MedTech News
.................... by Andrew Celentano
FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions’ SPOT-MAS 10 Multi-Cancer Screening Test
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 Receives FDA De Novo Clearance for DeepView System for Burn Indication
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.
Subtle Medical Receives FDA Clearance for SubtleHD(PET) AI-Powered Image Enhancement Software
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.
Cardiosense Receives FDA De Novo Classification for AI-Powered Heart Failure Monitoring Software
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.
A New Genetic Map of the Human Eye Could One Day Reveal Vision Loss Years Before Symptoms Start
A new map of the human eye made using donated eyeballs that could help explain and possibly prevent a handful of sight-related diseases.
Human Cells Can Pass DNA to Each Other Through Tiny Tubes — Here’s How It May Fuel Cancer Growth
DNA can be exchanged between two cells that connect by forming nanotubes, and find out why this is crucial for cancer research.
ABILITY Neurotech receives MREC approval for ALS BCI clinical trial
The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.
Abbott wins CE mark for dual glucose-ketone sensor
Abbott (NYSE:ABT) announced today that it received CE mark approval for its dual glucose-ketone sensing technology for people with diabetes.