Curated from medtech publications. Product launches, FDA clearances, M&A, technology shifts — rewritten as short briefs, linked back to the source. Filter by theme below.
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.
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.
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.
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.
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.
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.
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.
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.
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.