Roche Diagnostics has received FDA emergency use authorization (EUA) for its Elecsys Anti-SARS-CoV-2 COVID-19 antibody test. The test will identify antibodies to determine if a person has ever been infected with the coronavirus. The presence of SARS-CoV-2 antibodies in human serum or plasma can also indicate an adaptive immune response. Switzerland-based Roche has begun shipping […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today […]
DeviceTalks Q&A: Regulatory experts talk medtech policy
A panel of regulatory experts convened at DeviceTalks Minnesota this year to chat with MassDevice.com editor Sarah Faulkner. The group of regulatory experts included Danelle Miller, VP of regulatory policy & intelligence at Roche Diagnostics; Megan Brandt, VP of regulatory affairs and quality assurance at CHF Solutions (NSDQ:CHFS); and Mac McKeen, regulatory science fellow at Boston Scientific (NYSE:BSX). Faulkner: We […]
