MedTech News
FDA authorizes sleep wearable algorithm updates from Beacon Biosignals
Beacon Biosignals announced today that it received FDA authorization for a new update to its Dreem 3S wearable sleep monitoring headband.
FastWave Medical secures sixth patent for IVL portfolio
FastWave Medical today announced the sixth U.S. utility patent for its laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease.
An inflatable gastric balloon could help people lose weight
The new balloon can be expanded before a meal to prevent overeating, then deflated when no longer needed.
FDA clears Nonin’s Tru02 over-the-counter fingertip pulse oximeter
Nonin Medical has won FDA 510(k) clearance for its first over-the-counter fingertip pulse oximeter, the TruO2 OTC.
MENTOR™ MemoryGel™ Enhance Breast Implant Receives FDA Approval for Largest Size Breast Implants for Reconstruction
IRVINE, Calif., Dec. 2, 2024 /PRNewswire/ — Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of Johnson & Johnson MedTech, today announced the U.S. Food and Drug Administration (FDA) approved MENTOR™ MemoryGel™ Enhance Breast Implants for primary and revision reconstruction breast surgery in post-mastectomy women.
Transpara Announces New FDA Clearance Designed to Improve Breast Cancer Detection at RSNA
CHICAGO, Dec. 2, 2024 /PRNewswire/ — ScreenPoint Medical is showcasing a new FDA clearance for innovative new capabilities of its industry leading Breast AI Transpara here at the 110th Annual Radiological Society of North America (RSNA) meeting, December 1-4, 2024 (South Hall #5316)
Bracco Diagnostics Inc. Branded Max 3™, a Rapid Exchange and Syringeless Injector, received FDA 510(k) clearance adding evolving innovation in Magnetic Resonance Imaging (MRI) and its product portfolio
PRINCETON, N.J., Dec. 2, 2024 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, along with ulrich GmbH & Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants, announced today the clearance of the Bracco branded Max 3™, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures.
Movano Health Receives FDA Clearance for EvieMED Ring
PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ — Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring.