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1-15 of 13956 results
VuCOMP receives market clearance for M-Vu breast density in Canada
VuCOMP has announced that it has amended its Health Canada Medical Device License to include M-Vu Breast Density.
Diagnostics > Diagnostic Imaging > News
Teleflex receives FDA clearance for ARROW-Clark VectorFlow chronic hemodialysis catheter
Teleflex, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its ARROW-Clark VectorFlow Chronic Hemodialysis Catheter.
Specialty Devices > Cardiovascular Devices > News
Miracor Medical Systems launches PICSO impulse system for treatment of myocardial infarction
Miracor Medical Systems announced the successful launch of its next-generation PICSO Impulse System for the treatment of myocardial infarction.
Specialty Devices > Cardiovascular Devices > News
Vittamed receives CE Mark approval for two ultrasound-based neuromonitoring devices
By MDBR Staff Writer
Vittamed has obtained CE Mark approval for its Vittamed 205 for non-invasive intracranial pressure (ICP) measurement and for its Vittamed 505 for non-invasive cerebrovascular autoregulation monitoring devices.
News
Boston Scientific announces full commercial launch of Polaris imaging system
By MDBR Staff Writer
Boston Scientific has announced the full commercial launch of the new Polaris imaging system, which supports the company’s family of intravascular ultrasound catheters, including coronary, peripheral and intra-cardiac echo products.
Specialty Devices > Cardiovascular Devices > News
FDA approves Vascular Pathways’ AccuCath 2.25" blood control intravascular catheter
By MDBR Staff Writer
Vascular Pathways has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AccuCath 2.25" blood control intravascular catheter.
Specialty Devices > Cardiovascular Devices > News
St. Jude Medical gets CE Mark approval for FlexAbility ablation catheter
By MDBR Staff Writer
St. Jude Medical, a global medical device manufacturer, has obtained CE Mark approval for its FlexAbility ablation catheter for the treatment of cardiac arrhythmias.
Specialty Devices > Cardiovascular Devices > News
Expanding Orthopedics obtains FDA clearance for FLXfit 3D expandable interbody cage
Expanding Orthopedics, a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgeries, announces that its FLXfit, the world's first 3D expandable interbody cage, is cleared for commercialization in the US.
Specialty Devices > Orthopedic Devices > News
ITC rules redesigned APEX humidifier still infringes ResMed patents
An International Trade Commission (ITC) ruling issued Friday held that, despite a redesign of its iCH CPAP device, Taiwanese device manufacturer APEX continues to infringe ResMed patents in its humidification.
Specialty Devices > Anesthesia & Respiratory Devices > News
Berry Genomics and Illumina co-develop integrated next-generation sequencing system for review and approval by Chinese Regulatory Agency
Berry Genomics announced it has chosen Illumina Inc’s. next-generation sequencing (NGS) technology as the platform on which Berry will secure Chinese Food and Drug Administration (CFDA) regulatory approval for clinical applications, thereby expanding access to NGS-based tests in China.
Diagnostics > In Vitro Diagnostics > News
NEC Display Solutions obtains FDA approval for MD302C6 color diagnostic monitor
By MDBR Staff Writer
NEC Display Solutions of America has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its 30-inch MultiSync MD302C6 LCD wide-screen display for diagnostic review applications in healthcare organizations.
Diagnostics > Diagnostic Imaging > News
OrbusNeich enrolls first patient in MASCOT registry
By MDBR Staff Writer
Hong Kong-based OrbusNeich has enrolled the first patient in the Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry.
Specialty Devices > Cardiovascular Devices > News
FDA approves CorMatrix ECM for Vascular Repair
By MDBR Staff Writer
CorMatrix Cardiovascular has obtained the US Food and Drug Administration’s (FDA) approval for its CorMatrix ECM for Vascular Repair, which is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels.
Specialty Devices > Cardiovascular Devices > News
FDA approves Varian Medical Systems’ Calypso soft tissue Beacon transponder
By MDBR Staff Writer
Varian Medical Systems has received the US Food and Drug Administration’s (FDA) 510(k) approval for the Calypso soft tissue Beacon transponder, which can help enhance the precision of radiotherapy and radiosurgery treatments for cancer.
Diagnostics > Diagnostic Imaging > News
FDA approves Boston Scientific’s Rebel coronary stent system
By MDBR Staff Writer
Boston Scientific has secured approval from the US Food and Drug Administration’s (FDA) for the Rebel platinum chromium coronary stent system for the treatment of coronary artery disease.
Specialty Devices > Cardiovascular Devices > News
1-15 of 13956 results