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Life Sciences
Top stories summarized by our editors
10/19/2020

European regulators have given CE mark approval to Becton Dickinson for its BD Multitest 6-color TBNK reagent with BD Trucount tubes, an immune assessment product for patients with COVID-19.

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MassDevice (Boston)
10/19/2020

The Biomedical Advanced Research and Development Authority has awarded Beckman Coulter a contract to develop a fast diagnostic test for multisystem inflammatory syndrome in children, a severe, life-threatening complication linked to COVID-19.

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FierceBiotech
10/19/2020

NEC Oncoimmunity AS and the Oslo University Hospital are working together to develop an artificial intelligence platform to help create a T-cell diagnostic to complement serological tests for COVID-19. "We will design this platform to be future-proof and make it applicable to any future emerging infectious agent that could threaten the global population," said NEC CEO Richard Stratford.

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Oslo University Hospital
10/19/2020

Proteomics International Laboratories has entered a 2-year deal with Medical Horizons SRL that will give the latter the exclusive right to distribute its Promarker D diabetic kidney disease immunoassay in Italy.

10/19/2020

The Centers for Medicare and Medicaid Services announced that, effective Jan. 1, only laboratories that are able to complete high-throughput testing within two days of specimen collection will receive its highest reimbursement rate at $100 per test. Labs that take longer than two days will receive a reimbursement rate of $75 per test.

10/19/2020

Shockwave Medical's Disrupt CAD III trial for its Shockwave Coronary IVL System, which uses intravascular lithotripsy to treat severely calcified cardiovascular disease, showed positive results. The system met efficacy and safety endpoints with a 30-day freedom from major adverse cardiovascular events rate of 92.2%.

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Shockwave Medical
10/19/2020

Researchers from the University of Colorado have created the Acousto Thermal Shift Assay, a device that can detect the protein that causes sickle cell disease by heating a protein sample using ultrasound waves and measuring how it dissolves over time.

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MedGadget
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University of Colorado
10/19/2020

European regulators have given CE mark approval to bioLytical Laboratories for its INSTI COVID-19 rapid test that can deliver results in one minute.

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FDAnews
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bioLytical Laboratories
10/19/2020

European regulators have given CE-IVD mark approval to Specific Diagnostics for its Reveal system, a fast antimicrobial susceptibility testing system.

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Specific Diagnostics
10/19/2020

The FDA has given 510(k) marketing clearance to Gentherm Medical for its ASTOPAD, a patient warming system that is used during surgery to prevent or treat hypothermia.

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FDAnews
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Gentherm Medical