MedTech News
Si-Bone touts first human case with pelvic fracture fixation device
Si-Bone today announced the first patient procedures with its FDA breakthrough device, the iFuse Torq TNT implant system.
Nature and plastics inspire breakthrough in soft sustainable materials
Biodegradable structures could revolutionize energy, information technologies and advanced medicine
AccurKardia wins FDA breakthrough nod for ECG-based AI screening software
AccurKardia announced that it received FDA breakthrough device designation for its aortic valve stenosis (AVS) ECG-based AI screening software.
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.