Regulatory

Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications

Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS […]

Idorsia submits a New Drug Application to the US FDA for aprocitentan for the treatment of patients with difficult-to-control hypertension

The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated Allschwil, Switzerland – December 20, 2022 Idorsia Ltd (SIX: IDIA) today announced that it […]

Valo Health – FDA Collaborative Study in Human Cardiac Tissues Demonstrates Potential to Predict Clinical Efficacy of Cardiac Contractility Modulation Devices to Treat Heart Failure

Findings Part of Five-Year Research Collaboration Between Valo and FDA Developed on Valo’s Biowire Platform BOSTON, Dec. 14, 2022 /PRNewswire/ — Valo Health, Inc (“Valo”) shared the initial results of a collaborative study with the U.S. Food and Drug Administration (FDA), demonstrating the potential […]

Alnylam Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration (FDA) for ONPATTRO® (patisiran)

– sNDA Submission is Based on Findings from the APOLLO-B Phase 3 Study That Showed Patisiran Demonstrated Significant Improvement on Functional Capacity, Health Status and Quality of Life Compared to Placebo at Month 12 – – Study Also Demonstrated Encouraging […]

Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction

EchoGo® Heart Failure revolutionizes the detection of HFpEF – the biggest unmet need in cardiovascular medicine.1 OXFORD, England, Dec. 6, 2022 /PRNewswire/ — Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with […]