Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
Medtronic (NYSE: MDT)+
announced today that the FDA granted breakthrough device designation for its Infuse bone graft.
ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.
Orthofix (Nasdaq: OFIX)+
today announced it received FDA 510(k) clearance for its Rodeo Telescopic Nail.
OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation.
MISGAV, Israel, May 6, 2024 /PRNewswire/ — ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement in spinal fusion technology..
Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System.
Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.
The company’s 3rd FDA clearance accelerates the shift to AI-powered digital hematopathology, enhancing diagnostic speed and patient care