MedTech News
Abbott launches Lingo over-the-counter CGM biosensor in the U.S.
Abbott (NYSE: ABT)+
today announced a major product launch, broadening the population that can utilize its continuous glucose monitoring (CGM) technology.
First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance
CENTER VALLEY, Pa., Sept. 5, 2024 /PRNewswire/ — Odin Medical Ltd., an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first cloud-based Artificial Intelligence (AI) technology designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures, the CADDIE™ computer-aided detection (CADe) device.
THINK Surgical Receives FDA 510(k) Clearance for Zimmer Biomet Persona Knee on TMINI® Miniature Robotic System
FREMONT, Calif., Sept. 5, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the Persona® The Personalized Knee System® from Zimmer Biomet.
Fresenius Medical Care launches new home hemodialysis system
Fresenius Medical Care announced today that it launched the newest version of its home hemodialysis (HHD) machine, the NxStage Versi HD with GuideMe software.
Medtronic earns FDA approval for expanded MRI labelling
The new MRI labelling extends the active scan time for Medtronic DBS systems.
Vesalio launches pVasc Thrombectomy System in the U.S. for peripheral occlusions
PLANO, Texas, Sept. 4, 2024 /PRNewswire/ — Vesalio announces the U.S. commercialization of pVasc™ Thrombectomy System for non-surgically removing peripheral occlusions. pVasc targets the full range of embolisms from soft, acute clots to fibrin-rich, calcified ones, enabling a fast and safe removal. Its unique Drop Zone™ technology traps, retains and securely removes thrombus to restore flow in patients suffering from acute limb ischemia (ALI) and other conditions related to peripheral artery disease (PAD).
US FDA Grants Clearance for DaylightRx
SAN FRANCISCO, Sept. 4, 2024 /PRNewswire/ — Big Health, a leading developer of digital mental health treatments, has been granted clearance by the U.S. Food and Drug Administration (FDA) for its digital therapeutic, DaylightRx. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient’s GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
AngioDynamics wins CE mark for atherectomy system
AngioDynamics (Nasdaq:ANGO) announced today that it received CE mark approval for its Auryon atherectomy system.