- 161RegulationSource · Medical Device Network
Glucotrack seeks FDA approval for clinical study of CBGM technology
Glucotrack has submitted an Investigational Device Exemption (IDE) application to the FDA to initiate a clinical study of its continuous blood glucose monitoring (CBGM) technology in the United States. The filing marks a regulatory milestone toward potential market clearance for the glucose monitoring system.
- 162RegulationSource · Medical Device Network
Podcast: The implications of NICE’s formal recommendation for cryoablation’s use in treating kidney tumours
The UK's National Institute for Health and Care Excellence (NICE) has formally recommended cryoablation for treating kidney tumours. Dr David Breen, a consultant abdominal radiologist, discusses the clinical and market implications of this recommendation, which expands the reimbursement and adoption pathway for cryoablation devices in kidney cancer treatment.
- 163RegulationSource · Medical Device Network
Microsure receives CE mark for MUSA-3 system and appoints new CEO
Microsure obtained CE mark approval for its MUSA-3 system and announced Alex Joseph as new chief executive officer, replacing Iwan van Vijfeijken. The CE mark clearance enables the company to market the device in Europe.
- 164MarketSource · Mobi Health News
Latest Middle East partnerships expanding Korean health tech and more briefs
South Korean medtech firms ROKIT Healthcare and Seers have signed partnerships with Middle Eastern healthcare companies to expand their AI-enabled monitoring and diagnostic technologies. ROKIT Healthcare licensed its chronic kidney disease prediction AI algorithm to Saudi Arabia-based LifeHope for integration into its Longevity platform, while Seers expanded its inpatient monitoring capabilities through a separate regional partnership.
- 165RegulationSource · Medical Design & Outsourcing
FDA warns of neurosurgical device shortage after Medline recall
The FDA has added neurosurgical patties, sponges, and strips to its medical device shortage list following a Class 2 recall of Medline Industries neurosurgical sponge products. The agency warned healthcare providers that the shortage could persist through 2026, citing supplier disruptions as the underlying cause.
- 166TechnologySource · Healthcare IT News
Point solution sprawl is real, and agentic AI could help
Healthcare IT systems face fragmentation from multiple point solutions, and agentic AI may offer a path to better integration and workflow automation. The piece discusses how AI agents could help coordinate disparate systems and reduce operational complexity for hospital and clinical IT operations.
- 167RegulationSource · Medical Design & Outsourcing
FDA pilots program for more facilities inspections
The FDA has launched a pilot program using artificial intelligence to identify low-risk medical device and manufacturing facilities for streamlined one-day inspectional assessments, both domestically and internationally. FDA Commissioner Marty Makary announced the initiative at the Food and Drug Law Institute Annual Conference, aiming to make inspections more targeted and efficient.
- 168MarketSource · Medical Device Network
BD uplifts FY26 revenue outlook based on steady portfolio performance
Becton Dickinson raised its FY26 revenue guidance, reversing a prior downward revision from Q1 that stemmed from the divestiture of its diagnostics business to Waters Corporation. The uplift reflects improved performance across BD's remaining portfolio.
- 169RegulationSource · Medical Device Network
Artera hits US first with pathology-based breast cancer risk tool’s clearance
ArteraAI received US regulatory clearance for ArteraAI Breast, a pathology-based software tool that stratifies breast cancer patients into risk groups to inform treatment decisions. The clearance marks the first such FDA approval for this class of diagnostic software in the US market.
- 170MarketSource · Medical Device Network
Roche to acquire PathAI in $1.05bn deal
Roche signed a definitive merger agreement to acquire PathAI for up to $1.05 billion. PathAI develops AI-powered digital pathology software for analyzing histopathology images. The acquisition expands Roche's diagnostics and AI capabilities in pathology and precision medicine.
- 171New productsSource · Medical Device Network
Xtant Medical launches Trivium Shaped allograft for surgeries
Xtant Medical Holdings has commercially launched Trivium Shaped, a new allograft addition to its Trivium bone graft portfolio. The shaped allograft expands the company's offering for surgical applications.
- 172TechnologySource · Healthcare IT News
Advanced AI holds promise for high-stakes healthcare, studies show
Mayo Clinic researchers demonstrated that REDMOD, an AI-powered radiomics model, can triple radiologists' sensitivity in detecting pancreatic cancer at early, pre-diagnostic stages using routine abdominal CT scans. The system identifies subtle disease markers before tumors become visually apparent, potentially enabling earlier curative intervention. The findings are part of broader research highlighting AI applications in high-stakes diagnostic scenarios.
- 173MarketSource · MedCity News
Startup Enabling Aging at Home Raises $6M, Gains New MA and Medicaid Partnerships
Rosarium Health, a startup focused on aging-in-place solutions, closed a $6 million seed round led by Kalos Ventures with participation from ResilienceVC, Rock Health Capital, and others. The company simultaneously announced new partnerships with Massachusetts and Medicaid programs to expand access to its homecare platform.
- 174TechnologySource · MedCity News
Designing a National-Scale FHIR API Ecosystem Using Apigee: Architecture Patterns for Secure Healthcare Interoperability
A guide addresses technical approaches to building FHIR API infrastructure at national scale using Apigee, focusing on secure interoperability and data exchange between hospital systems. The article explores architecture patterns to reduce data silos in EHR environments and enable cross-system information access.
- 175MarketSource · Medical Device Network
BD and Wellstar partner to improve hospital medication delivery systems
BD and Wellstar Health System have announced a partnership to enhance medication delivery safety and efficiency across Wellstar's hospital and care facility network. The collaboration aims to optimize medication management processes and reduce errors in drug administration.
- 176RegulationSource · Medical Device Network
Medtronic’s VitalFlow Transport Frame AG gains CE mark
Medtronic received CE mark clearance for the VitalFlow Transport Frame AG, an accessory to the VitalFlow ECMO system. The frame is designed to support transport and handling of the extracorporeal membrane oxygenation platform in clinical settings.
- 177TechnologySource · Medical Design & Outsourcing
Hamilton Medical selects PTC Codebeamer ALM
Hamilton Medical, a ventilator and respiratory care equipment maker, has selected PTC's Codebeamer ALM (Application Lifecycle Management) platform to replace its legacy system. The multi-year collaboration aims to enhance product development workflows, improve traceability, and strengthen regulatory compliance across Hamilton Medical's engineering and manufacturing operations. PTC will also work with Hamilton Medical to develop market-specific ALM and PLM (Product Lifecycle Management) capabilities for the medical device sector.
- 178New productsSource · Medical Design & Outsourcing
What’s next for cervical spine tech and startup Synergy Spine Solutions
Synergy Spine Solutions has developed the Synergy Disc, a cervical implant designed with ball-and-socket geometry to improve alignment and preserve range of motion in patients with degenerative disc disease. The device employs proprietary geometry combined with established materials. The startup is positioning itself in the cervical spine implant market with a focus on biomechanical design innovation.
- 179New productsSource · Medical Design & Outsourcing
May 2026 issue: Fighting diabetes with next-gen sensors and drug delivery devices
Medical Design and Outsourcing's May 2026 issue covers next-generation diabetes sensors and drug delivery devices, highlighting advances beyond traditional fingerstick monitoring. The coverage reflects growing momentum in medtech solutions for diabetes management, addressing the expanding patient population through more active device interventions.
- 180MarketSource · Mobi Health News
HealthVerity to acquire data platform Symphony Health
HealthVerity announced plans to acquire Symphony Health, a commercial healthcare data and analytics platform. The combined entity will integrate clinical data with commercial insights to serve life sciences companies, payers, and government entities seeking real-world data, patient research recruitment, and cross-dataset record linkage capabilities.
- 181New productsSource · Medical Device Network
J&J’s soft tissue surgical robot succeeds in pivotal gastric bypass study
Johnson & Johnson's Ottava soft tissue surgical robot completed a pivotal study demonstrating success in gastric bypass procedures. The development positions J&J to compete in the surgical robotics market, currently led by Intuitive Surgical. The study results support Ottava's clinical utility for bariatric surgery applications.
- 182TechnologySource · Mobi Health News
HIMSSCast: Ambient AI scribes pose important regulatory and legal questions
A HIMSSCast podcast episode examines regulatory and legal challenges posed by ambient AI scribing systems in clinical settings. The discussion addresses how these AI-driven documentation tools fit within existing FDA frameworks, liability questions, and compliance considerations for healthcare providers and vendors deploying such technology in electronic health record workflows.
- 183TechnologySource · Medical Device Network
Nitinol’s journey from a guidewire material to an enabler of complex, multifunctional devices
Nitinol, a nickel-titanium alloy known for its shape-memory and superelastic properties, has evolved from its original use in guidewires to enable more complex, multifunctional medical devices. The material's unique characteristics—ability to return to a predetermined shape after deformation and maintain consistent performance—make it suitable for minimally invasive and interventional applications across cardiology, neurology, and other specialties. Manufacturers continue to innovate formulations and processing techniques to expand nitinol's capability in next-generation device designs.
- 184MarketSource · Mobi Health News
Exclusive: XCaliber Health scores $6.5M for workflow platform
XCaliber Health raised $6.5 million in seed funding for its agentic AI platform designed to reduce administrative burden in healthcare settings. The funding will support nationwide expansion of the workflow automation platform.
- 185MarketSource · Medical Device Network
Olympus to distribute EndoRobotics’ technologies worldwide
Olympus has secured an exclusive global distribution agreement for EndoRobotics' robot-assisted technologies, integrating them into its EndoTherapy product portfolio. The deal expands Olympus's surgical robotics offerings to healthcare providers worldwide.
- 186RegulationSource · Medical Device Network
Italy’s new EFS Guidelines: why Europe’s medtech innovation map just changed
Italy has introduced new early feasibility studies (EFS) guidelines for medical devices, according to analysis from BonelliErede's healthcare regulatory team. The guidelines represent a regulatory shift that affects how medtech innovators conduct preliminary device testing in Europe, potentially reshaping the innovation and approval pathway for vendors seeking to establish clinical evidence in the region.
- 187TechnologySource · Medical Design & Outsourcing
Top takeaways from a new study of an AI-integrated capsule gastroscopy (ACG) system
Researchers at Southern Medical University conducted a study on an AI-integrated capsule gastroscopy system designed to address the shortage of endoscopists and endoscopy equipment for upper gastrointestinal diagnosis. The system combines capsule-based imaging with artificial intelligence to expand diagnostic capacity where traditional endoscopy resources are limited.
- 188MarketSource · Medical Design & Outsourcing
Confluent Medical Technologies opens nitinol wire manufacturing facility in India
Confluent Medical Technologies opened a 26,000-square-foot nitinol wire manufacturing facility in Hyderabad, India, doubling its production capacity for the material. The Nitinol Wire Center of Excellence represents the contract manufacturer's investment in expanding supply of nitinol, a shape-memory alloy used in minimally invasive devices and guidewires.
- 189MarketSource · Mobi Health News
Enzo Health raises $20M to expand AI home health platform
Enzo Health, a home health and post-acute care platform using AI, closed a $20 million Series A funding round led by N47, with participation from Gradient, Tandem Ventures, and Rigby Watts. The capital will support expansion of the company's AI-driven home health offerings. Total funding to date is $26 million.
- 190TechnologySource · MedCity News
Sleep Is the Missing Vital Sign, and Health AI Is Scaling the Consequences
Sleep monitoring is emerging as a critical vital sign for understanding cardiovascular, metabolic, immune, and mental health outcomes. Health AI platforms are enabling continuous overnight data collection and analysis to detect near-term changes and long-range risk patterns. The article examines how systematic sleep measurement integrated with AI diagnostics is shifting clinical decision-making and vendor opportunities in remote patient monitoring.
- 191RegulationSource · Medical Device Network
InspireMD issues voluntary recalls for CGuard Prime device in US
InspireMD issued a voluntary recall of its CGuard Prime 135cm carotid stent delivery system in the US following FDA consultation. The company did not disclose the reason for the recall in the available details.
- 192RegulationSource · Medical Device Network
FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent
TaeWoong Medical received FDA 510(k) clearance for the Niti-S Spaxus Stent, an endoscopic ultrasound (EUS)-guided therapeutic stent. The clearance enables US commercialization and expands the company's portfolio of EUS-guided interventional solutions for gastroenterology and related specialties.
- 193New productsSource · Mobi Health News
Oura unveils menopause insights, birth control tools, US Open partnership
Oura, a health-tracking ring manufacturer, launched two new hormonal health features—birth control support and menopause insights—for its wearable device. The company also announced a partnership as the official wearable sponsor of the US Open and USTA.
- 194TechnologySource · Healthcare IT News
HIMSSCast: Ambient AI scribes pose important regulatory and legal questions
Ambient AI scribes are gaining traction as tools to reduce clinician time spent on electronic health record documentation. The technology presents regulatory and legal questions for healthcare IT vendors and EHR providers around liability, compliance, and clinical validation. As adoption accelerates, device makers and software vendors will need to navigate FDA oversight, malpractice frameworks, and data governance standards.
- 195TechnologySource · Mobi Health News
Q&A: AI platform targets clinical chart insights beyond LLM limits
Dyania Health has developed Synapsis AI, a clinical AI platform designed to extract context-driven insights from patient charts and answer specific queries rather than generate generic summaries. The platform addresses limitations of large language models in healthcare by focusing on precise, question-driven analysis of medical records, targeting clinical decision support and operational efficiency in healthcare settings.
- 196MarketSource · Medical Device Network
Stryker maintains FY26 outlook despite cyberattack-impacted Q1
Stryker experienced a cyberattack in March 2026 that disrupted operations and impacted first-quarter performance. Despite the incident, the company maintained its full-year 2026 financial outlook, indicating management confidence in recovery and continued execution of business plans.
- 197New productsSource · Medical Design & Outsourcing
What’s new in Thermoplastic Polyurethanes How ChronoFlex™ S delivers softness and strength for implantable medical devices
ChronoFlex™ S, a thermoplastic polyurethane (TPU) material, addresses a gap in medical-grade polymers for implantable devices by combining softness with mechanical strength and abrasion resistance. The material is positioned as an alternative to silicone for applications requiring durability under high stress, available in hardness levels previously unavailable in medical-grade TPU formulations suitable for short- and long-term implants.
- 198TechnologySource · Medical Design & Outsourcing
The Quiet Revolution in Battery Technology That’s Powering Your Next Artificial Heart
Advances in lithium-ion battery technology are enabling longer operational lifespans and improved performance in implantable artificial heart devices and robotic surgical systems. The development of smart battery management systems addresses a critical supply-chain constraint for medical device OEMs relying on these power sources for next-generation cardiac support and minimally invasive tools.
- 199RegulationSource · Medical Device Network
FDA grants breakthrough status to Capitan Orthopedics’ SupraSpacer implant
The FDA granted breakthrough device designation to Capitan Orthopedics for its SupraSpacer implant, designed to treat irreparable rotator cuff tears. Breakthrough status accelerates the review pathway for devices that address unmet clinical needs and show potential advantages over existing alternatives.
- 200MarketSource · Medical Device Network
Dexcom reports 15% YoY revenue uptick in Q1 yet maintains prior FY26 outlook
Dexcom reported 15% year-over-year revenue growth in Q1 but chose not to raise its full-year FY26 guidance, citing geopolitical uncertainties. The continuous glucose monitoring vendor maintained its prior outlook despite the stronger-than-expected quarterly performance.