Other News

FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm

Developed in collaboration with Janssen and Mayo Clinic, this technology has the potential to aid physicians in earlier detection of pulmonary hypertension, a progressive, life-threatening disease CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the […]

inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION

System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions CAMBRIDGE, Mass. and BORDEAUX, France, May 24, 2022 /PRNewswire/ — inHEART, a privately-held medical device company delivering the world’s most sophisticated digital twin of the […]

Caladrius Biosciences Provides Update on Phase 2b FREEDOM Trial of XOWNA® in Coronary Microvascular Dysfunction

Interim analysis to be conducted following enrollment suspension in the double-blind, randomized, placebo-controlled clinical trial Next development steps for XOWNA® to be announced by year-end 2022 following regulatory and business review Caladrius Management will host a conference call tomorrow, May 24th at […]

First Patients Enrolled in IMPACT II Study to Evaluate Attune Medical’s ensoETM for Radiofrequency Ablation Procedures

Continued Research into Efficacy of ensoETM for RF Ablation Procedures Will Support Future Regulatory Efforts for Expanded Indications CHICAGO–(BUSINESS WIRE)–Attune Medical, a pioneering medical device company with a technology platform based on temperature management using the esophagus, announced today that the […]

Alnylam Presents New Results from the ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

– Lumasiran Demonstrated Evidence of Improvements in Exploratory Endpoints of Systemic Oxalosis, Including Echocardiographic Structure and Function, Nephrocalcinosis, and Kidney Stone Events – – Expands Upon Previously Reported Reductions in Plasma Oxalate in PH1 Patients with Severe Renal Impairment – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: […]

ZZ Biotech’s Stroke Drug Moves Closer to Pivotal Phase 3 Clinical Trial as the NIH Awards First Tranche of $30 Million Grant to the Keck School of Medicine of USC

3K3A-APC Granted Fast-Track Designation by FDA with Multinational Clinical Trial to Run Through NIH StrokeNet HOUSTON–(BUSINESS WIRE)–In a significant development for the treatment of acute ischemic stroke, the National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. […]