Tag: FDA

Micro Medical Solutions Receives FDA Breakthrough Device Designation for MicroStent Vascular Stent

Breakthrough Designation Helps Advance Treatment Options, Targeting a Significant Unmet Need in the Treatment of CLTI. WILMINGTON, Mass., May 4, 2021 /PRNewswire/ — Micro Medical Solutions (MMS), an emerging leader in the treatment of CLTI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its […]

AtriCure’s EPi-Sense System Approved by FDA for Treatment of Long-Standing Persistent Afib Patients

FDA approval results in the only label of its kind for more than 3 million patients in the United States, significantly expanding AtriCure’s addressable market Superiority trial showed a 29% difference in effectiveness at 12 months and a 35% difference in effectiveness at 18 months for long-standing persistent Afib patients. Study […]

FDA Clears IMS CloudVue for Mobile 3D with Patented Cinematic Rendering

Giving IMS a First Mover Advantage – The Only 100% Cloud-Based FDA Cleared Cinematic Solution on the Market TORONTO, April 28, 2021 /PRNewswire/ — International Medical Solutions (“IMS”), one of the first cloud-native technologies to enable the remote, seamless, and instant view of medical DICOM images in the cloud received FDA Class II […]

Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System™

Patient Enrollment to Begin Within Three Months FREMONT, Calif. and OXFORD, United Kingdom, April 21, 2021 /PRNewswire/ — Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour […]

Medtronic Receives U.S. FDA Approval for Pipeline™ Flex Embolization Device with Shield Technology™

First Patient Receives New Shield Surface Modification, An Advance in Flow Diversion Therapy, at NYU Langone Health DUBLIN, April 21, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline™ Flex Embolization Device […]

LivaNova Receives FDA 510(k) Clearance for B-Capta, the New In-Line, Blood-Gas Monitoring System Integrated Into the S5 Heart-Lung Machine

Intuitive, optical-based technology system now available around the world LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading S5® heart-lung machine (HLM). The system is […]

AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System

Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology today announced that on April 9, 2021, it […]

TransMedics Announces Positive FDA Advisory Committee Vote for OCS Heart System

Panel votes 12 to 5 that benefits of OCS Heart System outweigh risks ANDOVER, Mass., April 6, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today that after the review of TransMedics’ clinical […]

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract SILVER SPRING, Md., March 26, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult […]

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]