Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens. Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected […]
FDA
Imagen Technologies wins FDA nod for computer-assisted detection device
Imagen Technologies announced today that the FDA cleared its computer-assisted detection (CADe) device, Aorta-CAD. New York-based Imagen designed Aorta-CAD to assist physicians in detecting findings on chest X-rays. Those findings may suggest the prevalence of aortic atherosclerosis and aortic ectasia. The cloud-based, software-only medical device uses deep learning to detect and highlight its findings. According […]
FDA clears mixed reality surgical planning tool from apoQlar
apoQlar announced today that it received FDA 510(k) clearance for its VSI HoloMedicine mixed reality software for surgeons. Hamburg, Germany-based apoQlar designed VSI HoloMedicine to enable surgeons to plan complex procedures with 3D holographic technology. According to a news release, FDA clearance makes the U.S. the 30th country to clear the apoQlar technology. The company […]
Enovis wins FDA nod for patient-specific Star Ankle instrumentation
Enovis (NYSE:ENOV) announced today that the FDA approved the STAR patient-specific instrumentation for use with the STAR total ankle replacement system. Wilmington, Delaware–based Enovis designed the STAR PSI system to provide a personalized preoperative plan for each patient. Surgeons receive and review a 3D visualization of the patient’s ankle joint. This includes information about existing […]
FDA clears next-gen hemostasis system from HemoSonics
HemoSonics announced today that it received FDA 510(k) clearance for its Quantra hemostasis system with the QStat cartridge. FDA clearance expands the Quantra system’s indications to include trauma and liver transplantation procedures. Durham, North Carolina-based HemoSonics designed the next-generation system to increase Quanta’s overall diagnostic capabilities. It covers the broadest range of indications of any […]
Electromed wins FDA clearance for next-gen airway clearance generator
Electromed (NYSE:ELMD) announced today that it received FDA 510(k) clearance for its SmartVest Clearway airway clearance system. New Prague, Minnesota-based Electromed designed the system for high-frequency chest wall oscillation (HFCWO) therapy. It represents the fifth generation of Electromed’s technology. According to a news release, the updated approach to HFCWO offers an enhanced patient experience with […]
Baxter’s smart incontinence pad recall is Class I
The FDA issued a notice declaring the Baxter (NYSE:BAX) WatchCare incontinence management system (IMS) recall as Class I, the most serious kind. Baxter last month issued an urgent medical device correction for the WatchCare IMS. The system appears to radiate radiofrequency (RF) that may affect other devices on caregivers and patients. The list of potentially […]
Zimmer Biomet’s 3D-printed tibia receives FDA clearance
Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for the Persona OsseoTi keel tibia. Warsaw, Indiana-based Zimmer Biomet designed the system for cementless knee replacement. It represents the latest addition to the Persona Knee system platform. Persona OsseoTi features a new porous version of the Persona anatomic tibia. It includes the Zimmer […]
FDA clears Neocis surgical robot for bone reduction
Neocis announced today that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction. This represents the second FDA clearance for Neocis this year, and its 14th in total. Miami-based Neocis designed its Yomi surgical robot for dental surgery. It assists clinicians in the planning and operative phases […]
EndoStim wins FDA breakthrough designation for EndoStim to treat drug-refractory GERD
EndoStim announced that it received FDA breakthrough device designation for its neurostimulation system for treating GERD. Santa Ana, California-based EndoStim designed its system to treat drug-refractory gastroesophageal reflux disease (GERD). The disease affects the ring of muscle between the esophagus and the stomach, the lower esophageal sphincter (LES). It causes stomach acid to repeatedly flow […]
FDA proposes updates to Breakthrough Devices Program guidance
Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance. Once finalized, the guidance document updates would expand the Breakthrough Devices Program’s scope to include devices that will improve accessibility and promote health equity. Specifically, the draft guidance clarifies the considerations […]