MedTech News
Boston Scientific obtains CE Mark for ACURATE Prime Aortic Valve System
The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis.
Biocoat Incorporated Secures New Patent for Non-PFAS Inner Diameter Coating
HORSHAM, Pa., Aug. 27, 2024 /PRNewswire/ — Biocoat Incorporated, a leader in the development, manufacturing, and application of hydrophilic coatings for medical devices, is proud to announce the issuance of a patent for “Lumen Coating Method and Apparatus.” This new patent covers a groundbreaking thermal cure hydrophilic coating technology specifically designed for application to the lumen, or inner diameter. This technology is commonly applied in catheters and other medical devices used in multiple medical specialties, including cardiology and neurology.
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).