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FDA approves Boston Scientific’s Rebel coronary stent system 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
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

Latest News and Insight by Sector

Specialty Devices

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
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Diagnostics

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
See more

Patient Care

Summit Medical obtains FDA approval for additional sterilization cycles
By MDBR Staff Writer
Summit Medical, a US-based medical device manufacturer, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for sterilization methods on the company’s Instru-Safe instrument protection trays.
Patient Care > Surgical & Supplies > News
Osiris Therapeutics launches additional sizes of Grafix
By MDBR Staff Writer
Osiris Therapeutics, a US-based stem cell company, has expanded its Grafix product portfolio with the launch of several new sizes.
Patient Care > Wound Care Management > News
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Technology

DICOM Grid secures $6m to meet growing demand for digital medical imaging in cloud
DICOM Grid has announced a $6m inside funding round backed by Canaan Partners, CHL Medical Partners, Mayo Clinic and several individual investors.
Technology > Healthcare IT > News
Brainlab releases Elements automatic brain metastases planning software
By MDBR Staff Writer
Brainlab, a manufacturer of software-driven medical technology, has introduced Elements automatic brain metastases planning software that will simplify stereotactic radiosurgery planning for metastatic brain tumors.
Technology > Healthcare IT > News
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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.
Contract Services > 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.
Patient Care > Surgical & Supplies > News
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Certification

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.
Certification > News
Cothera receives ISO 13485 certification
Cothera, a global medical device manufacturer, has announced that it has received ISO 13485:2012 certification.
Certification > News
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