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Diagnostics & Healthcare News

empowerDX At-Home COVID-19 Testing Kit Receives EUA For Children Three Years And Older

Clinical Enterprise, Inc. d/b/a empowerDX, today announced its at-home COVID-19 testing kit received FDA-emergency use authorization for children three years and older. The direct-to-consumer company, owned by Eurofins Scientific, is the first to receive an EUA for an at-home PCR nasal test...

May 23, 2021

Cardiovascular / Cardiology

TricValve Transcatheter Bicaval Valves System Receives CE Mark

OrbusNeich Medical Company Ltd. and P&F Products & Features, under the joint partnership OrbusNeich P&F, today announced that the TricValve® Transcatheter Bicaval Valves System has received CE mark approval. The TricValve Transcatheter Bicaval Valve (bioprosthesis) is developed for the treatment...

May 23, 2021

Diagnostics & Healthcare News

Neurolutions Receives FDA De Novo Market Authorization for IpsiHand Robotic Stroke Rehab System

Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today that the U.S. Food and Drug Administration (FDA) granted De Novo market authorization for its...

May 9, 2021

Diagnostics & Healthcare News

Smiths Medical and Ivenix Partner to Revolutionize Infusion Management with First-Ever Comprehensive Suite of Infusion Solutions in US Healthcare Market

Bolstered by strategic investment from Smiths Medical, commercial partnership will offer best-in-class infusion systems designed to improve patient safety, advance clinical efficiency Smiths Medical, a global medical device leader, today announced it has formed an exclusive partnership with Ivenix, Inc....

May 9, 2021

Orthopedics and Spine

Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD). The...

May 2, 2021

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