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In Vitro Diagnostics News

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1-15 of 2968 results
Quidel gets FDA nod for Solana RSV + hMPV assay
By MDBR Staff Writer
Diagnostic testing solutions provider Quidel has secured approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) assay.
Diagnostics > In Vitro Diagnostics > News
Roche gets FDA approval for cobas Zika test
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has approved Roche’s new qualitative nucleic acid test to detect Zika virus in blood donations.
Diagnostics > In Vitro Diagnostics > News
Alere i Influenza A & B 2 rapid molecular test gets FDA clearance
Alere announced that its i Influenza A & B 2 test has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for the detection of influenza A and B infection in children and adults.
Diagnostics > In Vitro Diagnostics > News
Mologic gets CE Mark for BVPro point-of-care diagnostic for patients with bacterial vaginosis
Mologic has received CE mark approval for BVPro, a rapid point-of-care test for patients presenting with symptoms of vaginosis.
Diagnostics > In Vitro Diagnostics > News
Patterson Dental, Align Technology sign distribution deal for intraoral scanning system
Patterson Dental, a business unit of Patterson Companies, and Align Technology have signed a distribution agreement for Align’s iTero Element intraoral scanning system.
Diagnostics > In Vitro Diagnostics > News
Quanterix to launch assays for multiplex biomarker detection
Quanterix announced that it will be expanding its single molecule array or Simoa technology platform portfolio to include the new Quanterix SR-Plex benchtop instrument.
Diagnostics > In Vitro Diagnostics > News
Beckman Coulter Diagnostics announces enhancements to Access 2 immunoassay system
Beckman Coulter Diagnostics has announced the worldwide availability of the Access 2 immunoassay system with enhanced features.
Diagnostics > In Vitro Diagnostics > News
Laminate Medical gets IDE nod from FDA to start clinical study of VasQ device
Laminate Medical Technologies has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start clinical study of the VasQ device.
Diagnostics > In Vitro Diagnostics > News
LimFlow's study of percutaneous deep vein arterialization system meets safety endpoints
Private, venture-backed medical device firm LimFlow announced publication of positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in the July issue of the Journal of Endovascular Therapy.
Diagnostics > In Vitro Diagnostics > News
FDA approves BD’s new immunological diagnostic system
By MDBR Staff Writer
Becton, Dickinson and Company (BD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new immunological diagnostic system.
Diagnostics > In Vitro Diagnostics > News
Quidel to buy Alere’s Triage and BNP businesses for $440m
By MDBR Staff Writer
Diagnostic testing solutions provider Quidel has agreed to acquire Alere’s Triage and BNP businesses for around $440m.
Diagnostics > In Vitro Diagnostics > News
Biocept launches new liquid biopsy test for progesterone receptor detection
Biocept has announced the commercial availability of its new liquid biopsy test for progesterone receptor (PR), which can be used for the detection and monitoring of a key biomarker in the blood of patients with breast cancer.
Diagnostics > In Vitro Diagnostics > News
Promega intends to seek FDA approval for Microsatellite Instability assay
Promega intends to seek US Food and Drug Administration approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions.
Diagnostics > In Vitro Diagnostics > News
Angle’s Parsortix-based blood test shows significant effect in ovarian cancer studies
By MDBR Staff Writer
Liquid biopsy firm Angle’s Parsortix-based blood test has showed a significant effect in the US and European ovarian cancer studies, which include up to 400 patients.
Diagnostics > In Vitro Diagnostics > News
Roche launches cobas MRSA/SA test to target healthcare-associated infections
Roche has announced the CE-IVD launch of the cobas MRSA/SA nucleic acid test for use on the cobas Liat System for the qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) at the point of care.
Diagnostics > In Vitro Diagnostics > News
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