MedTech News
FDA authorizes Pi-Cardia’s valve-in-valve TAVR device
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 wins FDA clearance for Monte Carlo dosimetry
GE HealthCare’s MIM Software today announced it received FDA 510(k) clearance for Monte Carlo dosimetry.
OrthAlign Receives FDA 510(k) Clearance for Lantern® Hip
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.
OrganOx metra system approved for liver transplantation in Canada
A 2025 commercial launch is planned to expand access to this platform technology.
Elucid receives FDA clearance for PlaqueIQ image analysis software
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.
MIT engineers create a chip-based tractor beam for biological particles
The tiny device uses a tightly focused beam of light to capture and manipulate cells.
Eyenovia begins manufacturing next-gen drug delivery system
Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform.
SetPoint Medical gets FDA IDE to study neurostimulation for MS
SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis.