Abbott announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system. Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine. Abbott says four […]
Food & Drug Administration (FDA)
FDA warns on defective packaging with Exactech shoulder system
The FDA issued a warning related to possible health risks associated with the Exactech Equinoxe shoulder system joint replacement devices. Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue […]
FDA clears stereotactic guidance system from ClearPoint Neuro
ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
ResMed CPAP masks recall is Class I
The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality. The Zeta cranial navigation system’s special clearance applies to enhanced software features and compatibility with additional accessories. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September. The Zeta cranial navigation system provides surgeons with GPS-like […]
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It […]
Megadyne Medical recall of patient return electrodes is Class I
The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind. This action is a correction, not a product removal. Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. […]
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
Insulet has a Class I recall for the Omnipod 5 Android App
The FDA labeled a recall of the Insulet Omnipod 5 App for Android smartphones as Class I, the most serious kind. Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. […]