medical device guru

Cardiovascular / Cardiology
Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite
Materialise, a global 3D printing software and solutions company, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures. Mimics Enlight is based on...
June 21, 2019
Cardiovascular / Cardiology
Ra Medical Launches Study for Peripheral Laser Atherectomy Device
Ra Medical said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected...
June 19, 2019
Cardiovascular / Cardiology
CorMatrix Cor PATCH for Epicardial Tissue Repair Gets FDA Clearance
CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k) clearance for the Cor™ PATCH.  The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients. The Cor™ PATCH epicardial patch is...
June 14, 2019
Cardiovascular / Cardiology
Zoll Buys AED Developer Cardiac Science
Cardiac Science Corporation, a leading provider of automated external defibrillators (AEDs), related services and accessories, today announced it has entered into a definitive agreement to be acquired by ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices...
June 12, 2019
Cardiovascular / Cardiology
ClearFlow Announces Positive Trial Results for PleuraFlow Thoracic Evacuation Device
ClearFlow, Inc., a medical device company based in Anaheim, California, has announced that positive clinical trial results of its PleuraFlow® device were presented at the American Association for Thoracic Surgery (AATS) 99th Annual meeting on May 4 in Toronto, Canada....
May 22, 2019
Cardiovascular / Cardiology
FDA Approves First New Therapy to Treat Heart Attacks in Years
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage...
April 8, 2019
Cardiovascular / Cardiology
Genetesis CardioFlux Platform Receives FDA 510(k) Clearance
Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC). The technology is intended to be used by ER physicians and cardiologists to...
April 2, 2019
Cardiovascular / Cardiology
FDA Approves Breakthrough Optimizer Smart Device for Chronic Heart Failure
Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link to FDA announcement:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to...
March 21, 2019
Cardiovascular / Cardiology
Sonavex Receives FDA Clearance for Blood Flow Monitoring Technology
Following peripheral vascular and microvascular surgeries, it is important to be able to monitor how blood is flowing through the treated vessels and whether there may be an occlusion or compromise. This monitoring typically requires a nurse or a trained...
March 18, 2019
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