Regulation — older stories
135 stories beyond the latest 40.
- 161RegulationSource · 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.
- 162RegulationSource · 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.
- 163RegulationSource · 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.
- 164RegulationSource · 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.
- 165RegulationSource · 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.
- 166RegulationSource · 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.
- 167RegulationSource · 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.
- 168RegulationSource · 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.
- 169RegulationSource · 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.
- 170RegulationSource · 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.
- 171RegulationSource · 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.
- 172RegulationSource · 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.
- 173RegulationSource · 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.
- 174RegulationSource · 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.
- 175RegulationSource · 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.