Atraverse wins FDA nod for left-heart access device
May 15, 2024
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device.
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device.
Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.
The FDA has warned that home test users, caregivers and healthcare providers should not use Cue Health COVID-19 diagnostics.
LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ — Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor’s height, weight and hematocrit level on the day they donate plasma.
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.
4C Medical Technologies announced today that the FDA granted breakthrough device designation for its AltaValve system.
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
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..
Scientia Vascular,is thrilled to announce the FDA clearance of two uniquely engineered catheters: the Plato 17 and the Socrates 38.