enrollment of up to 184 patients across up to 10 sites in the United States and Europe, with a 12-month follow-up period. Its design aligned with FDA guidance and was intended to support a future regulatory submission in the U.S.
This first-patient milestone came shortly after the company had received CE Mark approval for EndoZip™, paving the way for its commercial rollout in the European Union and other CE Mark–accepting regions.
“Our mission is to advance the role of automation in obesity treatment by generating high-quality clinical evidence that informs regulatory review and enables broader clinical adoption,” added Lloyd Diamond, CEO of Nitinotes. “The first patient treated in the EASE trial is a significant step forward in that mission and builds on the momentum of our recent CE Mark approval. We appreciate Dr. Shamah and the Lenox Hill | Northwell Health team for their leadership as additional U.S. and European sites prepare to initiate enrollment.”
According to DelveInsight’s “Bariatric Surgery Devices Market Report,” the global bariatric surgery devices market was valued at USD 2,082 million in 2023, growing at a CAGR of 5.22% during the forecast period from 2024 to 2030 to reach USD 2,823 million by 2030. The increase in demand for bariatric surgery devices is primarily attributed to the increasing prevalence of obesity due to a sedentary and unhealthy lifestyle. Furthermore, childhood obesity is rising at an alarming rate. Moreover, due to severe and untreated obesity, chronic diseases like excessive cholesterol, hypertension, and diabetes are rising steeply, thereby propelling the market growth of the product. Furthermore, rising demand for minimally invasive surgeries and pain-free surgeries is thus increasing the demand for the device. Additionally, the demand for bariatric surgery is growing, so the availability of surgeons specializing in bariatric surgery is rising, ultimately increasing the number of surgical procedures and product demand. Moreover, the government is expanding support and awareness of unhealthy foods and drinks, increasing funding for bariatric surgery in developed countries worldwide, which is expected to bolster the market, thereby contributing to the growth of the bariatric surgery devices market during the forecast period from 2024 to 2030.
On December 10, 2025, Airiver Medical, a clinical-stage company developing technologies for patients with respiratory tract disorders, announced that it had received Investigational Device Exemption (IDE) approval from the U.S. FDA, allowing the company to launch a pivotal clinical trial of the Airiver ESSpand Sinus Drug-Coated Balloon (DCB) for chronic rhinosinusitis (CRS).
The pivotal study was designed to enroll up to 300 patients with CRS with or without nasal polyps across multiple sites in the U.S. Its purpose was to evaluate the safety and effectiveness of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The ESSpand DCB device was engineered to help maintain symptom improvement and prevent postoperative scarring or restenosis by delivering a thin layer of a proprietary paclitaxel coating directly to the targeted tissue during balloon dilation of the obstructed sinus drainage pathways. Data from this trial were expected to form the foundation of Airiver Medical’s future FDA regulatory submission and potential U.S. commercialization.
“Securing IDE approval for this study means we are one step closer to being able to offer chronic rhinosinusitis patients a treatment option that has the potential to finally give them the long-term relief they’ve been waiting for with fewer treatments,” said Lixiao Wang, founder, chief executive officer, and chief technology officer for Airiver Medical.
According to DelveInsight’s “Sinus Dilation Devices Market Report”, the global sinus dilation devices market is expected to increase from USD 3,204.77 million in 2024 to USD 6,527.14 million by 2032, reflecting strong and sustained growth at a CAGR of 9.38% during the forecast period from 2025 to 2032. The rising cases of spinal disorders, particularly among aging populations, have significantly increased the demand for corrective surgical interventions. Simultaneously, the surge in sports-related and accident-induced spinal injuries is fueling the need for advanced implantable solutions. Moreover, there is a growing preference for non-fusion and motion preservation devices that maintain spinal mobility and enhance patient outcomes, especially among younger and more active individuals. Coupled with this is an uptick in product development and technological innovation by key market players globally, expanding the range of available solutions and improving surgical success rates. Together, these trends are accelerating the adoption of spinal implants and driving the overall market during the forecast period from 2025 to 2032.
