FDA

FDA Announces Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits
June 13, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and their subsidiary Arrow International, are recalling the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and ...
FDA Announces Abbott Recall of HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit
May 15, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling the HeartMate 3 LVAS by updating the instructions for use after complaint reviews identified blood leakage ...
FDA Notes Safety and Quality Concerns with Getinge/Maquet Cardiovascular Devices
May 8, 2024 — The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet ...
DAIC's Top 10 for April
Clinical trials and innovative technology took center stage during the month of April, racking up some record number views. Here is a look at what DAIC viewers were reading last month: 1. New Study ...

FibriCheck is now the only FDA-cleared smartphone application for heart rhythm monitoring with ECG equivalence in the U.S.

News | ECG Monitoring Services

FibriCheck Enters US Market with FDA Clearance

July 24, 2024 — After a rigorous investigation procedure by the Food and Drug Administration, FibriCheck is now FDA ...

July 24, 2024

Globally approved maximum diameter expansion aims to provide new options in larger diameter and tapered vessels

News | FDA

FDA Issues Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop

July 2, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott has issued a correction for its ...

July 02, 2024

News | Artificial Intelligence

AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

June 25, 2024 — AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food and Drug ...

June 25, 2024

Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year

News | Heart Failure

Endotronix Receives FDA Premarket Approval of the Cordella PA Sensor System for the Treatment of Heart Failure

June 24, 2024 — Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at ...

June 24, 2024

Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

News | FDA

Elixir Medical Granted FDA Breakthrough Device Designation for DynamX Bioadaptor

June 18, 2024 — Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary ...

June 18, 2024

EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market

News | FDA

Elutia Announces FDA Clearance of EluPro: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators

June 17, 2024 — Elutia Inc., a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting ...

June 17, 2024

Xeltis synthetic restorative pulmonary heart valve evolves into a fully functioning, natural heart valve through colonization by the patient’s own tissue.

News | FDA

Xeltis Receives IDE Approval from FDA for Initiation of US Pivotal Trial for aXess, its Restorative Vascular Access Conduit

June 13, 2024 — Xeltis, a leading developer of transformative implants that enable the natural creation of living and ...

June 13, 2024

News | Balloon Catheter

FDA Announces Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits

June 13, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and their subsidiary Arrow ...

June 13, 2024

News | Stents

Philips launches Duo Venous Stent System for Treatment of Symptomatic Venous Outflow Obstruction

June 12, 2024 — Royal Philips, a global leader in health technology, announced the first implant of the Duo Venous Stent ...

June 12, 2024

Heuron ICH has received FDA 510(k) clearance

News | FDA

Heuron Gets FDA Green Light for Stroke Triage and Notification Solution

June 3, 2024 — Heuron, a specialized medical AI startup focused on brain and neurological disorders based in South Korea ...

June 03, 2024

Artificial intelligence (AI)-driven health technology company, Anumana, which developed the FDA-approved ECG-AI LEF algorithm, has announced its receipt of the International Organization for Standardization (ISO) 13485 certification for its Quality Management System.

News | Artificial Intelligence

Cardiac Care AI Company, Anumana, Announces Receipt of ISO 13485 Certification

May 21, 2024 — Anumana, a Cambridge, MA-based artificial intelligence (AI)-driven health technology company and ...

May 21, 2024

Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling medical teams to intervene and avoid hospitalization.

News | FDA

Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

May 17, 2024 — Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has ...

May 17, 2024

Abbott recalls HeartMate 3 left ventricular assist system (LVAS) implant kit for risk of blood leakage or air entering system between inflow cannula and apical cuff

News | FDA

FDA Announces Abbott Recall of HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit

May 15, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling the HeartMate 3 LVAS by ...

May 15, 2024

The US Food and Drug Administration is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices

News | FDA

FDA Notes Safety and Quality Concerns with Getinge/Maquet Cardiovascular Devices

May 8, 2024 — The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our ...

May 08, 2024

News | FDA

4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

May 8, 2024 — 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally ...

May 08, 2024