The Latest Cardiac and Vascular News
WATCHMAN FLX now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation MARLBOROUGH, Mass., Sept. 6, 2022 /PRNewswire/ — Boston Scientific Corporation ( NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the current-generation WATCHMAN FLX™ Left […]
SHENZHEN, China, Sept. 5, 2022 /PRNewswire/ — LifeTech Scientific Corporation (Stock Code: 1302.HK) is pleased to announce that on 30 August 2022, an FDA-approved investigator-initiated pre-market clinical trial of its proprietary LAmbre™ Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in the United States, meaning that all patient enrollment of […]
SOUTH SAN FRANCISCO, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced clearance of its Investigational New Drug (IND) application to begin clinical testing of […]
Part of the Viz PE Solution, new algorithm flags key patient risk indicator of pulmonary embolism severity SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an automated RV/LV ratio algorithm, a seamless […]
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to […]
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation […]
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis RAHWAY, N.J.–(BUSINESS WIRE)– Merck, (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck’s investigational anticoagulant therapy […]
Submission Seeks Approval for the Company’s Proprietary ECG Technology to Aid in Diagnosis of Heart Attack in $500 million Total Addressable Market 18+ million People in the US have Coronary Artery Disease and Heart Attacks Occur Every 40 Seconds SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital […]
Medicalgorithmics has received FDA approval in the U.S. for its proprietary next generation system in ECG signal analysis called DeepRhytmAI. WARSAW, Poland, Aug. 10, 2022 /PRNewswire/ — It is a cloud-based Artificial Intelligence algorithm that classifies ECG signals. Without excessive human involvement, DeepRhytmAI is able to recognize a wide range of arrhythmia disorders […]
GENEVA, Aug. 9, 2022 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION […]
