FDA

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 ...

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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  ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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) ...

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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 ...

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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 ...

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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 ...

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