Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.

GE HealthCare’s MIM Software today announced it received FDA 510(k) clearance for Monte Carlo dosimetry.

IRVINE, Calif., Oct. 3, 2024 /PRNewswire/ — OrthAlign, Inc., a privately held medical device company, announces FDA 510(k) clearance of their Lantern Hip handheld technology for direct anterior total hip arthroplasty with the patient in the supine position. Lantern Hip is the latest addition to the Lantern platform, joining existing applications for total knee, revision knee, and partial knee arthroplasty.

A 2025 commercial launch is planned to expand access to this platform technology.

The company says this is the first and only software validated on ground-truth histology, the gold standard for plaque characterisation according to the company.

The tiny device uses a tightly focused beam of light to capture and manipulate cells.

Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform.