MADISON, Wis., May 6, 2025 /PRNewswire/ — The Food and Drug Administration Agency (FDA) has updated the regulatory status of Marie®, Leo Cancer Care’s upright particle therapy solution, to pending. Marie combines Leo Cancer Care’s upright patient positioning system with their upright fan beam CT scanner and can be utilized with any fixed particle beam.
The circuits could help researchers develop new treatments for fragile X syndrome and other diseases caused by mutations of a single gene.
Innovative mesh aims to improve patient outcomes by naturally absorbing into the body post-surgery.
Novocure (Baar, Switzerland) announced today that it has won a CE mark for its Optune Lua wearable device for treating metastatic non-small cell lung cancer.
ICU Medical (Nasdaq: ICUI) announced today that it received FDA 510(k) clearance for several new additions to its infusion pump portfolio.
Resmed (NYSE: RMD)+
announced today that it launched its NightOwl home sleep apnea test across the U.S.
U-Pump announced on social media that it reached a new milestone in its development of an AI-powered, reusable insulin patch pump.
SCOTTSDALE, Ariz., March 20, 2025 /PRNewswire/ — Anuncia Medical, Inc. (“Anuncia”), a pioneering company in CSF management and neurocritical care, has received Breakthrough Device Designation from the FDA for its ReFlow® EVD, an innovative solution for external ventricular drains (EVDs) used to manage brain swelling and elevated intracranial pressure.
FRANKLIN LAKES, N.J., March 20, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD’s efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.
Medtronic (NYSE:MDT) today announced real-world data supporting the use of its smart insulin pen and CGM sensor combination.