Posts by rw-admin
Latest iCad 3D Mammography AI Gains CE Mark
iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval. Compared to previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining an industry-leading high sensitivity…
Read MoreSpino Modulation Vertebral Body Tethering Device Wins FDA Breakthrough Device Designation
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely…
Read MoreCognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid
Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to…
Read MoreAliveCor Purchases CardioLabs
AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s mission to extend its comprehensive cardiological services to patients who are prescribed monitoring devices by…
Read MoreempowerDX 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…
Read MoreQorvo 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…
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