The Latest Cardiac and Vascular News
SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted BreakthrouThe FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or […]
– Designation facilitates more rapid approval and reimbursement for a breakthrough technology that offers significant advantages over current PAH treatment options – TEL AVIV, ISRAEL (PRWEB) SEPTEMBER 06, 2019 SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device […]
FARMINGDALE, N.Y., Sept. 9, 2019 /PRNewswire/ — Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer—the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing and validating the functions of all semi and automated defibrillators. This revolutionary compact, […]
SEATTLE, Sept. 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia […]
SAN FRANCISCO, Sept. 04, 2019 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC) today announced a collaboration with Verily, an Alphabet company, focused on the development of solutions aimed at improving the screening, diagnosis and management of patients with atrial fibrillation (AFib). This collaboration brings together iRhythm’s expertise in AI based arrhythmia […]
Late-breaking BackBeat CNT™ randomized, double-blind clinical results selected by Cardiovascular Research Foundation for presentation at TCT 2019 NEW HOPE, Pa., Sept. 04, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today […]
– ENTRUST-AF PCI study achieved the primary safety endpoint of non-inferiority in bleeding for edoxaban-based dual therapy compared with VKA-based triple antithrombotic therapy (using a risk-based duration of ASA for at least one month) in AF patients following stent placement – Data contributes to growing body of evidence supporting edoxaban in combination […]
PARIS–(BUSINESS WIRE)–Results from The Atrial Fibrillation Progression Trial (ATTEST), were presented on August 31st at the ESC* Congress 2019 in Paris, France. ATTEST is the first randomised controlled trial to directly compare the effectiveness of ablation using radiofrequency (RF) catheters versus standard antiarrhythmic drugs (AAD) in delaying atrial fibrillation (AF) progression. The […]
The new Impella CP heart pump features a fiber optic sensor, optimally positioned to measure the placement signal in the aorta, identify pump placement and enable repositioning without the use of imaging. (Graphic: Abiomed) PARIS–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces today that the Impella CP® with SmartAssist technology, which is designed to improve patient […]
10 years ago, RE-LY® marked the first time a randomised trial showed that a non-vitamin K antagonist oral anticoagulant (NOAC) was safer and at least as effective as warfarin for stroke prevention in atrial fibrillation (SPAF)1-3 First major scientific advancement in anticoagulation care in over fifty years Over 100,000 patients have […]
