Devices
A patient safety group has petitioned FDA urging it to rescind or narrow a recent device clearance that allows use of a robotic surgical system in nipple-sparing mastectomy procedures, arguing that long-term cancer outcomes have not been established. The petition asks the agency to immediately amend or withdraw
Drugs
The Sedgwick Recall Index says there were 978 medical device recalls in 2025 involving 490.23 million units. The report says that was fewer recalls but more units than in 2024 (1,059 events and 440.41 million units). The total number of recalled units in 2025 was the highest
Devices
An FDA Early Alert says the agency is aware that Trividia Health has issued an urgent medical device correction for updated use instructions for four models of its True Metrix blood glucose monitors. The alert says the company is correcting the E-5 error code in the Messages section of
Biologics
The Senate HELP Committee has released a report with 15 recommendations for reforming FDA. The report says innovation in medical care and treatment is meaningless unless it creates products that actually help patients. “Discoveries that never leave the lab help no one,” it declares. “FDA has enormous leverage over how
Devices
As part of FDA’s recent implementation of the Quality Management System Regulation (QMSR), a new risk-based inspection model is set to change medical device oversight. The updated framework is detailed in the agency’s revised Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850) and applies
Devices
Medline has recalled (Class 1 device correction) certain Medline homecare beds, warning that continued use without updated instructions could result in serious injury or death. The action affects multiple models of Medline Basic and Medlite Homecare Beds. An FDA recall notice says Medline has received reports of pendants overheating, sparking,
Devices
FDA has approved Novocure’s Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer, marking the first new FDA-approved treatment for this setting in nearly three decades. The approval is based on data from the Phase 3 PANOVA-3 trial,
Devices
A detailed report published by the Reuters news service says FDA is receiving an increasing number of complaints about patient injuries during surgeries involving medical devices that use artificial intelligence (AI). Much of the report (paywall) discusses the Acclarent TruDI navigation system that is used to show doctors where their
Devices
Minutes from the 1/21 MDUFA 6 reauthorization meeting indicate progress is being made in several areas. The minutes say industry representatives gave their feedback on real-world evidence (RWE), saying they support the National Evaluation System for Health Technology (NEST) and emphasizing that NEST Mark is potentially an important
Devices
FDA has cleared a Median Technologies 510(k) for eyonis LCS, the first artificial intelligence (AI)–based device cleared for both detection and diagnosis in lung cancer screening. The software-as-a-medical-device is designed to help clinicians identify lung cancer at earlier, potentially curable stages while reducing false
Devices
Johnson & Johnson MedTech has recalled (Class 1) multiple versions of its Cerepak Detachable Coil System, which is manufactured by subsidiary Cerenovus, for treating intracranial aneurysms and other neurovascular conditions. An FDA recall notice says the devices are being removed from hospitals and other points of use after the manufacturer
Devices
FDA has published a guidance, Computer Software Assurance for Production and Quality Management System Software, to supplement an earlier guidance on General Principles of Software Validation. The new document contains recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or
Devices
A 10/20-10/30/2025 FDA inspection at the Flextronics America facility in Austin, TX, found Quality System Regulation violations in the firm’s manufacturing of a continuous glucose monitor. A 1/27 Warning Letter says the specific violations were: * failure to adequately ensure that when the results of
Devices
Three Hogan Lovells attorneys say FDA’s new medical device inspection protocol that aligns with the new Quality Management System Regulation will require device manufacturers to prepare for a significant operational and cultural transformation for undergoing, addressing, and responding to inspections and remote regulatory assessments. Writing in an online post,
Devices
FDA has classified Abbott Diabetes Care’s recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I recall, the agency’s most serious designation, warning that continued use could cause serious injury or death. The recall involves specific lots of the
Devices
Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the procedure, has passed away at the age of 88 in a hospital in Madison, WI. His wife, Carolyn Zahn-Waxler,
Devices
An FDA review of records submitted at the agency’s request by Unomedical Device in Reynosa, Tamaulipas, Mexico, identified Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of infusion sets for subcutaneous insulin delivery in diabetic patients. A just-released 1/8 Warning Letter says
Devices
A 10/14-10/23/2025 FDA inspection at the Abbott Diabetes Care facility in Alameda, CA, found Quality System Regulation violations in the firm’s manufacturing of flash and continuous glucose monitoring systems. A 1/23 Warning Letter says the specific violations were: * failure to adequately establish and maintain
Devices
FDA has issued an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients with acute right heart failure. The alert, which applies to all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, comes after Abiomed
Devices
FDA has issued Beta Bionics a Warning Letter following an inspection of the company’s Irvine, CA, facility conducted 6/2025, according to a company regulatory filing. The agency issued the letter 1/29 after reviewing the company’s responses to a Form 483 listing inspectional observations identified during the
Devices
A patient safety advocacy group has filed a citizen petition urging FDA to create a comprehensive public database of medical device labels, arguing that greater transparency is needed to support informed decision-making, research, and postmarket oversight. The petition asks the agency to publicly post all labels, labeling, and instructions
Devices
On 2/2, FDA is discontinuing the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). FDA will also no longer use Inspection of Medical Device