MedTech News
.................... by Andrew Celentano
PreludeDx Receives FDA Breakthrough Device Designation for AidaBREAST® – Early-Stage Invasive Breast Cancer Assay
LAGUNA HILLS, Calif., April 29, 2026 /PRNewswire/ — Prelude Corporation (PreludeDx™), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the AidaBREAST® test.
Chest Wall Innovations Receives FDA 510(k) Clearance for PC Fix Rib Fixation System
HERSHEY, Pa., April 29, 2026 /PRNewswire/ — Chest Wall Innovations, a medical device company focused on advancing the standard of care in chest wall surgery, today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its PC Fix Rib Fixation System on April 24, 2026, clearing the path for U.S. commercialization.
Harnessing the Power of AI to Fight Lyme Disease
An anonymous gift helped Tufts researchers speed up a project to develop new drugs that could prevent and treat Lyme disease
First-Ever Smell Map Is a Breakthrough in Sensory Research, a Step to Help Us Tackle Loss of Smell
Discover how smell receptors in our noses aren’t randomly arranged but are highly organized, offering new paths toward treating sensory impairment.
Medtronic wins CE mark for Stealth AXiS surgical robot platform
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Stealth AXiS surgical robot platform.
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.