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Covidien obtains FDA 510(k) approval for Kangaroo feeding tube with IRIS technology Covidien has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its camera-equipped Kangaroo feeding tube with Integrated Real-time Imaging System (IRIS) technology, designed to enhance patient safety by providing visualization for a procedure that is currently blinded. Diagnostics > Endoscopy Devices > News
Reverse Medical gets FDA IDE approval for Barrel vascular reconstruction device By MDBR Staff Writer
Reverse Medical has obtained the US Food and Drug Administration (FDA) IDE approval for clinical investigation of its Barrel vascular reconstruction device (VRD).
News Abbott gets FDA 510(k) approval for Architect clinical chemistry Hemoglobin A1c test By MDBR Staff Writer
Abbott has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Architect clinical chemistry Hemoglobin A1c (HbA1c) assay that can help physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.
Diagnostics > In Vitro Diagnostics > News VuCOMP releases M-Vu Breast Density Version 2.0 US-based VuCOMP has announced today that it has released an updated version of its M-Vu breast density, M-Vu Breast Density 2.0.
Diagnostics > Diagnostic Imaging > News
Covidien obtains FDA 510(k) approval for Kangaroo feeding tube with IRIS technology By MDBR Staff Writer
Covidien has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its camera-equipped Kangaroo feeding tube with Integrated Real-time Imaging System (IRIS) technology, designed to enhance patient safety by providing visualization for a procedure that is currently blinded.
Diagnostics > Endoscopy Devices > News ROX Medical completes enrollment in CONTROL-HTN trial ROX Medical has completed enrollment for CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension.
Specialty Devices > Cardiovascular Devices > News Mevion Medical Systems announces distribution partnership with Chiyoda Technol Mevion Medical Systems has announces an agreement with Chiyoda Technol for the exclusive distribution of the MEVION S250 proton therapy system in the Japanese market.
Contract Services > News

Latest News and Insight by Sector

Specialty Devices

ROX Medical completes enrollment in CONTROL-HTN trial
15 April 2014
ROX Medical has completed enrollment for CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension.
Specialty Devices > Cardiovascular Devices > News
Federal court orders preliminary injunction on US sales of Medtronic's CoreValve system
14 April 2014
Edwards Lifesciences has announced that the US District Court for the District of Delaware has granted a preliminary injunction limiting the sale of Medtronic's CoreValve system in the US.
Specialty Devices > Cardiovascular Devices > News
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Diagnostics

Abbott gets FDA 510(k) approval for Architect clinical chemistry Hemoglobin A1c test
15 April 2014 | By MDBR Staff Writer
Abbott has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Architect clinical chemistry Hemoglobin A1c (HbA1c) assay that can help physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.
Diagnostics > In Vitro Diagnostics > News
VuCOMP releases M-Vu Breast Density Version 2.0
15 April 2014
US-based VuCOMP has announced today that it has released an updated version of its M-Vu breast density, M-Vu Breast Density 2.0.
Diagnostics > Diagnostic Imaging > News
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Patient Care

Syneron gets FDA 510(k) clearance for UltraShape system
14 April 2014 | By MDBR Staff Writer
Syneron Medical has received the US Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape system, designed for non-invasive reduction of abdominal circumference via fat cell destruction.
News
ConvaTec launches Esteem+ one-piece ostomy pouch
14 April 2014 | By MDBR Staff Writer
ConvaTec, a medical device company, has launched its new Esteem+ one-piece ostomy pouch with Moldable Technology.
Patient Care > Wound Care Management > News
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Technology

Criterions EHR receives ONC-ACB certification by Drummond
14 April 2014
Criterions EHR version 3.0 has been tested and certified under the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body (ONC-ACB) program.
Technology > Healthcare IT > News
FDA approves Calgary Scientific’s ResolutionMD for diagnosis on mobile devices
08 April 2014 | By MDBR Staff Writer
Calgary Scientific has obtained the US Food and Drug Administration’s (FDA) Class II clearance for ResolutionMD for diagnosis on mobile devices, for all imaging modalities.
Technology > Healthcare IT > News
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Contract Services

Mevion Medical Systems announces distribution partnership with Chiyoda Technol
15 April 2014
Mevion Medical Systems has announces an agreement with Chiyoda Technol for the exclusive distribution of the MEVION S250 proton therapy system in the Japanese market.
Contract Services > News
ReFlow Medical and MicroPort Scientific announce Chinese alliance
09 April 2014
ReFlow Medical has announced that it has signed an exclusive distribution and sales agreement for its suite of peripheral chronic total occlusion (CTO) products with MicroPort Endovascular (MicroPort Endo), a division of MicroPort Scientific, a medical device company in China.
Contract Services > News
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Certification

Criterions EHR receives ONC-ACB certification by Drummond
14 April 2014
Criterions EHR version 3.0 has been tested and certified under the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body (ONC-ACB) program.
Technology > Healthcare IT > News
BrainScope receives ISO 13485 certification
14 April 2014
BrainScope, a medical neurotechnology company, has been successfully certified to ISO 13485:2003, the international standard for comprehensive quality management systems for design and manufacture of medical devices.
Certification > News
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