DUBLIN – May 1, 2019 – Medtronic plc (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left […]
Rhythm
VivaQuant Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device
ST. PAUL, Minn.–(BUSINESS WIRE)–VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device. RX-1 continuously monitors a patient’s ECG as they go about their normal daily activities, identifies arrhythmias, and communicates the information to […]
Murj 2.0 Gives Cardiologists a 360-Degree Implantable Device Patient View
SANTA CRUZ, Calif., April 30, 2019 (GLOBE NEWSWIRE) — Murj, the digital healthcare company providing Software-as-a-Service (SaaS) cardiac implantable electronic device (CIED) management, announced today the immediate availability of Murj 2.0. This revolutionary implantable cardiac device management software empowers clinicians to deliver superior patient care in ways never before possible. […]
Precision Optics Corporation, Inc. Announces Receipt of $2.2 Million Order For Custom Designed Cardiovascular Endoscope
GARDNER, Mass., April 29, 2019 (GLOBE NEWSWIRE) — Precision Optics Corporation, Inc. (OTCQB: PEYE) today announced that it has received a follow-on order totaling $2,216,000 from CardioFocus, Inc. for the manufacture of a cardiovascular endoscope to support the HeartLight Endoscopic Ablation System. Deliveries are scheduled to be made over two […]
Ablacon, Inc. Raises $21.5M Series A to Advance AI-Enabled Atrial Fibrillation Mapping System
MENLO PARK, Calif., April 30, 2019 /PRNewswire/ — Ablacon, Inc. (www.ablacon.com), a Wheat Ridge, CO-based company developing an advanced mapping system to guide the treatment of atrial fibrillation (AFib), today announced the closing of a $21.5 million Series A financing round led by Ajax Health. Ablacon’s novel algorithm uses artificial intelligence (AI) to analyze and visualize […]
Acutus Medical’s New Contact Mapping Software Receives CE Mark
CARLSBAD, Calif. and MANNHEIM, Germany, April 26, 2019 /PRNewswire/ — Acutus Medical today announced CE mark approval for AcQMap contact mapping software, offering expanded functionality that provides physicians with more options to inform individualized patient therapy. The company also announced FDA clearance of its second generation AcQMap platform. All AcQMap systems retain the unique ability to […]
Alchem International Solves Stability Problems in Micronized Digoxin and Files Patent for New Manufacturing Process
GENEVA, April 25, 2019 / PRNewswire / – Alchem International Private Limited (“Alchem”), a privately held pharmaceutical company specializing in the production of plant-derived active pharmaceutical ingredients (APIs), today announced the launch of its platform owner of micronized digoxin. The Alchem molecule is the only micronized digoxin available worldwide that […]
Endotronix Receives ISO 13485:2016 Certification
LISLE, Ill., April 24, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix’s adherence to internationally recognized standards for the […]
AtriCure Announces First Patient Enrollment in the DEEP IDE Trial Restart
MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatment for atrial fibrillation (Afib) and left atrial appendage management, today announced the restart of the Dual Epicardial and Endocardial Procedure (DEEP) clinical trial (NCT02393885). Following approval by the FDA to restart the trial and enroll an additional 40 subjects, […]
FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
MOUNTAIN VIEW, Calif., April 23, 2019 /PRNewswire/ — AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias. In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus […]



