Devices
A 715-7/25/2025 FDA inspection at the Exactech Inc. facility in Sarasota, FL, doing business as Advita Ortho, identified seven Quality System Regulation violations in the firm’s manufacturing of accessories for the Equinoxe Reverse Shoulder System. A just-released 12/19/2025 Warning Letter says the specific
Devices
FDA has issued an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that some devices may rupture during use. FDA says Erbe USA has advised customers to remove specific Flexible Cryoprobes from use or sale. The devices are used to destroy tissue through
Devices
FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has been classified as Class 1, warning that the devices could cause serious injury or death if used. The recall affects several catheters distributed through Medline’s ReNewal reprocessing program, including models originally manufactured by
Devices
Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDA’s new inspection approach for medical device manufacturers under the Quality Management System Regulation and discuss key changes from prior inspection methods. The attorneys note that the updated regulatory framework signals a shift toward
Devices
The former chief regulatory officer at medical technology company ExThera Medical Corp. has been charged with concealing serious adverse events — including two patient deaths — from FDA in connection with a blood filtration device used on cancer patients treated outside the U.S., federal prosecutors said 3/5. The U.S.
Devices
A petition submitted by Harmed Americans for Reform in Medical Device Safety (HARM) calls on FDA to investigate Mayo Clinic's promotion and use of robotic nipple-sparing mastectomy using a da Vinci surgical system. The petition says Mayo is using the robotic system outside the ongoing IDE. It
Devices
A 7/21-8/19/2025 FDA inspection at Diasol, Inc., in Phoenix, AZ, found that the company is manufacturing unapproved disinfectants used to disinfect dialysate delivery systems and water purification systems used in hemodialysis to treat patients with renal failures or toxemic conditions. A just-released 1/29 Warning
Devices
FDA has approved a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc indicated for single-level use between C3 and C7. The approval allows the device to be marketed for patients with degenerative disc disease (DDD) of the cervical spine requiring replacement at one
Devices
FDA has issued an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, warning that a malfunction could lead to pump failure and patient death. The alert concerns specific Generation 1 Impella Purge Cassettes and Impella RP Pump Sets used with the company’
Devices
Fresenius Kabi has recalled (Class 1 device correction) its Ivenix Large Volume Pump due to a software issue. The recall applies to the Ivenix devices version 5.10.1 and earlier. Fresenius has instructed customers to update to software version 5.10.2 as soon as possible. According to an
Devices
The medical device industry is urging federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient care, warning that new or duplicative regulatory frameworks could slow innovation and delay access to AI-enabled technologies. In a comment letter responding to a federal
Devices
Olympus has recalled (Class 1) its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death. An agency notice says a software algorithm in the devices requires correction to address a potential issue that could result in overpressure events during use. Because no
Devices
FDA has accepted a Sibel Health Letter of Intent for its Aria cough monitor into the Clinical Outcome Assessment Qualification Program under the Drug Development Tool framework. A company statement says the Aria sensor adheres directly to the suprasternal notch at the base of the neck and uses advanced acousto-
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