Archive for May 2021
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 for young children. empowerDX launched its FDA-authorized at-home COVID test in the fall of 2020…
Read MoreTricValve 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 of caval reflux present in cases of severe tricuspid regurgitation, without removal of the defective…
Read MoreNeurolutions 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 groundbreaking IpsiHand Upper Extremity Rehabilitation System. The IpsiHand System has been cleared for use in…
Read MoreSmiths 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. that positions the companies as the first in the U.S. to offer a comprehensive suite…
Read MoreCerapedics 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 FDA’s Breakthrough Device designation is designed to expedite the development and review of medical devices…
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