medical device guru

Cardiovascular / Cardiology
Avinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System
Avinger, Inc., a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food &...
September 11, 2020
Cardiovascular / Cardiology
Medtronic Tricuspid Valve Replacement Device Wins FDA Breakthrough Status
Medtronic, a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a...
September 9, 2020
Cardiovascular / Cardiology
CryoLife Acquires Ascyrus Medical
CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has acquired Ascyrus Medical LLC.  Ascyrus is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent, the world’s first aortic arch remodeling...
September 3, 2020
Cardiovascular / Cardiology
Philips to Acquire Intact Vascular for $275M
Royal Philips, a global leader in health technology, today announced that it has signed an agreement to acquire Intact Vascular, Inc., a U.S.-based developer of medical devices for minimally-invasive peripheral vascular procedures. Intact Vascular will enhance Philips’ image-guided therapy portfolio,...
August 28, 2020
Cardiovascular / Cardiology
RapidAI Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions
RapidAI, the worldwide leader in advanced imaging for stroke, today announced that Rapid LVO has received Food and Drug Administration (FDA) clearance for detecting suspected LVOs (Large Vessel Occlusions). Rapid LVO helps physicians speed up triage or transfer decision-making. Working...
August 13, 2020
Cardiovascular / Cardiology
Eko and AstraZeneca Announce Digital Cardiovascular Health Partnership
Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart failure. “There are millions of people living with or at risk for heart failure. AstraZeneca’s...
August 5, 2020
Cardiovascular / Cardiology
Rapid Medical Receives CE Mark for Stentriever
Rapid Medical, a company focused on the development of next generation neurovascular devices, has announced that it received CE Mark for TIGERTRIEVER XL. In addition, the first patients have been treated successfully with the device. The TIGERTRIEVER family of stentrievers...
July 27, 2020
Cardiovascular / Cardiology
Artio Medical Acquires Flow Forward Medical, Expanding Peripheral Vascular Portfolio
Artio Medical, Inc. (Artio) today announced it has acquired Flow Forward Medical, Inc. (Flow Forward), a medical device company developing innovative methods for establishing and maintaining high-quality vascular access sites to improve outcomes for hemodialysis patients. This stock-for-stock merger transaction...
July 24, 2020
Cardiovascular / Cardiology
FDA Clears Nonin Medical’s Flagship Product
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as...
July 9, 2020
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