FDA

Abbott has announced U.S Food and Drug Administration (FDA) approval of its TriClip, a first-of-its-kind device to repair leaky tricuspid heart valve.

Abbott Announces FDA Approval of First-of-its-kind Device to Repair Leaky Tricuspid Heart Valve, TriClip

April 2, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) approved the company's first-of-its ...

April 02, 2024

News | FDA

U.S. FDA Approves Broad New Labels for NEXLETOL and NEXLIZET to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

April 1, 2024 — Esperion announced that the United States Food and Drug Administration (FDA) has approved broad new ...

April 01, 2024

The Evolut FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access

News | FDA

Medtronic Announces FDA Approval of Newest-generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis

March 28, 2024 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug ...

March 28, 2024

Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE Platform among U.S. patients

News | Atrial Fibrillation

Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation

March 28, 2024 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson ...

March 28, 2024

News | FDA

FDA Approves Johnson & Johnson OPSYNVI (macitentan and tadalafil) Single-Tablet Combination for Patients with Pulmonary Arterial Hypertension (PAH)

March 27, 2024 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI – ...

March 27, 2024

Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease.

News | FDA

Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease

March 27, 2024 — Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and ...

March 27, 2024

The largest prospective registry of its kind will build upon clinical data supporting the use of plaque insights to empower clinical decision making for patients with suspected coronary artery disease

News | Artificial Intelligence

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

March 27 2024 — HeartFlow, Inc., a leader in AI-driven healthcare technology, announced the launch of the DECIDE ...

March 27, 2024

WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone

News | FDA

FDA Approves Merck’s WINREVAIR, a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

March 27, 2024 — Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug ...

March 27, 2024

Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity

News | FDA

Avicenna.AI Secures FDA Clearance for Two Healthcare AI Solutions

March 26, 2024 — Medical imaging AI company Avicenna.AI announced that it has received 510(k) clearance from the US Food ...

March 26, 2024

The U.S. Food and Drug Administration (FDA) announced that Abiomed is recalling the Instructions for Use for its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart.

News | FDA

FDA Announces Abiomed Recall of the Instructions for Use for the Impella Left Sided Blood Pumps due to Perforation Risks

March 21, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abiomed is recalling the Instructions for ...

March 21, 2024

The new mobile C-arm automates repositioning during surgery

News | Mobile C-Arms

Siemens Healthineers Announces FDA Clearance of CIARTIC Move Self-Driving Mobile C-arm

March 21, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of the CIARTIC Move, a ...

March 21, 2024

The Freesolve BTK RMS is designed for patients auffering From chronic limb-threatening ischemia (CLTI)

News | Peripheral Artery Disease (PAD)

FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)

March 20, 2024 — Biotronik has been granted Breakthrough Device Designation (BDD) from the US Food and Drug ...

March 20, 2024

First-of-its-kind trial in US shows drug-coated balloons are a superior treatment option for patients undergoing coronary angioplasty

News | Cardiovascular Clinical Studies

BIDMC-led Trial Leads to FDA approval of Coronary Drug-coated Balloons

March 13, 2024 — In the largest randomized clinical trial and first of its kind to date in the United States, a team led ...

March 13, 2024

Getinge has announced the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company’s endoscopic vessel harvesting (EVH) solutions.

News | FDA

Getinge Announces US FDA 510(k) Clearance for Vasoview Hemopro 3 Endoscopic Vessel Harvesting (EVH) solution

March 12, 2024 — Getinge has announced the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of the Vasoview ...

March 12, 2024

The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump stop” command is running. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.

News | FDA

FDA Announces Abbott Recall of HeartMate Touch Communication System for Unintentional Pump Start and Stop

March 12, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its HeartMate Touch ...

March 12, 2024