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Sorin receives CE mark approval for Memo 3D ReChord Italy-based medical device company Sorin Group has received CE mark approval for its new mitral valve annuloplasty ring, Memo 3D ReChord. Specialty Devices > Cardiovascular Devices > News
Atossa Genetics receives CE mark for ForeCYTE Breast Aspirator device Atossa Genetics announced it has received certification to Annex II of the European Medical Device Directive (MDD) from its European Notified Body, DQS Medizinprodukte GmbH, which allows Atossa to place the "CE" Mark on the ForeCYTE Breast Aspirator for distribution in the European Union and its member states.
News Gynesonics obtains FDA approval for VizAblate System’s IDE clinical trial By MDBR Staff Writer
Womens healthcare company Gynesonics has secured approval from the US Food and Drug Administration (FDA) to commence a pivotal investigational device exemption (IDE) trial, Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA Trial), for VizAblate System.
News Medtronic introduces Divergence Anterior Cervical Fusion System in US By MDBR Staff Writer
Medical technology company Medtronic has introduced Divergence Anterior Cervical Fusion System in the US, which was developed to treat single-level cervical disc disease.
News
Sorin receives CE mark approval for Memo 3D ReChord Italy-based medical device company Sorin Group has received CE mark approval for its new mitral valve annuloplasty ring, Memo 3D ReChord.
News West Pharmaceutical obtains FDA and CE mark approval for Vial2Bag DC device By MDBR Staff Writer
West Pharmaceutical Services has obtained US FDA 510(k) and CE mark approval for its Vial2Bag DC device.
News ResMed enhances U-Sleep patient management platform By MDBR Staff Writer
ResMed announced a significant improvement to U-Sleep, its premium patient management platform, which allows home medical equipment providers (HMEs) to quickly and effectively manage patients with sleep apnea and respiratory conditions.
News

Latest News and Insight by Sector

Specialty Devices

Medtronic introduces Divergence Anterior Cervical Fusion System in US
By MDBR Staff Writer
Medical technology company Medtronic has introduced Divergence Anterior Cervical Fusion System in the US, which was developed to treat single-level cervical disc disease.
News
Sorin receives CE mark approval for Memo 3D ReChord
Italy-based medical device company Sorin Group has received CE mark approval for its new mitral valve annuloplasty ring, Memo 3D ReChord.
News
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Diagnostics

LabCorp introduces HIV-1 next generation sequencing assay
By MDBR Staff Writer
Laboratory Corporation of America Holdings and Monogram Biosciences, part of the LabCorp Specialty Testing Group, announced the launch of HIV GenoSure Archive , the first laboratory test to help optimize antiretroviral (ARV) drug regimens in virally suppressed HIV patients.
News
US District Court grants Covidien preliminary injunction against Ethicon’s Harmonic ACE+7
By MDBR Staff Writer
Covidien announced that the US District Court for the District of Connecticut has granted a preliminary injunction against Ethicon Endo-Surgery, a Johnson & Johnson company.
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Patient Care

ResMed enhances U-Sleep patient management platform
By MDBR Staff Writer
ResMed announced a significant improvement to U-Sleep, its premium patient management platform, which allows home medical equipment providers (HMEs) to quickly and effectively manage patients with sleep apnea and respiratory conditions.
News
UCSF Medical Center adopts smart dressing for chronic wounds
By MDBR Staff Writer
OSNovative Systems, the maker of self-adaptive wound care dressings, announced that its award-winning ENLUXTRA "Any Wound" dressing has been adopted at the UCSF Medical Center for treating chronic wounds.
News
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Technology

Panasonic to introduce new tablet-based telehealth service
By MDBR Staff Writer
Panasonic Corporation of North America is set to introduce a new tablet-based telehealth service, On4Today, in November.
News
FDA approves remote mobile communication device Dexcom SHARE
By MDBR Staff Writer
Dexcom, a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced that it has received US Food and Drug Administration (FDA) approval for its CGM remote mobile communications device: Dexcom SHARE.
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Contract Services

BSD Medical, Comed Medical Specialties sign distribution agreement for microthermx microwave ablation products
BSD Medical, a provider of medical systems that utilize heat therapy to treat cancer, announced that the company has signed an agreement with Comed Medical Specialties (Comed) for the sales and distribution of the MicroThermX Microwave Ablation (MicroThermX) line of products.
News
Femasys signs distribution agreement with McKesson Medical-Surgical for FemCerv device for diagnosis of cervical cancer
Femasys Inc., an emerging medical device developer of women's healthcare solutions, announced today that it has entered into a nationwide distribution agreement with McKesson Medical-Surgical to sell and distribute Femasys' FEMCERV Endocervical Sampler. FEMCERV collects a tissue sample of a woman's endocervical canal for histological analysis when cervical cancer is suspected.
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Certification

Varian Medical Systems' ARIA oncology information system certified for use to demonstrate Stage 1 and 2 meaningful use of an electronic health record
Varian Medical Systems announced that its ARIA oncology information system has been certified for use to demonstrate Stage 1 and 2 'meaningful use of an electronic health record (EHR).
News
McKesson Specialty Health’s electronic health record and patient portal systems receives 2014 ONC-ACB Certification
iKnowMed electronic health record (HER) (version 6.6.0), iKnowMed Generation 2 (version 2.0), and My Care Plus patient portal (version 3.0), oncology-specific products of McKesson Specialty Health, are all ‘Meaningful Use-ready’ and have received 2014 Edition Complete EHR Certification.
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