Archive for April 2021
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 authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens…
Read MoreZOLL 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). CSA is a serious condition that is often associated with heart failure, coronary artery disease,…
Read MoreActiv 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 visual data and imaging not currently available to surgeons through existing technologies, helping to improve…
Read MoreDonisi 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 can change the lives of millions of people. Our novel technology is now recognized and…
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