Rhythm

Biofourmis Partners with ImagineMIC to Pioneer Collaborative Remote Patient Monitoring Model

Biofourmis’ artificial intelligence-powered RhythmAnalytics® to provide clinical decision support that IDs cardiac arrhythmias and other issues requiring intervention BOSTON, Jan. 30, 2020 /PRNewswire/ — Biofourmis, a fast-growing global leader in digital therapeutics that powers personally predictive care, and ImagineMIC™ announced a partnership agreement today to drive improved outcomes and lower healthcare costs for […]

Late-Breaking Clinical Study Presented at AF Symposium 2020 Evaluates Attune Medical’s ensoETM For Use During Cardiac Ablation Procedures

CHICAGO–(BUSINESS WIRE)–Chicago-based medical device firm Attune Medical announced the presentation of clinical results from the largest device study to date designed to evaluate the performance of its ensoETM patient temperature management device as an aid in the reduction of esophageal injury during cardiac ablation, a common treatment for atrial fibrillation. […]

FDA Clears Eko’s AFib and Heart Murmur Detection Algorithms, Making It the First AI-Powered Stethoscope to Screen for Serious Heart Conditions

Eko’s algorithms alert clinicians to the presence of heart murmurs and atrial fibrillation (AFib) during the physical exam, converting the classic stethoscope into a powerful early detection tool SAN FRANCISCO–(BUSINESS WIRE)–Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, announced today that the U.S. […]

Acceleron Announces Sotatercept Achieved Primary and Secondary Endpoints in the PULSAR Phase 2 Placebo-Controlled Trial in Patients with Pulmonary Arterial Hypertension

– The PULSAR trial achieved its primary endpoint: a statistically significant reduction in pulmonary vascular resistance – – The trial also achieved statistically significant improvements in the key secondary endpoint of six-minute walk distance (6MWD) and other secondary endpoints, including amino-terminal brain natriuretic propeptide (NT-proBNP), and World Health Organization (WHO) […]

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 […]