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Diagnostics & Healthcare News
Qorvo Biotechnologies Receives FDA Emergency Use Authorization for Rapid COVID-19 Antigen Testing
Qorvo, a leading provider of innovative radio frequency (RF) solutions that connect the world, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The test is...
April 18, 2021
Diagnostics & Healthcare News
ZOLL Medical Corporation Acquires Respicardia
ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA)....
April 18, 2021
Imaging Visualization & Navigation
Activ Surgical Announces FDA Clearance for ActivSight Enhanced Surgical Visualization Device
Activ Surgical, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging module has been designed to provide surgeons real-time intraoperative...
April 11, 2021
Diagnostics & Healthcare News
Donisi Wins De Novo Clearance for Contact-Free AI System that Spots Changes in Heart, Breathing Patterns
The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market. “I’m really proud of our team; we developed a medical device that...
April 11, 2021
Cardiovascular / Cardiology
Rapid Medical Receives FDA Clearance for the First Adjustable Stent Retriever for Use in Ischemic Stroke Treatment
Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER™ revascularization device for use in the treatment of ischemic stroke. TIGERTRIEVER is the first stent retriever to offer intelligent control, enabling neuro interventionalists to better remove blood...
March 28, 2021
Orthopedics and Spine
SeaSpine Acquiring 7D Surgical for $110M
SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it has entered into an agreement to acquire all of the issued and outstanding shares of 7D Surgical, Inc.,...
March 28, 2021
Orthopedics and Spine
Catalyst OrthoScience Receives FDA 510(k) Clearance of Its Reverse Shoulder System
Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received clearance from the U.S. Food & Drug Administration (FDA) to market its reverse shoulder system. Catalyst expects to begin a limited user release in...
March 21, 2021
Cardiovascular / Cardiology
Qardio Lands 510(k) for Ambulatory ECG Device
Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.  QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio’s cloud-based remote patient monitoring solution....
March 21, 2021
Cardiovascular / Cardiology
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The...
March 21, 2021
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