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Quanterix gets FDA EUA status for Simoa SARS-CoV-2 N protein antigen test

Quanterix has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Simoa SARS-CoV-2…

Biotricity to introduce new personal heart monitor Bioheart

Medical diagnostic and consumer healthcare technology firm Biotricity is set to introduce a new personal heart monitor called Bioheart. The…

Quanta gets FDA nod for SC+ haemodialysis system

British medical technology firm Quanta Dialysis Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for…

Everlywell to distribute Access Bio’s CareStart Covid-19 antigen test

Digital health company Everlywell has entered into a distribution agreement with life sciences company Ginkgo Bioworks on the Covid-19 antigen…

Tidepool completes FDA 510(k) submission of Tidepool Loop

Tidepool, a 501(c)3 nonprofit, today announced completion of its FDA submission of Tidepool Loop, an automated insulin dosing app intended…

PerkinElmer to buy diagnostics firm Oxford Immunotec Global for $591m

PerkinElmer has agreed to acquire diagnostics company Oxford Immunotec Global in a deal valued at around $591m. The acquisition is…

Transmission ultrasound breast imaging to become available in EMEA markets

QT Imaging, developer of the QTscan, has selected Freedom Ventures B.V., as the exclusive distributor of its 3D breast imaging…

Pi-Cardia successfully treats first patients with ShortCut device

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today successful first-in-human…

Spectrum Solutions gets CE mark for SDNA saliva collection device

Spectrum Solutions has secured CE mark approval for its SDNA-2000 and SDNA-3000 saliva collection devices for IVD molecular diagnostic testing…

KAIST Mobile Clinic Module to relieve demand for negative pressure beds

The MCM expects to quickly meet the high demand for negative pressure beds in the nation and eventually many other…