FDA

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

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

The approval is based on the results of SELECT, the largest cardiovascular outcomes trial ever completed for people with obesity and known heart disease

News | FDA

FDA Approves Wegovy for Cardiovascular Risk Reduction in Adults with Known Heart Disease and Overweight or Obesity

March 8, 2024 — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional ...

March 08, 2024

CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events

News | FDA

Biocardia Reports Positive Interim Results from Phase III Cardiamp Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

March 7, 2024 — BioCardia, Inc. , a biotechnology company focused on advancing late-stage cell therapy interventions for ...

March 07, 2024

Company’s AI-enabled technology for future heart attack risk assessment accepted into FDA’s TAP Pilot and to be validated in landmark TRANSFORM trial

News | FDA

Cleerly Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

March 6, 2024 — Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart ...

March 06, 2024

Ensight-AI, a Yale start-up and leader in AI-based cardiovascular diagnostics, announces the receipt of the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation for their ECGvision-TTR Technology

News | FDA

Ensight-AI Awarded FDA’s Breakthrough Device Designation for Its ECGVision-TTR Technology for Early Detection of ATTR-Cardiomyopathy

March 6, 2024 — Ensight-AI, a Yale start-up and leader in AI-based cardiovascular diagnostics, announces the receipt of ...

March 06, 2024

Lantheus announced that the U.S. Food and Drug Administration (FDA) has approved DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms, including those who have undergone heart transplant, or have Kawasaki disease or a congenital cardiovascular anomaly.

News | FDA

Lantheus Announces the FDA Approval of DEFINITY as Ultrasound Enhancing Agent for Use in Certain Pediatric Cardiovascular Patients

March 6, 2024 — Lantheus Holdings, Inc. (Lantheus), a radiopharmaceutical company, has announced that the U.S. Food and ...

March 06, 2024

First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence

News | Drug-Eluting Balloons

Boston Scientific Receives FDA Approval for the AGENT Drug-Coated Balloon

March 1, 2024 — Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration (FDA) ...

March 01, 2024

Next-generation skin patch-based monitoring platform enables complete freedom of movement for patients in both healthcare and home settings

News | Wearables

X-trodes Receives FDA 510(k) Clearance for Wearable "Skin" Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home

February 20, 2024 — X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment ...

February 20, 2024

Panel of independent experts reviewed data from the TRILUMINATE pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system

News | Structural Heart

FDA Advisory Committee Votes in Favor of Abbott’s First-of-its-kind Triclip System to Treat People with a Leaky Tricuspid Heart Valve

February 15, 2024 — Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee ...

February 15, 2024

Butterfly iQ3 is built on the next-generation P4.3 Ultrasound-on-Chip technology with the world’s fastest digital data transfer, enhancing frame rates, frequency and new 3D imaging capabilities – all on a smaller, lighter and more ergonomically designed probe

News | Point-of-Care Ultrasound (POCUS)

Butterfly Network Launches Next-Generation Butterfly iQ3 in the United States

February 13, 2024 — Butterfly Network, Inc., a digital health company transforming care through the power of portable ...

February 13, 2024

The brain has about 100 billion cells called neurons. It’s made up of distinct parts, that developed though human evolution. Copyright American Heart Association

News | Stroke

Nerve Stimulation Plus Intense Rehab May Improve Arm and Hand Function After Stroke

February 7, 2024 — Combining brain stimulation with intense physical rehabilitation helped stroke survivors recover ...

February 07, 2024

ATTRibute-CM results also demonstrated rapid clinical benefit on the composite endpoint of all-cause mortality (ACM) and CVH in patients treated with acoramidis, with time-to-first event Kaplan-Meier curves separating at month 3 and continuing to diverge steadily through Month 30

News | FDA

BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

February 6, 2024 — BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and ...

February 06, 2024

The American College of Cardiology’s Cardiac Oncology Conference, “Advancing the Cardiovascular Care of the Oncology Patient,” will be held at the Heart House in Washington, D.C., from Feb. 9-11, 2024

News | ACC

American College of Cardiology (ACC) Program Set for Cardiac Oncology Conference, “Advancing the Cardiovascular Care of the Oncology Patient”

February 2, 2024 — The American College of Cardiology’s Cardiac Oncology Conference, “Advancing the Cardiovascular Care ...

February 02, 2024