SAN DIEGO, Sept. 17, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has named AnaBios the recipient of a grant to further develop its unique drug discovery platform utilizing muscle cells from the human heart (cardiomyocytes). Funds from the grant will be used to develop a preclinical biomarker to identify the […]
Rhythm
CorWave Presented First Successful In Vivo 60-Day Study on Its Innovative LVAD Cardiac Support Device
CLICHY, France–(BUSINESS WIRE)–CorWave announced that it successfully completed its first 60-day preclinical study to evaluate its Left Ventricular Assist Device (LVAD). The results were presented at the 46th Annual Conference of the European Society for Artificial Organs (ESAO) in Hannover. Trevor Snyder, PhD, Senior Director, Translational and Clinical Research at CorWave, […]
Quantum Genomics Launches Study of Firibastat in Patients with Renal Failure
PARIS and NEW YORK, Sept. 11, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in developing a new drug class that a directly targets the brain to treat resistant hypertension and heart failure, today announced that it is launching an additional study with […]
Ablacon Announces Release of New and Improved Ablamap Technology Under Existing CE Mark
MENLO PARK, Calif., Sept. 10, 2019 /PRNewswire/ — Ablacon, Inc. (www.ablacon.com), an Ajax Health-funded company, announced today the release of an updated version of its Ablamap technology under the company’s existing CE Mark. The new update includes an enhanced physician experience and user interface, along with significantly faster processing times leading to improved […]
Abbott Announces New Data That Shows Artificial Intelligence Technology Can Help Doctors Better Determine Which Patients are Having a Heart Attack
New research found Abbott’s algorithm created through machine learning could give doctors a more individualized calculation, leveraging factors such as age, sex and the changing dynamics of troponin protein levels in the blood, to improve heart attack diagnosis This technology is the first machine learning developed algorithm that combines high […]
FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System
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 […]
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System in the Treatment of Pulmonary Arterial Hypertension (PAH)
– 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 […]
Netech Obtains FDA 510(k) Clearance for Delta 3300 – Defibrillator/Pacemaker Analyzer
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, […]
Bardy Diagnostics™ Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch
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 […]
iRhythm Announces Collaboration with Verily to Develop Health Management Solutions for Atrial Fibrillation Patients
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 […]



