FDA

EnCompass plans to immediately initiate clinical site start-up activities in the US

EnCompass receives FDA conditional IDE approval to commence a US pilot study of its F2 cerebral embolic protection (CEP) system in patients undergoing transcatheter aortic valve replacement (TAVR)

October 3, 2023 — EnCompass Technologies, Inc., a privately held medical device company focused on protecting patients ...

October 03, 2023

Application based on clinically meaningful results from the Phase 3 STELLAR trial

News | Cardiovascular Clinical Studies

Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)

September 28, 2023 — Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a ...

September 28, 2023

Boston Scientific announced the FDA clearance of the AVVIGOTM+ Multi-Modality Guidance System

News | FDA

Boston Scientific Announces FDA Clearance of the AVVIGO + Multi-Modality Guidance System

September 27, 2023 — Boston Scientific announced the FDA clearance of the AVVIGOTM+ Multi-Modality Guidance System, a ...

September 27, 2023

IDE supported by data from the MODERATO II randomized pilot study that showed AVIM therapy drove significant and sustained reductions in blood pressure in hypertensive pacemaker patients

News | Hypertension

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT for the Treatment of Hypertension in Pacemaker Patients

September 20, 2023 — Orchestra BioMed Holdings, Inc., a biomedical company accelerating high-impact technologies to ...

September 20, 2023

SmartCardia has received FDA clearance for its 7-lead real-time ECG monitoring patch and cloud platform

News | Wearables

SmartCardia Receives FDA Clearance for its 14-Day 7-Lead ECG Real-Time Patch and Cloud Platform

September 19, 2023 — SmartCardia has received FDA clearance for its 7-lead real-time ECG monitoring patch and cloud ...

September 19, 2023

New therapeutic option has potential to reduce rate of major limb amputation in US

News | Peripheral Artery Disease (PAD)

FDA Approves LimFlow System in Patients with Chronic Limb-threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

September 14, 2023 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chro ...

September 14, 2023

New stroke risk reduction therapy with thromboresistant coating is designed to advance procedural performance and safety

News | Left Atrial Appendage (LAA) Occluders

Boston Scientific Announces FDA Approval for the Latest-Generation WATCHMAN FLX Pro Left Atrial Appendage Closure Device

September 7, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration approval ...

September 07, 2023

Updated AI-based software is designed to improve cardiac ablation outcomes and procedural efficiencies

News | ECG

Vektor Medical Unveils Enhanced vMap Technology for Accurate, Non-invasive Mapping of Cardiac Arrhythmias

September 6, 2023 — Vektor Medical, developer of the only technology to accurately map arrhythmias using just 12-lead EC ...

September 06, 2023

Magenta Medical, developer of the Elevate heart pump system, an FDA Designated Breakthrough Device, recently announced the completion of its FDA-approved Early Feasibility Study for the high-risk percutaneous coronary intervention (HR-PCI) indication.

News | Cardiovascular Clinical Studies

Magenta Medical Completes Enrollment to Early Feasibility Study for World’s Smallest Heart Pump

September 6, 2023 — Magenta Medical, developer of the Elevate heart pump system, an FDA Designated Breakthrough Device ...

September 06, 2023

Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter

News | FDA

Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

August 18, 2023 — The U.S. Food and Drug Administration (FDA) announced that Abiomed is recalling the labeling for ...

August 18, 2023

News | FDA

Argus Cognitive Receives FDA Clearance for 3D Echocardiographic Right Ventricular Analysis Tool

August 15, 2023 — Argus Cognitive, Inc., a digital health company that develops software medical devices, announced ...

August 15, 2023

The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board and/or Solenoid Board (Power Source Path).

News | Intra-Aortic Balloon Pumps (IABP)

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

August 14, 2023 — The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue ...

August 14, 2023

Partnership makes AI4MedImaging’s AI4CMR solution available on the Blackford Platform

News | Artificial Intelligence

Blackford and AI4MedImaging Announce Partnership to enhance AI solutions offering for Cardiac MRI

August 10, 2023 — Blackford, the pioneering strategic imaging AI platform and solutions provider, and AI4MedImaging, a ...

August 10, 2023

News | Artificial Intelligence

AI Breakthrough Award Presented to Cleerly CCTA Digital Care Platform

August 10, 2023 — Cleerly, an artificial intelligence (AI) digital healthcare company, recently announced it was named ...

August 10, 2023

Game-changing potential for drug testing and cardiovascular disease treatments - Tiny Heart Model carries massive implications

News | Cardiovascular Clinical Studies

Tiny, Multichambered Human Heart Model Developed by Hebrew University Researchers Could Transform Cardiovascular Research and Drug Evaluation

August 9, 2023 — A team of researchers, led by the Hebrew University of Jerusalem (HU), has developed a tiny human heart ...

August 09, 2023