Regulatory

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 […]

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 […]

Teleflex Receives FDA Clearance for Wattson™ Temporary Pacing Guidewire

WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the WattsonTM Temporary Pacing Guidewire – the first commercially available bipolar temporary […]

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 […]

European Commission Grants BioVentrix CE Mark Extension for Revivent TC Less Invasive Ventricular Enhancement Therapy

SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced the extension of its CE Mark for the Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure to May 2024. “The extension of our CE Mark is not only an important […]

Ra Medical Systems Receives FDA IDE Approval to Begin Pivotal Atherectomy Clinical Study

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces approval from the U.S. Food and Drug Administration (FDA) that the Company has provided sufficient data to support initiating an investigational device exemption (IDE) to […]

FDA Grants Fast Track Designation to Arena Pharmaceuticals’ APD418 for Development in Decompensated Heart Failure Patients

– APD418 currently in Phase 1 clinical investigation – data expected this year SAN DIEGO, Jan. 16, 2020 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of […]

Biocardia Announces FDA Clearance for Morph DNA Deflectable Guide Catheter

SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System […]

Abbott to Initiate Trial to Study MitraClip as an Option for Moderate Surgical Risk Patients

– New clinical trial will assess first-of-its-kind MitraClip™ transcatheter mitral valve repair against current standard of care surgery in a new, expanded patient population – If successful, the REPAIR MR study has potential to expand MitraClip’s current indication (patients at prohibitive risk for surgery) to also include patients at moderate […]