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 […]
Tag: FDA
CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System
US Based Pilot Study to enroll patients who develop communicating hydrocephalus following subarachnoid hemorrhage BOSTON, Aug. 9, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food […]
INSERTING and REPLACING Viz.ai Receives FDA 510(k) Clearance for Viz SDH
AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care SAN FRANCISCO–(BUSINESS WIRE)–Insert after fourth paragraph of release: footnote 2. The updated release reads: VIZ.AI RECEIVES FDA 510(K) CLEARANCE FOR VIZ SDH AI-powered Viz SDH automatically detects […]
Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device
TIGERTRIEVER™13 is designed to reduce vessel tension during ischemic stroke treatment YOKNEAM, Israel & TORONTO–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting […]
Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program Evaluating Sotagliflozin in Almost 12,000 People THE WOODLANDS, Texas, July 27, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted […]
RapidAI Receives FDA Clearance for Rapid Hyperdensity
The new solution allows for quick identification of hyperdense volumes to improve hemorrhage management SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, […]
Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System
Designation Allows for Expedited Review of Transcatheter Therapy Designed to Improve Left Ventricular Structure and Function in Heart Failure Patients with Reduced Ejection Fraction SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel device-based therapy to address heart […]
FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics
First and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope OAKLAND, Calif., July 12, 2022 /PRNewswire/ — Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food […]
Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer
Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a Phase 3 trial (The ASTER […]
Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter
Board of Directors continues its review of strategic alternatives to determine the Company’s optimal path forward CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system […]