MedTech News
.................... by Andrew Celentano
FDA Grants Aesculap Breakthrough Device Designation for the M.scio® Non-Invasive Telemetric Pressure Measurement System
CENTER VALLEY, Pa., Aug. 27, 2024 /PRNewswire/ — Aesculap, Inc. (Aesculap), in partnership with Christoph Miethke GmbH & Co. KG (MIETHKE), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the M.scio® System. This unique, non-invasive, telemetric pressure measurement system is designed to provide continuous access to long-term, intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) for the management of hydrocephalus via a permanent, fully implantable sensor.
Accuray wins CE mark for new helical radiation delivery system
Accuray (Nasdaq: ARAY)+
announced today that it received CE mark approval for its Helix CT-guided helical radiotherapy system.
Stimvia plans to enter neuromodulation market in the USA after MDR certification
The Czech company says this is the first non-invasive closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs.
Dexcom launches Stelo over-the-counter CGM
Dexcom (Nasdaq: DXCM)+
today announced a significant product launch as another continuous glucose monitor (CGM) is hitting the market.
Clearmind Biomedical wins FDA clearance for Neuroblade minimally invasive neuroendoscopy tech
Clearmind Biomedical announced today that it received FDA 510(k) clearance for its Neuroblade neuroendoscopy system.
OBVIUS Robotics™ Receives U.S. FDA Breakthrough Device Designation for CERTA™ Access System for Central Venous Catheterization
SUNRISE, Fla., Aug. 26, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its CERTA Access System for central venous catheterization (CVC).
Insulet expands Omnipod 5 pump to people with Type 2 diabetes
The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.
Olympus Launches New POWERSEAL™ Sealer/Divider 5mm Devices, Extends Advanced Bipolar Surgical Energy Portfolio
WESTBOROUGH, Mass., Aug. 26, 2024 /PRNewswire/ — Olympus Corporation, a global medical technology company committed to making people’s lives healthier, safer, and more fulfilling, announced today the launch of two new jaw designs in the POWERSEAL™ Sealer/Divider family of advanced bipolar surgical energy products: the POWERSEAL Straight Jaw, Double-action (SJDA) and the POWERSEAL Curved Jaw, Single-action (CJSA). The first POWERSEAL device, launched in 2021, is the POWERSEAL Curved Jaw, Double-action (CJDA), which has established a strong foothold for Olympus in the advanced bipolar surgical energy market.