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Medical Devices Business Review

Masimo gets FDA approval for Radius-7 wearable rainbow monitor Masimo has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Radius-7 wearable, tetherless and noninvasive rainbow monitor. Patient Care > Patient Monitoring > News
ADL launches urine-based diagnostic test to detect precursor to colorectal cancer By MDBR Staff Writer
Atlantic Diagnostic Laboratories (ADL) announced the official launch of PolypDx, a non-invasive urine-based diagnostic test for detection of adenomatous polyps, the precursor to colorectal cancer. It is estimated that there will be 134,490 new cases reported this year.
Diagnostics > In Vitro Diagnostics > News NDS receives FDA clearance for embedded wireless video receiver in Radiance Ultra displays By MDBR Staff Writer
NDS announced it has received FDA 510(k) clearance for an embedded wireless HD-video receiver to be integrated into an endoscopy display.
Diagnostics > Diagnostic Imaging > News Transplant Genomics enters collaboration with Mayo Clinic By FBR Staff Writer
Transplant Genomics (TGI) is collaborating with the Mayo Clinic Center for Individualized Medicine to develop, validate and commercialize diagnostic tests enabling personalized immunosuppression for solid organ transplant recipients.
Diagnostics > In Vitro Diagnostics > News
Bruker unveils new NMR profiling module for lipoprotein subclass analysis By MDBR Staff Writer
Bruker has unveiled new nuclear magnetic resonance (NMR) profiling module for detailed lipoprotein subclass analysis.
Technology > Healthcare IT > News German researchers create 3D-printed optical lenses By MDBR Staff Writer
Researchers from the Germany’s University of Stuttgart have produced optical lenses by using 3D printing method.
News Masimo gets FDA approval for Radius-7 wearable rainbow monitor By MDBR Staff Writer
Masimo has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Radius-7 wearable, tetherless and noninvasive rainbow monitor.
Patient Care > Patient Monitoring > News

Latest News and Insight by Sector

Specialty Devices

Medtronic to acquire Heartware International for $1.1bn
By MDBR Staff Writer
Irish medical technology firm Medtronic has signed an agreement to acquire US-based HeartWare International for about $1.1bn.
Specialty Devices > Cardiovascular Devices > News
Centric Medical gets 510(k) clearance for Subtalar arthroereisis implant system for foot and ankle
By MDBR Staff Writer
Centric Medical, a division of Life Spine, announced that the US Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the subtalar joint.
Specialty Devices > Orthopedic Devices > News
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Diagnostics

ADL launches urine-based diagnostic test to detect precursor to colorectal cancer
By MDBR Staff Writer
Atlantic Diagnostic Laboratories (ADL) announced the official launch of PolypDx, a non-invasive urine-based diagnostic test for detection of adenomatous polyps, the precursor to colorectal cancer. It is estimated that there will be 134,490 new cases reported this year.
Diagnostics > In Vitro Diagnostics > News
NDS receives FDA clearance for embedded wireless video receiver in Radiance Ultra displays
By MDBR Staff Writer
NDS announced it has received FDA 510(k) clearance for an embedded wireless HD-video receiver to be integrated into an endoscopy display.
Diagnostics > Diagnostic Imaging > News
See more

Patient Care

Masimo gets FDA approval for Radius-7 wearable rainbow monitor
By MDBR Staff Writer
Masimo has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Radius-7 wearable, tetherless and noninvasive rainbow monitor.
Patient Care > Patient Monitoring > News
AtriCure commences FROST cryoanalgesia study
By MDBR Staff Writer
AtriCure, a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management announced the first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn, MI.
Patient Care > Surgical & Supplies > News
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Technology

Bruker unveils new NMR profiling module for lipoprotein subclass analysis
By MDBR Staff Writer
Bruker has unveiled new nuclear magnetic resonance (NMR) profiling module for detailed lipoprotein subclass analysis.
Technology > Healthcare IT > News
Paramit acquires Lathrop Engineering
By MDBR Staff Writer
Paramit, the “zero-defect” medical device and life science contract manufacturer, announced its acquisition of Lathrop Engineering, an instrumentation product development company specializing in medical devices and diagnostics.
Technology > Automation > 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

Intertek announces new services to support claims for eco-friendly medical devices
By MDBR Staff Writer
Intertek, a Total Quality Assurance provider to a range of industries worldwide, is announcing new services to help manufacturers of medical electrical equipment verify their products are environmentally conscious.
Certification > News
Theranos’ lab practices pose risk to patient health, says US regulator
By MDBR Staff Writer
Theranos has received a report from the US Government’s Centers for Medicare & Medicaid Services (CMS) citing non-compliance of the firm’s Newark facility with the regulations of clinical laboratory improvement amendments of 1988 (CLIA).
Certification > News
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