Regulatory Approvals

The device includes an eInk screen that allows physicians and patients to interact with the wearable. The US Food and Drug Administration (FDA) has approved Medicalgorithmics’ ECG...

LOBO-7 and LOBO-9 are intended for use in 5mm to 7mm and 7mm to 9mm diameter vessels, respectively. Okami Medical has received 510k clearance from the US...

Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes,...

Abbott  announced that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor. FDA clearance for the latest iteration of the company’s...

Medtronic  announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon...

OmniGuide Holdings (OGH) , the U.S. Food and Drug Administration cleared RevoLix™ HTL a family of pulsed and continuous wave Thulium YAG lasers is the foundation...

Manamed, a pioneering Medical Technology development company, has been granted FDA approval on its latest orthopedic recovery device, ManaSport. LAS VEGAS, May 26, 2022 /PRNewswire/ -- ManaMed...

System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions  inHEART, a privately-held medical device...

The Rapid PE Triage & Notification tool analyzes CT pulmonary angiograms to find potential cases and alert care teams. RapidAI, a health tech company that...