Devices
Mosaic Clinical Technologies is petitioning FDA to clarify the regulatory status of commercially available artificial intelligence vision language models (VLMs). The petition says VLMs perform medical image analysis to support diagnosis and treatment and ensure consistent application of medical device requirements to these tools. “The safety and effectiveness of these
Devices
FDA is soliciting stakeholder feedback on a discussion paper outlining considerations for regulating AI-enabled medical devices. The paper says generative artificial intelligence (GenAI)-enabled medical devices “hold transformative promise for patient care and the broader health ecosystem.” It also says such devices may introduce unique risks when compared to
Devices
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip
Devices
On behalf of FDA, the Justice Department has asked the Nevada federal court to issue an injunction to stop Steiner Biotechnology from manufacturing and selling adulterated and misbranded dental products. A department media statement says FDA inspected the Steiner manufacturing facility at least four times from 2018 to 2025, finding
Devices
An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold. Hamilton Medical says that certain lots of coaxial breathing circuit sets preassembled with
Devices
FDA is announcing a 9/23 meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to vote on a Grail PMA for the Galleri test. The test is described as a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect
Devices
AdvaMed says it strongly supports the draft MDUFA 6 agreement. Speaking at an FDA public hearing, association executive vice president for digital and diagnostics technologies Zach Rothstein said the commitment “builds on what is working, makes practical improvements where they are needed, and prepares the program for the technologies FDA
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a founding member, has published a final document outlining global principles for Predetermined Change Control Plans (PCCPs), a regulatory approach intended to streamline updates to medical device software while maintaining safety and regulatory oversight. The “Essential Principles and Content
Devices
FDA has issued an early alert warning healthcare providers not to use certain Becton Dickinson (BD) intraosseous vascular access needle sets after the company identified a manufacturing defect that has been linked to delays in establishing emergency vascular access, including reports of four deaths and 45 serious injuries. The alert
Devices
A 2/2-2/6 FDA inspection at Koven Technologies in St. Louis, MO, found Quality Management System Regulation (QSMR) violations in the firm’s production and/or marketing of the Bidop 3 Doppler. A just-released 7/21 Warning Letter lists these violations: * failure to document procedures to control
Devices
FDA has issued an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices,” which describes current recommendations for applying human factors and usability engineering during the design and development of medical devices, revising a 2016 document to reflect changes in quality system requirements and current regulatory
Devices
Resmed has recalled (Class 1) its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembly that may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy. An FDA notice says the agency determined the
Devices
FDA has granted de novo authorization for Caristo Diagnostics’ CaRi-Heart, described by the company as the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography. A company statement says it will begin the CaRi-Heart commercial launch this quarter and
Devices
A 2/4-3/6 FDA inspection at the Linemaster Switch Corp. facility in Woodstock, CT, found Quality System Regulation violations in the firm’s manufacturing of foot pedal accessories for medical devices. A just-released 5/3 Warning Letter says the specific violations were: * failure to perform rework following
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus), following reports that the arterial sheath tip can separate during use. The agency said
Drugs
Attorney Megan Robertson (Epstein Becker Green) says the biggest trend in FDA Warning Letters so far this year has been the agency’s crackdown against online telehealth platforms that offer compounded GLP-1 drugs. Appearing in a brief video, Robertson says FDA’s push is for the companies to clean
Devices
A new citizen petition is urging FDA to establish a regulatory framework for implantable brain-computer interfaces (BCIs) designed to expand human sensory perception beyond the natural limits of human vision. The just-posted petition, filed by Ali Afshar of Age Reversal Unity in New York, asks FDA to develop
Devices
FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking the launch of a joint FDA-CMS initiative designed to evaluate digital health technologies using real-world evidence while expanding access to innovative care for patients with
Devices
FDA and medical device industry representatives have reached an agreement in principle on MDUFA 6 and have turned to writing the draft commitment letter to operationalize the agreement. Attorney Jake Leys (Gardner) writes in an online post that the agreement will cover the 2028-2032 fiscal years (see performance goals)
Devices
FDA has issued an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could allow air to enter a patient's intravenous line under specific conditions. The agency said Baxter has notified affected customers and is recommending that certain
Devices
FDA has classified as Class 1 a Bolton Medical recall of its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death. The company recently issued a device removal notice on specific device configurations, instructing healthcare providers to immediately
Devices
A Minnesota federal judge has ruled in favor of FDA and Medtronic in three of four spinal cord stimulator (SCS) lawsuits. MassDevice reports online that the suits claimed that the Medtronic SCS systems implanted in four patients caused damage. The judge ruled that all claims from three of the four