Regulation — older stories
26 stories beyond the latest 40.
- 041RegulationSource · 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.
- 042RegulationSource · 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.
- 043RegulationSource · 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.
- 044RegulationSource · 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.
- 045RegulationSource · 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.
- 046RegulationSource · 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.
- 047RegulationSource · 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.
- 048RegulationSource · 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.
- 049RegulationSource · 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.
- 050RegulationSource · 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.
- 051RegulationSource · 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.
- 052RegulationSource · Medical Device Network
enVVeno Medical secures FDA IDE approval for venous valve study
enVVeno Medical received FDA Investigational Device Exemption (IDE) approval to proceed with a pivotal clinical study of its non-surgical venous valve replacement device. IDE approval permits the company to begin human testing as part of the pathway toward broader regulatory clearance.
- 053RegulationSource · MedCity News
Why Some Hospitals Won’t Be Able to Comply With Upcoming HIPAA Updates
The first major HIPAA update in over a decade will eliminate the distinction between required and addressable safeguards, making key cybersecurity and physical security measures mandatory for all healthcare providers. The shift is expected to expose gaps in hospitals' fragmented security systems, according to cybersecurity platform leaders.
- 054RegulationSource · Medical Device Network
Medtronic receives CE mark for Stealth surgical platform
Medtronic received CE mark approval for its Stealth AXiS surgical platform, an integrated system that combines preoperative planning, intraoperative navigation, and robotic guidance capabilities. The clearance enables commercial distribution in European markets.
- 055RegulationSource · Medical Device Network
FDA approves Avatar Medical’s 3D image processing software
Avatar Medical received FDA approval for its 3D image processing software, which converts CT and MR imaging data into three-dimensional models to support surgical planning and OR workflow optimization. The software integrates imaging data to enhance preoperative visualization for surgical teams.
- 056RegulationSource · Medical Device Network
Abbott secures FDA approval for Ultreon 3.0 imaging platform
Abbott received FDA approval and CE Mark for Ultreon 3.0, an AI-powered coronary imaging platform. The clearance enables the company to market the system in the US and European Union for intravascular imaging and analysis applications.
- 057RegulationSource · Medical Device Network
FDA and CMS outline new Medicare coverage pathway for medical device access
The FDA and CMS announced a new pathway designed to accelerate Medicare coverage decisions for medical devices following FDA approval. The initiative aims to streamline the process between regulatory clearance and reimbursement eligibility, reducing the time gap that typically delays device access to Medicare beneficiaries.
- 058RegulationSource · Medical Design & Outsourcing
FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices
The FDA and CMS jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, a new accelerated Medicare coverage mechanism designed to synchronize FDA market authorization with CMS National Coverage Determinations. The initiative aims to reduce delays and streamline reimbursement access for breakthrough medical devices.
- 059RegulationSource · Medical Device Network
J&J secures CE mark for ETHICON 4000 Stapler
Johnson & Johnson obtained CE mark approval for the ETHICON 4000 Stapler, a surgical stapling device designed to maintain staple line integrity across variable tissue thicknesses. The clearance enables commercial distribution in European markets.
- 060RegulationSource · Medical Device Network
FDA grants clearance for Philips’ Rembra scanning platform
Philips received FDA 510(k) clearance for its Rembra platform of scanning systems, which includes the Rembra CT, Rembra RT, and Areta RT models. The clearance enables the vendor to market these imaging devices in the United States.
- 061RegulationSource · Medical Design & Outsourcing
Trelleborg Costa Rica site earns ISO 13485 certification
Trelleborg Medical Solutions' manufacturing facility in Costa Rica has achieved ISO 13485:2016 certification, the international quality management standard for medical device design and manufacturing. The certification demonstrates the site's compliance with process controls and risk management requirements for medical device production.
- 062RegulationSource · Medical Design & Outsourcing
FDA warns device manufacturers of nitrosamine impurities that could cause cancer
The FDA Center for Devices and Radiological Health issued a warning to manufacturers of drug-device combination products alerting them to potential nitrosamine impurities, which are classified as probable carcinogens. The agency did not specify which device types or manufacturers are affected in the letter, but advised vigilance on contamination risks during manufacturing and sourcing of raw materials and components.
- 063RegulationSource · Medical Device Network
Xeltis gains EU CE mark on positive trial data for vascular access graft
Xeltis obtained CE mark approval in the EU for its aXess vascular access graft following positive pivotal trial results. The trial demonstrated 79% secondary patency and 1.3 patency-related reinterventions per patient year, meeting regulatory benchmarks for the hemodialysis access device.
- 064RegulationSource · Medical Design & Outsourcing
PSN Manufacturing earns ISO 9001 and 13485 certifications
PSN Manufacturing, a contract manufacturer of precision components and sub-assemblies for medical devices, has achieved ISO 9001:2015 and ISO 13485:2016 certifications. The dual certifications validate the company's quality management systems and regulatory compliance capabilities, positioning it to serve as a certified contract development and manufacturing organization (CDMO) for medical device suppliers.
- 065RegulationSource · Medical Design & Outsourcing
Regulatory tips from a breakthrough noninvasive device startup
Compremium's Quantis CVP, a noninvasive central venous pressure measurement device, received FDA Breakthrough Device designation in January 2026 and was enrolled in the FDA's Total Product Life Cycle Advisory Program (TAP). The program provides regulatory guidance to accelerate development of high-priority medical devices. The designation and TAP enrollment support expedited patient access pathways for the device.
- 066RegulationSource · Fierce Healthcare
FDA clears first AI tool for breast cancer risk prediction from startup Clairity
The FDA cleared Clairity's AI tool for predicting five-year breast cancer risk from routine mammograms, marking the first FDA-cleared application of this kind. The software analyzes screening mammograms to generate individualized risk assessments, enabling radiologists and clinicians to tailor follow-up protocols and patient management strategies based on quantified risk levels.