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
FDA clears DermaSensor AI-powered skin cancer detection device
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system. Miami-based DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound. […]
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. […]
FDA approves Zeiss software that treats nearsightedness
Zeiss Medical Technology announced that the FDA approved the VisuMax 800 with Smile Pro software. The Carl Zeiss Meditec unit designed the software to treat nearsightedness, with or without astigmatism. Its latest generation of femtosecond lasers enters the U.S. market with more than 8 million eyes already treated with Smile software. “The increasing global adoption […]
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 […]
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. […]
FDA clears next-gen handheld ultrasound from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%. The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- […]
SimBioSys wins FDA nod for TumorSight precision medicine platform
SimBioSys announced that it received FDA 510(k) clearance for its TumorSight cloud-based digital precision medicine platform. FDA clearance came just days after the company inked a partnership with Mayo Clinic to develop precision medicine solutions. The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides […]
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]