Latest Medical Devices News
NewCardio Signs Agreement With US CRO For QTinno
NewCardio, a cardiac diagnostic technology provider, said that a US based CRO that provides early phase and specialty clinical drug development services to the pharmaceutical industry, has signed an MSA, licensing NewCardio's QTinno software solution to deliver fully automated cardiac safety analysis in early phase QT studies.
Published: 19-Mar-2010
Spinal Restoration Initiates Enrollment For Phase III Study Of Biostat System
Spinal Restoration has initiated patient enrollment in the Phase III study of the Biostat System for the treatment of discogenic chronic low back pain.
Published: 19-Mar-2010
Promega Receives CE Mark For Maxwell 16 IVD System
Promega has received CE mark for Maxwell 16 IVD system, in accordance with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. The CE mark applies to the instrument, the Maxwell 16 Blood DNA Purification System and the Maxwell 16 Viral Total Nucleic Acid Purification System.
Published: 19-Mar-2010
Philips Electronics, Definiens To Jointly Develop Digital Pathology Solutions
Royal Philips Electronics and Definiens, a Germany-based company specializing in image analysis solutions, have signed a memorandum of understanding (MOU)to jointly develop and market clinical decision support solutions for digital pathology.
Published: 19-Mar-2010
EndoChoice Initiates CEU Program On Proper Endoscope Reprocessing
EndoChoice, a designer, manufacturer and marketer of gastrointestinal endoscopy devices, has strengthened its position in endoscopy industry with the launch of a new CEU program and a complete line of products focused on endoscope reprocessing.
Published: 18-Mar-2010
FDA Recommends Expanded Indication For Boston Scientific Heart Failure Devices
Boston Scientific, a developer, manufacturer and marketer of interventional medical devices, has reported that the Circulatory System Devices Panel of the FDA has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS CRT-D.
Published: 18-Mar-2010
Atritech Presents FDA Regulatory Update
Atritech, a Minnesota-based privately held medical device company, has obtained clarity from the FDA on the regulatory path towards full approval of its Watchman Left Atrial Appendage (LAA) Closure Technology in the US.
Published: 18-Mar-2010
Solos Endoscopy Receives US Trademark For MammoView
Solos Endoscopy, a healthcare instrument that develops and markets devices for screening, diagnosis, treatment and management of medical conditions, has secured US Trademark for MammoView name, a breast endoscopy system that offers technology for detecting early stage breast cancer.
Published: 18-Mar-2010
Cascade Technologies Acquires Spectral Molecular Imaging
Cascade Technologies has acquired privately-owned, Los Angeles-based medical device developer Spectral Molecular Imaging (SMI) for stock.
Published: 18-Mar-2010
Medtronic Receives FDA Approval For New Diabetes Management System
Medtronic has received FDA approval for MiniMed Paradigm REAL-Time Revel System, an integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.
Published: 18-Mar-2010
