Devices
FDA has granted Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test, an artificial intelligence-powered digital pathology tool designed to help predict outcomes for bladder cancer patients. The company says the test is designed for use in patients with non-muscle-invasive bladder cancer,
Devices
FDA has approved Guardant Health’s next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed to provide both genomic and epigenomic insights for patients with advanced cancer. The company says the newly approved assay replaces the earlier Guardant360 CDx platform and transfers all seven previously approved
Devices
FDA has published frequently asked questions about the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot project, which it has launched with the Centers for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. The document says the TEMPO pilot aims to: * promote access to certain
Devices
The FDA breakthrough medical device program is growing, and the agency should consider additional staff and resources to keep up with oversight of medical device recalls as recommended in a 2025 Government Accountability Office report. That’s the recommendation of Stanford Law School Center for Law and the Biosciences fellow
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk problem involving certain anesthesia workstations manufactured by Drager that could cause mechanical ventilation failure during use. The alert affects the company’s Atlan A350 and Atlan A350 XL anesthesia workstations, which are used during surgical and
Devices
A newly filed citizen petition is urging FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say is being marketed and used in the U.S. without FDA authorization. The device, which is manufactured by Advanced Bariatric, is described as a reversible, non-cutting alternative
Devices
Boston Scientific has begun a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy pacemakers (CRTP) following reports of device malfunctions linked to four deaths and more than 2,500 injuries. The action affects multiple models in the Accolade Family of Implantable Pacemakers and CRTP devices, including
Devices
FDA has released new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic implant procedures, as the agency seeks to standardize a rapidly evolving category of medical devices. The document, titled “Patient-Matched Guides for Orthopedic Implants,” reflects FDA’s current thinking
Devices
A 9/19-12/4/2025 FDA inspection at the Unetixs Vascular facility in Warwick, RI, determined that the firm is illegally selling adulterated and misbranded vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. A 4/15 Warning Letter says the devices are adulterated because the firm does
Devices
Initial FDA Quality Management System Regulation (QMSR) investigations have shown that agency investigators are likely to verify that connections between complaint handling, unique device identifier assignment and documentation, and post-market surveillance activities are adequately addressed. An online Quality Magazine article says dual compliance is also an inspection focus area,
Devices
FDA and CMS have announced a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patients, part of a broader push to streamline regulation and expand access to emerging technologies. The newly created Regulatory Alignment for Predictable and Immediate Device (RAPID)
Devices
Three advocacy groups — Consumers for Dental Choice, Alliance of Nurses for Healthy Environments, and Mercury Policy Project — are petitioning FDA to ban mercury amalgam dental fillings. The 4/16 petition specifically asks the agency to: * ban dental amalgam; * ban the use of dental amalgam at least in high-risk populations,
Devices
FDA has rejected a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure system, concluding the medical device remains safe, effective and appropriately regulated under existing law. In a detailed response, the agency said the petition failed to provide sufficient scientific or legal grounds to revoke the
Devices
FDA has cleared a Philips 510(k) for its new Spectral CT Verida system, marking the U.S. debut of what the company describes as the first AI-powered detector-based spectral CT scanner. The device integrates always-on spectral imaging with artificial intelligence – driven image reconstruction, aiming to improve
Devices
AdvaMed says it supports FDA’s effort to implement the 21st Century Cures Act by appropriately expanding exemptions from premarket notification for Class 2 devices where a 510(k) submission is not necessary to provide reasonable assurance of safety and effectiveness. In a comment letter, the industry trade association: * says
Devices
A 4/1 CDRH Town Hall reviewed the new Quality Management System Regulation (QSMR) and its associated Compliance Program for medical device risk-based inspections. Office of Medical Devices and Radiological Health Inspectorate senior advisor Karen Masley-Joseph described the QMSR program that became effective 2/2. She said the
Devices
While many elements of QMSR (Quality Management System Regulation) inspections will feel familiar, the shift as of the 2/2 compliance date toward evaluating the entire Quality Management System (QMS), the increased emphasis on risk management integration, and the broader discretion afforded to investigators “represent meaningful changes that manufacturers should
Devices
FDA has issued an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical, warning healthcare providers to stop using the devices and return affected products. Sizing catheters are commonly used in angiographic procedures to help clinicians measure and navigate blood vessels. The agency says
Devices
FDA and the medical device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations, according to a MedTech Dive report. Both sides have reached an “agreement in principle” on most elements of the deal and are now working to finalize
Devices
Medline Industries has recalled (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death. The recall affects Namic Angiographic Rotating Adaptor Control Syringes and related convenience kits, which are used to deliver contrast media during imaging procedures. The company has instructed customers to immediately remove
Devices
A 12/1-12/12/2025 FDA inspection at the Medline Industries NAMIC Division facility in Glens Falls, NY, found Quality System Regulation violations in the firm’s manufacturing and assembly of numerous medical devices into cardiovascular procedure kits. A 3/25 Warning Letter says the specific violations were: * failure
Devices
FDA has opened the selection phase of its Reducing Readmissions through Device Innovation for the Home (READI-Home) innovation challenge, which is intended to accelerate patient access to medical device technologies aimed at reducing hospital readmissions. An agency post invites innovators to pursue potential participation in the challenge by providing