Author: Ken Dropiewski

Intermountain Health Extends Leadership in Heart Care with Adoption of Advanced Robotic Technology

ST. LOUIS, Feb. 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced the first treatment of patients with a newly launched Genesis Robotic Magnetic Navigation (RMN) system at Intermountain Medical Center, flagship hospital of Intermountain Health, based in Salt […]

Cleerly® ISCHEMIA™ Software Device Billable With AMA Category I CPT® Code for Noninvasive Estimates of Fractional Flow Reserve

DENVER–(BUSINESS WIRE)–Cleerly, the company creating a new standard of care to aid in the diagnosis of heart disease, announced that its recently U.S. Food and Drug Administration (FDA)-cleared Cleerly ISCHEMIA software device applied to a non-invasive coronary CT angiogram (CCTA) can be billed using the new Category I CPT® code 75580. The American […]

BridgeBio Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

– Submitted New Drug Application (NDA) to US Food and Drug Administration (FDA) for acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) based on positive results of Phase 3 ATTRibute-CM trial, which were published in the New England Journal of Medicine; NDA has been accepted for review with a […]

Teleflex Reports Fourth Quarter and Full Year 2023 Financial Results

WAYNE, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX) (the “Company”) today announced financial results for the fourth quarter ended December 31, 2023. Fourth quarter financial summary Revenues of $773.9 million, reflective of five fewer shipping days year-over-year, up 2.1% compared to the prior year period; up 0.7% on […]

PrepMD Partners with MediaSphere and Esteemed Cardiac Experts for Groundbreaking Virtual Device Clinic Leadership Summit

BRAINTREE, Mass., Feb. 21, 2024 /PRNewswire/ — PrepMD, as the exclusive sponsor, is thrilled to announce its partnership with MediaSphere and distinguished cardiac professionals, including Beth Davenport and Sallie Gustafson, to present the largest-ever virtual accredited Cardiac Device…

Kiniksa Pharmaceuticals to Report Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024

HAMILTON, Bermuda, Feb. 21, 2024 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Wednesday, February 28, 2024 at 8:30 a.m. Eastern Time to report its fourth quarter and full-year 2023 financial results and recent portfolio execution. A […]

Saghmos Therapeutics Announces Appointment of FDA Veteran Stephen Grant, MD, as Chief Regulatory Officer

GREENWICH, Conn.–(BUSINESS WIRE)–Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer. Dr. Grant was the former Deputy Director, Division of Cardiology and Nephrology at the FDA. During his more than 20-year career at the FDA, he was responsible for […]

Route 92 Medical Announces Completion of Enrollment in the SUMMIT MAX Clinical Trial

SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial (NCT05018650) evaluating the safety and effectiveness of its HiPoint™ 88 […]

X-trodes Receives FDA 510(k) Clearance for Wearable “Skin” Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home

HERZLIYA, Israel, Feb. 20, 2024 /PRNewswire/ — X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for X-trodes’ Smart Skin solution (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring. X-trodes’ Smart Skin is comprised of customizable dry-printed […]

Endovascular Engineering Announces First Patient Enrolled in ENGULF Pivotal Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Feb. 20, 2024 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”), a pioneering medical device company at the forefront of advancing clot removal technologies for venous thromboembolism (VTE), proudly announces the enrollment and treatment of the first patient in the…