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.
Spectral AI announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its DeepView System, authorizing the company to commence commercial distribution activities in the United States.
California-based Subtle Medical has announced FDA clearance for SubtleHD(PET), its next-generation PET image enhancement solution designed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems.
Chicago, Illinois-based Cardiosense announced that the US Food and Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software, which is designed to estimate noninvasively pulmonary capillary wedge pressure (PCWP), a key indicator of heart health.
The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.
Abbott (NYSE:ABT) announced today that it received CE mark approval for its dual glucose-ketone sensing technology for people with diabetes.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Alzheimer’s Test, a urine-based diagnostic test developed by TOBY, a biotechnology company based in Austin, Texas.
The CE certification confirms compliance with regulatory standards for safety, efficacy, and quality management.
Neurovalens announced today that it received FDA de novo approval for Modius Spero, a post-traumatic stress disorder (PTSD) therapy.