MedTech News
.................... by Andrew Celentano
Abbott earns FDA clearance, CE mark for next-gen coronary imaging platform
Abbott (NYSE:ABT) announced today that it received FDA clearance and CE mark for its next-generation Ultreon 3.0 software.
Olympus wins FDA clearance for Powerseal open extended jaw device
Olympus announced today that it received FDA 510(k) clearance for its Powerseal open extended jaw sealer/divider for use in open surgery
AI model detects normally ‘invisible’ tissue changes of pancreatic cancer at stage 0
An AI model (REDMOD) can pick up the very early subtle tissue changes of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, which conventional imaging and the human eye find difficult to detect, finds research published online in the journal Gut.
From gut to brain: Scientists engineer bacteria to treat severe liver-related brain dysfunction
A research team engineered strains of a naturally occurring beneficial gut bacterium to function as programmable therapeutics capable of restoring metabolic balance across the gut, liver and brain.
Smart soft sensors restore surgeons’ sense of touch in minimally invasive procedures
Researchers at NYU Abu Dhabi have developed soft, flexible sensors that help restore a surgeon’s sense of touch during minimally invasive (keyhole) surgery.
Lab-grown human skin advances our understanding of the critical role of skin blood vessels
New research has shown that single blood vessel cells that appear in the earliest stages of lab-grown skin organoids have the ability to form complex microvascular networks that grow and mature over time.
3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ — 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026.
U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder
IRVINE, Calif., April 28, 2026 /PRNewswire/ — Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of schizophrenia and bipolar I disorder in symptomatic patients.