Philips wins FDA clearance for AI-powered ultrasound workflow tech
June 2, 2026
Philips (NYSE:PHG) announced today that it received FDA clearance for its Elevate Plus advanced imaging and AI and automation capabilities.
Philips (NYSE:PHG) announced today that it received FDA clearance for its Elevate Plus advanced imaging and AI and automation capabilities.
Pulmera announced today that it received FDA 510(k) clearance for its CBeam 3D intraoperative imaging platform.
Edwards Lifesciences (NYSE:EW) said today that it received FDA approval for Triformis Resilia, its surgical tricuspid valve replacement.
The development coincides with several steps by SHINE Technologies to broaden its position in nuclear medicine.
SEOUL, South Korea, May 29, 2026 /PRNewswire/ — South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD.
Coredio’s AI software is used to monitor HF parameters via wearables and standard blood pressure cuffs.
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for its Afrezza inhaled insulin powder for children.
Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for a second Aquablation evaluation.
SINGAPORE, May 27, 2026 /PRNewswire/ — Gene Solutions, a global biotechnology company advancing accessible genomic solutions for cancer detection and precision oncology, today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SPOT-MAS 10, its multi-omic blood test designed to detect cancer-associated signals.