Olympus wins FDA clearance for Powerseal open extended jaw device
April 28, 2026
Olympus announced today that it received FDA 510(k) clearance for its Powerseal open extended jaw sealer/divider for use in open surgery
Olympus announced today that it received FDA 510(k) clearance for its Powerseal open extended jaw sealer/divider for use in open surgery
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.
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.
Researchers at NYU Abu Dhabi have developed soft, flexible sensors that help restore a surgeon’s sense of touch during minimally invasive (keyhole) surgery.
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.
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.
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.
BURLINGTON, Mass., April 28, 2026 /PRNewswire/ — SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European Medicines Agency (EMA) for review under the centralized procedure on the basis of technical innovation. Together, these milestones represent a significant step forward in bringing this novel at-home subcutaneous furosemide treatment to patients in Europe and other international markets.
Motif Neurotech announced today that it received FDA investigational device exemption (IDE) to evaluate its brain stimulation implant.
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy.