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.
Nonin Medical secures FDA clearance for over-the-counter fingertip pulse oximeter, accurate for all skin colours
Disparities in the accuracy of blood oxygen readings are known to disproportionately affect patients of color, leading to significant health risks because of delayed care.
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.