Devices
FDA has issued an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious injury or death if the devices are not updated. The action affects several ventilator models in the Trilogy Evo platform, including the Trilogy Evo, Trilogy EV300, Trilogy
Devices
Researchers from several universities say that low use of predetermined change control plans (PCCPs) for AI-enabled medical devices could be a missed opportunity for improving device performance. The researchers report on a cross-sectional study describing PCCP use among AI-enabled medical devices and the comprehensiveness of public reporting
Devices
FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators, according to a new legal analysis from Cooley LLP examining the recent criminal enforcement action against medical device maker ExThera Medical Corporation and one of its former executives (see earlier story). Former
Devices
Senator Tom Cotton (R-AR) is pressing FDA and government cybersecurity officials to review Chinese-made medical devices cleared before updated cybersecurity requirements took effect, citing concerns that vulnerable devices could expose Americans to espionage, fraud and potentially dangerous remote manipulation. In a 5/26 letter to acting FDA commissioner
FDA Policy/General
The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact. Written by staff and a student at the
Devices
FDA has issued an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by Abiomed that could temporarily stop circulatory support during treatment. The agency says Abiomed has initiated an urgent medical device correction affecting all Automated Impella Controllers used with left ventricular Impella
Devices
React Health is recalling (Class 1) certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause serious injury or death, according to an FDA notice. The recall affects VOCSN V+Pro Package devices with catalog number PRT-01198-000 and
Devices
FDA says the Bolton Medical 8/23 recall (correction) notice, with updated use instructions for all RelayPro Thoracic Stent Graft Systems, is a Class 1 recall, the most serious type of medical device recall. An agency notice says the company also recommended that customers use alternative stent-graft options before
Devices
Implantica says it has submitted the final response to FDA on its PMA for RefluxStop that addresses the agency’s remaining questions tied to Module 3 of the submission and includes additional testing that followed a previously disclosed 100-Day Meeting. Implantica said the FDA has now completed reviews of
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