Vision-MR Ablation Catheter Receives CE Mark

MINNEAPOLIS–(BUSINESS WIRE)–Imricor Medical Systems, Inc. (ASX:IMR) today announces that it has received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market in Europe. Imricor is the first and only company […]

Verily receives FDA 510(k) clearance for Study Watch with Irregular Pulse Monitor

One year ago, we received our first 510(k) clearance for ECG for Verily Study Watch — a wrist-worn, sensor-based device for non-invasive, continuous monitoring. Today, we’re thrilled to share that we’ve received a new 510(k) clearance for Study Watch with Irregular Pulse Monitor. This validates our approach at Verily to building robust, clinical […]

Bardy Diagnostics™ Announces Commercial Launch of the 14-Day Carnation Ambulatory Monitor (CAM) Patch

SEATTLE, Jan. 23, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by […]

Study Finds SureFlex® Steerable Guiding Sheath has Greater Contact Force Stability for Radiofrequency Ablations

TORONTO, Jan. 23, 2020 /PRNewswire/ – A study has found that use of Baylis Medical’s SureFlex Steerable Guiding Sheath results in greater contact force stability for radiofrequency ablations in pulmonary vein isolations. Stable contact force has been linked to more effective ablations, a therapy in which radiofrequency energy is used to create a […]

Medtronic Receives FDA Approval for Trial Evaluating New Energy Source with Pulsed Electric Fields to Treat Atrial Fibrillation

Investigative Technology Designed to Interrupt Irregular Pathways in the Heart DUBLIN, Jan. 23, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field […]

FDA Approves Medtronic Micra™ AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block

With FDA Approval, More Patients in the U.S. Are Now Candidates for a Leadless Pacing Option DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is […]

Biotricity Prepares its Filing for a 510(k) Application for its Advanced ECG Analysis Software

REDWOOD CITY, Calif., Jan. 22, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, announced today that it is finalizing its FDA filing for its next generation, advanced ECG analysis software with an expectation to file a 510(k) clearance application with the US FDA by end […]

BioSig Awarded Additional US Patent Claims for its PURE EP(TM) System

Westport, CT, Jan. 14, 2020 (GLOBE NEWSWIRE) — Company allowed a fifth utility patent Claims address methods for removing voltage offset from biomedical signals Eleven additional patent applications covering PURE EPTM System are currently pending BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary […]

Cardisio Demonstrates Unprecedented Accuracy in New Non-Invasive Coronary Artery Disease Detection

Peer-Reviewed Study Published in the ‘Journal of Electrocardiology’ Confirms Cardisio’s Non-Invasive, Low-Cost Test as a Highly Accurate CAD Detection Tool FRANKFURT, Germany, Jan. 13, 2020 /PRNewswire/ — The Journal of Electrocardiology has published a study showing unparalleled accuracy in non-invasive coronary artery disease (CAD) detection using Cardisio’s new low-cost method which involves no radiation exposure. […]

FDA Approves Less Invasive Surgical Approach for Abbott’s Heart Pump to Help Patients Avoid Open Heart Surgery

– For people battling advanced heart failure, Abbott’s HeartMate 3 heart pump can now be implanted through an incision in the chest wall versus open heart surgery – New, less invasive technique provides cardiac surgeons with the ability to choose the optimal surgical method for their patients ABBOTT PARK, Ill., Jan. […]