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
Devices
A 2/23-2/24 FDA inspection at Nihon Kohden Digital Health Solutions in Irvine, CA, determined that the firm manufactures the Next Generation NetKonnect software device, described as a patient physiological monitor device with an arrhythmia detector and alarm. A just-released 6/12 Warning Letter says the device
Drugs
FDA acting commissioner Kyle Diamantas is commenting on the traditional agency public health pillars that are being rearticulated “in a way that reflects the scientific, technological, and geopolitical reality shaping this new era of innovation as well as the future of public health.” Writing in an FDA Voices online column,
Drugs
Rep. Frank Pallone (D-NJ), the ranking member on the House Energy and Commerce Committee, has asked the Government Accountability Office (GAO) to analyze the impact of the FDA reduction-in-force (RIF) efforts through the so-called Department of Government Efficiency (DOGE) or other means on the agency’s
Devices
A 1/5-1/12 FDA inspection at ZIIP, Inc. in Pleasant Hill, CA, determined that the firm manufactures the ZIIP HALO device and the HALO 2.0, ZIIP DOT, and ZIIP Gels. A just-released 5/22 Warning Letter says all of the devices other than the original ZIIP
Drugs
Former FDAer David Gortler, who is now a Heritage Foundation senior research fellow, sees a correlation between the increasing number of drug and medical device recalls in the last few years and a change in the way the agency approaches facility inspections. Writing in an online Independent Institute news article,
Devices
A 10/30-11/19/2025 FDA inspection at the BlephEx facility in Brentwood, TN, determined that the firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVue Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVue Ophthalmic Forceps. A just-released 6/3 12-page Warning Letter lists unapproved device
Devices
FDA has approved Johnson & Johnson’s Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed field (PF) and radiofrequency (RF) energy delivery in a single device for treating cardiac arrhythmias. The platform allows electrophysiologists to switch between pulsed field and radiofrequency ablation using the same
Drugs
With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to
Devices
FDA has released the draft MDUFA Performance Goals and Procedures agreed to by CDRH and CBER under the MDUFA renewal of 2027. “Both FDA and the industry are committed to the spirit and letter of the goals described in this letter,” the document says. The specific goals and procedures are
Devices
FDA says the Abiomed 5/18 recall of certain Impella CP Sets with SmartAssist is Class 1. An agency notice says Abiomed reported that specific distributed units of Impella CP with SmartAssist do not meet design specifications. “This out-of-specification may result in low purge pressure events from the
Devices
FDA says the Insulet 5/26 recall of certain Omnipod Pods is Class 1. An agency notice says Insulet identified that some pods from specific lots may have a small tear in the cannula just above the skin, between the Pod and the point where the cannula enters the body.
Devices
A 12/1-10/10/2025 FDA inspection at 3B Medical, doing business as Reach Health, in Dublin, OH, established that BMC Medical in Beijing, China, is the specification developer and 510(k) owner of various ventilator devices that are imported into the U.S. A just-released 5/20
Devices
A 12/1-12/10/2025 FDA inspection at 3B Medical, doing business as Reach Health in Dublin, OH, found multiple violations in the firm’s manufacturing of iCodeConnect, a cloud-based software device used with continuous positive airway pressure and auto-adjusting positive airway pressure ventilator devices. A just-