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Roche acquires DNA sequencing technology company Stratos Genomics

Roche acquires DNA sequencing technology company Stratos Genomics

Roche acquisition of Stratos Genomics : Swiss pharma giant Roche has acquired US-based early-stage DNA sequencing technology company Stratos Genomics for an undisclosed price. The transaction is expected to help Roche advance the development of its nanopore sequencer through the access to Sequencing by Expansion (SBX), Stratos Genomics’ unique chemistry. Roche said that once developed, […]

Nevro’s Senza Omnia SCS system gets CE mark for chronic pain treatment

US medical device company Nevro has secured CE mark approval for its Senza Omnia spinal cord stimulation system (Senza Omnia SCS system) for delivering its HF10 therapy for the treatment of chronic pain. The Omnia system is a new spinal cord stimulation (SCS) platform, which is said to consist of many new components like the […]

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Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19. According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction […]

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Roche launches v-TAC blood gas digital solution

Swiss healthcare company Roche has launched a new blood gas digital solution called Roche v-TAC, which is said to be designed to enhance patient care. The new digital diagnostic solution is said to help clinicians to get better results for arterial blood gas values from patients having respiratory or metabolic abnormalities by using a less […]

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Thermo Fisher, WuXi, Mayo Clinic to develop total antibodies Covid-19 test

US life sciences company Thermo Fisher Scientific said that it will collaborate with China-based WuXi Diagnostics and Mayo Clinic to develop a total antibodies Covid-19 test called the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test. The new antibody test development is said to emerge from an ongoing partnership between the three organizations, which includes […]

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Olympic Ophthalmics gets FDA clearance for iTEAR100 Neurostimulator

US medical technology company Olympic Ophthalmics has secured clearance from the US Food and Drug Administration for its iTEAR100 Neurostimulator. iTEAR100 is an external neurostimulator which has been granted a De Novo request by the FDA to temporarily increase acute tear production in adults by stimulating a cutaneous nerve. Dr Cynthia Matossian, an investigator in […]

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Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system

Abbott has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG lab-based serology blood test, a COVID-19 antibody blood test, on the Alinity i system. The US medical device company will look to ship close to 30 million antibody tests across the world this world across […]

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COVID-19 RT-PCR detection kit : Fosun Pharma secures FDA EUA status

Shanghai Fosun Pharmaceutical (Fosun Pharma) has been granted the emergency use authorization (EUA) status for its COVID-19 RT-PCR detection kit from the US Food and Drug Administration (FDA). Fosun Long March, a fully-owned subsidiary of Fosun Pharma, developed the COVID-19 RT-PCR detection kit which already has a medical device registration certificate from the China National Medical […]

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GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status

COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit. According to the genomic technology company, the kit has been developed to generate accurate and reproducible quality results to help in clinical decision-making […]

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Roche cobas HPV test for cervical screening gets FDA nod for use on cobas 6800/8800 Systems

Swiss healthcare company Roche has bagged approval from the US Food and Drug Administration to use its cobas HPV test on the fully automated cobas 6800/8800 Systems for detecting cervical cancer in women. The cobas HPV test has been designed to detect the presence of high-risk human papillomavirus (HPV) DNA in cervical samples from women […]

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