FDA

Further enhancing comprehensive trauma care solution

RapidAI Receives FDA Clearance of AI Module for Detection of Hemispheric Subdural Hematomas

November 9, 2023 — RapidAI, a global leader in developing artificial intelligence (AI) and technology workflow solutions ...

November 09, 2023

Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

News | FDA

First FDA Approval of Renal Denervation System to Treat Hypertension Announced by Recor Medical and Otsuka Medical Devices

November 8, 2023 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U ...

November 08, 2023

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

News | FDA

Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling

November 7, 2023 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow ...

November 07, 2023

News | VIVA

VIVA23 Presents Outcomes of Late-breaking Science from Abbott’s LIFE-BTK, RESOLV FIH Study, and IN.PACT AV Access Trial

November 2, 2023 — The second round of late-breaking clinical trials results from the Vascular InterVentional Advances ...

November 01, 2023

The findings will impact the interventional treatment of High Bleeding Risk patients

News | Ventricular Assist Devices (VAD)

Tenaya Therapeutics Announces FDA Clearance to Begin Clinical Testing of TN-401 Gene Therapy for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

October 31, 2023 — Tenaya Therapeutics, Inc., a clinical-stage biotechnology company with a mission to discover, develop ...

October 31, 2023

Abbott's landmark LIFE-BTK randomized clinical trial met its primary safety and effectiveness endpoints, demonstrating that Esprit BTK offers significant advancements in opening and keeping blocked arteries below-the-knee open compared to the standard of care, balloon angioplasty

News | Stents Bioresorbable

Late-breaking Data Show Esprit BTK Drug-eluting Resorbable Scaffold Reduces Chronic Limb-threatening Ischemia Progression Compared to the Standard of Care

October 30, 2023 — Abbott announced late-breaking data from the LIFE-BTK clinical trial evaluating the Esprit BTK ...

October 30, 2023

Dr. William Gray of Lankenau Institute for Medical Research, part of Main Line Health, guided research presented at cardiology conference and published by Lancet

News | Peripheral Artery Disease (PAD)

Study Organized by Main Line Health Researchers Reverses FDA Warning on Vital Peripheral Artery Disease Treatment

October 24, 2023 — Four years ago, following a publication based on the limited data available, the U.S. Food and Drug ...

October 24, 2023

News | Implantable Cardioverter Defibrillator (ICD)

Medtronic Receives FDA Approval for Extravascular Defibrillator to Treat Abnormal Heart Rhythms, Sudden Cardiac Arrest

October 23, 2023 — Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug ...

October 23, 2023

Cardiovascular Research Foundation's (CRF) annual scientific symposium, Transcatheter Cardiovascular Therapeutics, TCT 2023, is set for October 23-26 in San Francisco

Feature | TCT | Christine Book

TCT 2023 Leadership Anticipates 'Practice Changing' Findings Ahead of 35th Scientific Symposium

October 18, 2023 — The following is an updated program preview of the Cardiovascular Research Foundation's (CRF) annual ...

October 18, 2023

InfoBionic announces FDA 510(k) clearance for its MoMe ARC solution that encompasses our next generation remote ECG monitoring device and initial Bluetooth diagnostic 6-lead sensor designed to aid physicians in their diagnosis of cardiac arrhythmias

News | ECG

InfoBionic Receives FDA 510(k) Clearance for its Next Generation MoMe ARC Solution

October 13, 2023 — InfoBionic, Inc. today announced that it received 510(k) clearance from the U.S. Food and Drug ...

October 13, 2023

$Based on pioneering research from Mayo Clinic, ECG-AI LEF aims to aid physicians in identifying low ejection fraction in patients at risk of heart failure$

News | FDA

Anumana Receives U.S. FDA 510(k) Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction

October 4, 2023 — Anumana, Inc., a leading AI-driven health technology and nference portfolio company working in ...

October 04, 2023

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

News | FDA

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