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10/1/2020

Medtronic plans to buy endovascular arteriovenous fistulae developer Avenu Medical. The terms of the deal were not disclosed.

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MassDevice (Boston)
10/1/2020

Novacyt, through its molecule diagnostics division Primerdesign, has signed an agreement to supply COVID-19 testing kits and instrument platforms with the UK's Department of Health and Social Care for a period of up to six months. The contract will include its exsig COVID-19 Direct kits, genesig SARS-CoV-2 Winterplex kits and q16 and q32 Rapid-PCR instrument platforms.

10/1/2020

The WaveWriter Alpha portfolio of spinal cord stimulation systems, which consists of four MRI-conditional, Bluetooth-enabled implantable pulse generators, has been released by Boston Scientific in Europe.

10/1/2020

Quest Diagnostics has launched three test alternatives that US health care providers can choose from to diagnose and differentiate seasonal respiratory infections from COVID-19.

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Quest Diagnostics
10/1/2020

European regulators have given CE mark approval to Becton Dickinson for its rapid, point-of-care SARS-CoV-2 antigen test, for use on the BD Veritor Plus system, that can deliver results within 15 minutes.

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MassDevice (Boston)
10/1/2020

The FDA has given 510(k) clearance to Conformis for its Cordera total hip replacement system that is used to treat severely painful or disabled joints.

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FDAnews
10/1/2020

The FDA has given emergency use authorization to Access Genetics & OralDNA Labs for the OraRisk COVID-19 RT-PCR test that uses saline oral rinse samples.

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MassDevice (Boston)
10/1/2020

European regulators have given CE-IVD mark approval to BioGX BV for its RT-PCR-based test that can simultaneously detect influenza A and B, respiratory syncytial virus and SARS-CoV-2.

10/1/2020

The FDA has expanded its safety investigation of AstraZeneca's COVID-19 vaccine trial, which remains on hold in the US since Sept. 6 after one participant got sick with a rare spinal inflammatory disorder, according to a Reuters report citing three sources with knowledge of the matter. The agency plans to analyze data from earlier trials of other vaccines developed by the same researchers.

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Reuters
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Reuters
10/1/2020

A federal appeals court dismissed a lower court ruling directing AbbVie and Besins Healthcare to disgorge $448 million in profits for allegedly thwarting generic versions of its testosterone replacement drug AndroGel, saying the judge didn't have the authority to make the order. Federal Judge Thomas Hardiman, however, said the lower court was right to find the companies liable for monopolization in association with a patent infringement lawsuit.

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Reuters