1043 articles by Nick Paul Taylor
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UK extends OK of Innova COVID-19 test criticized by FDA in warning letter
June 18, 2021 -
FDA seeks feedback on distinction between device remanufacturing and servicing
June 18, 2021 -
LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors
June 16, 2021 -
MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire
June 16, 2021 -
FDA advisory panel to review TransMedics' liver preservation device
June 15, 2021 -
Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study
June 15, 2021 -
FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device
June 14, 2021 -
EC issues medtech guidance on implant cards required under MDR
June 14, 2021 -
FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling
June 11, 2021 -
Medtronic's FDA approval sets up fight for recharge-free pain market
June 11, 2021 -
EU provides plan to meet 'serious challenge' of readiness for IVDR
June 10, 2021 -
Amazon offers COVID-19 test online to consumers with a website for viewing results
June 9, 2021 -
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
June 8, 2021 -
Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains
June 8, 2021 -
Cancer tech dominates FDA's latest batch of breakthrough devices
June 7, 2021 -
Grail starts selling multi-cancer liquid biopsy Galleri in the US
June 7, 2021 -
Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott
June 4, 2021 -
FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities
June 3, 2021 -
Cognoa's machine learning software for autism diagnosis gets FDA nod
June 3, 2021 -
Abiomed buys preCARDIA to bag breakthrough heart failure device
June 2, 2021 -
FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production
June 1, 2021 -
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
June 1, 2021 -
Swiss medtech sounds alarm as MDR erects barriers to EU market
May 28, 2021 -
Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial
May 28, 2021 -
Analysts tip Edwards' US TAVR growth at 90% in April
May 27, 2021