MedTech News
Medivis Receives FDA 510(k) Clearance for Spine Navigation and Announces Commercial Launch in the United States
NEW YORK, April 2, 2025 /PRNewswire/ — Medivis Inc., a pioneer in surgical intelligence, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Spine Navigation platform. This milestone marks a significant advancement in surgical technology, utilizing AR and AI to empower surgeons with holographic navigation across open and minimally invasive spine procedures. Alongside the FDA clearance, Medivis is announcing the commercial launch of Spine Navigation, making it available to hospitals and ambulatory surgical centers nationwide.
Mass layoffs start at HHS: ‘FDA as we’ve known it is finished’
The Trump Administration has started mass layoffs at the FDA, CDC, NIH and other agencies within the Department of Health and Human Services, following up on a plan announced last week for Elon Musk’s DOGE team to shrink the workforce by 20,000 people through voluntary separations and new terminations.
Teleflex wins FDA nod for intra-aortic balloon pump
Teleflex (NYSE: TFX)+
announced today that it received FDA 510(k) clearance for its AC Range intra-aortic balloon pump (IABP).
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.
Zimmer Biomet Receives CE Mark Approval for RibFix Advantage® Fixation System
WARSAW, Ind., and ZUG, Switzerland, April 1, 2025 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE: ZBH and SIX: ZBH), a global medical technology leader, today announced its RibFix Advantage® Fixation System has received CE Mark certification – the first CE Mark for an intrathoracic rib fixation system.
FDA clears Boston Scientific Bolt IVL system
Boston Scientific (NYSE: BSX) has received FDA clearance for its Bolt intravascular lithotripsy (IVL) system, according to the FDA’s 510(k) database.
New Ultrasound Imaging Technique Helps Doctors See Inflammatory Bowel Disease Activity at the Bedside with no Sedation or Radiation
WASHINGTON, March 31, 2025 /PRNewswire/ — MedStar Georgetown University Hospital is the first hospital in the Washington, D.C. region to offer bedside intestinal ultrasound (IUS) to monitor inflammation in IBD patients. To assess chronic inflammatory diseases of the intestines, like Crohn’s disease and ulcerative colitis, patients are traditionally monitored with blood tests, stool studies, MRI or CT scans, and colonoscopies. Those kinds of tests can require bowel preparation, sedation, anesthesia, and radiation.
AZmed Receives Two New FDA Clearances for Its AI-Powered Chest X-ray Solution
PARIS, March 31, 2025 /PRNewswire/ — AZmed, one of the leading AI companies in medical imaging, today announced that it has received two new U.S. Food and Drug Administration (FDA) clearances for its AI tool AZchest. The clearances include applications intended to assist radiologists in the interpretation and detection of chest X-rays for lung nodules and triage capabilities for pneumothorax and pleural effusion.