MedTech News
FDA clears Regenity Biosciences’ regenerative meniscus implant
Regenity Biosciences announced that it received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus.
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent.
Procept Biorobotics wins FDA nod to study surgical robot for treating prostate cancer
Procept BioRobotics (Nasdaq:PRCT) announced today that the FDA approved an investigational device exemption (IDE) trial for its Aquablation therapy.
FDA grants Breakthrough Device designation to Amphix Bio’s bone regeneration product
CHICAGO, Oct. 3, 2024 /PRNewswire/ — Amphix Bio, a company developing a new class of regenerative medicine therapies, announced today it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration. The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.
Corin wins FDA nod for Unity Knee tibial insert for robot-assisted TKA
Corin announced that it received FDA 510(k) clearance for its Unity Knee medial constrained (MC) tibial insert.
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.