Devices
A 2/6 CDRH Warning Letter to ExThera Medical Corp. said the company distributed unapproved devices to hospitals without obtaining FDA approval to do so under its open IDE. Writing in an online post, Mintz attorneys Joanna Hawana and Benjamin Zegarelli say ExThera is the sponsor of certain clinical research
Devices
FDA approved a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat adults with moderate to severe obstructive sleep apnea. The device uses proximal hypoglossal nerve stimulation, a neurostimulation approach that activates muscles controlling the airway to prevent obstruction during sleep, according to the company. LivaNova
Devices
A 2/19-3/11/2025 FDA inspection at Avertix Medical in Eatontown, NJ, found multiple violations in the firm’s manufacture of The Guardian System, an implantable coronary syndrome event detector. A just-released nine-page 9/3/2025 Warning Letter lists these Quality System Regulation violations: * failure to
Devices
Minutes from the 2/11 and 2/18 MDUFA 6 negotiating sessions between FDA and industry representatives indicate agreement was reached on several issues, with others needing further discussion. The 2/18 minutes say the two sides have agreed to proposals on patient science, digital health, third-party 510(k)
Devices
FDA has issued an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet, citing risks of improper insulin delivery. The alert applies to specific lots of the company’s Omnipod 5 Pods, a tubeless insulin delivery system used by people with diabetes. The FDA
Devices
Integra LifeSciences has recalled certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures to monitor brain pressure. The recall affects specific lots of the Codman Microsensor Basic Kit and Cerelink ICP Sensor Basic Kit, devices commonly used to measure intracranial pressure in patients
Devices
Insulet has initiated a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after identifying a manufacturing issue that could affect insulin delivery, according to an FDA notice. Some pods from specific lots may contain a small tear in the internal tubing used
Devices
FDA has approved Johnson & Johnson’s Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery, giving surgeons a new option designed to improve visual range while maintaining strong visual quality. According to Johnson & Johnson, the lens is the first FDA-approved
Devices
FDA has released a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations outlining recommendations for companies developing devices intended to support weight management or weight loss, and detailing the types of information manufacturers should include in premarket submissions. The guidance applies to several categories of
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-