Rhythm

Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy™ Drives Significant Reduction in Systolic Blood Pressure

Double-blind, randomized trial data demonstrates clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure at 6 months vs. control High responder rate despite 88.5% of treated patients having isolated systolic hypertension (ISH) Primary safety endpoint achieved with no difference in major cardiac […]

Fitbit and FibriCheck Announce Partnership to Deliver CE-Marked Heart Health Detection App to Fitbit Smartwatch Users in Europe

Fitbit users in Belgium, the Netherlands, Ireland and the United Kingdom can use FibriCheck to help detect heart rhythm irregularities like Atrial Fibrillation SAN FRANCISCO–(BUSINESS WIRE)–Fitbit (NYSE:FIT) and FibriCheck, an innovative health screening and monitoring app, today announced a partnership enabling users in Belgium, the Netherlands, Ireland and the UK to […]

FDA Awards AnaBios Grant to Further Develop Preclinical Assay Using Human Primary Cardiomyocytes

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 […]

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, […]

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, […]