The Latest Cardiac and Vascular News
– Varian’s CRA system has been designated a “breakthrough device” by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. – Technology being developed will be assessed in clinical studies as a noninvasive treatment for select patients with refractory VT. PALO […]
SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]
The new Zio® monitor is designed to significantly improve patient comfort, while enhanced AI capabilities raise the bar on cardiac arrhythmia detection SAN FRANCISCO, May 24, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced […]
Study Evaluates the Safety and Feasibility of TherOx Supersaturated Oxygen (SSO2) Therapy in STEMI Patients presenting with Cardiogenic Shock CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today the U.S. Food and Drug Administration (FDA) has approved an investigational device […]
New metal-alloy scoring sheath CE Mark cleared for treatment of peripheral artery disease and end stage renal disease. PARK CITY, Utah, May 10, 2021 /PRNewswire/ — Transit Scientific announced it received CE Mark clearance in the European Union for the XO Score® Scoring Sheath Platform to facilitate dilation of stenotic material in the peripheral vasculature […]
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 […]
Remote Patient Monitoring Platform Provides Continuous Vital Sign Measurement and Patient Deterioration Identification Capabilities In Hospital and Home Settings PETAH TIKVA, Israel , May 4, 2021 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its full AI-powered wearable remote patient monitoring platform has received a […]
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 […]
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 […]
MONTREAL–(BUSINESS WIRE)–Soundbite announces FDA 510(k) Approval for SoundBite® Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P). The SoundBite® Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in […]
