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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...

June 20, 2021

Orthopedics and Spine

Spino 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...

June 20, 2021

Diagnostics & Healthcare News

Cognoa 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...

June 6, 2021

Cardiovascular / Cardiology

AliveCor 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...

June 6, 2021

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