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Roche Diagnostics

Roche to compete against Abbott with fast COVID-19 antigen tests

September 2, 2020 By Chris Newmarker

Roche (SWX: RO,  ROG) plans to launch a SARS-CoV-2 rapid antigen test that doesn’t need lab equipment to process results — similar to the test that Abbott (NYSE:ABT) recently launched. Roche’s test will launch late this month in Europe, initially making 40 million tests available per month. The Swiss pharma and diagnostics giant plans to also […]

Filed Under: Diagnostics, Featured Tagged With: Abbott, coronavirus, COVID-19, Roche, Roche Diagnostics

AdvaMed unveils COVID-19 diagnostic supply registry

July 21, 2020 By Sean Whooley

AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses. According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, […]

Filed Under: Business/Financial News, Diagnostics, Featured Tagged With: Abbott, AdvaMed, Beckman Coulter Inc., becton dickinson, Bio-Rad, BioMerieux Inc., Cepheid, coronavirus, COVID-19, Hologic, Ortho Clinical Diagnostics, Qiagen N.V., Roche Diagnostics, Sekisui Chemical Co. Ltd., Siemens Healthineers, Thermo Fisher Scientific

Roche Diagnostics win FDA EUA for COVID-19 antibody test

May 4, 2020 By Danielle Kirsh

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 […]

Filed Under: Blog Tagged With: coronavirus, COVID-19, Roche Diagnostics

Roche secures emergency use authorization for coronavirus test

March 13, 2020 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, FDA, Roche, Roche Diagnostics

FDA doubles down on warfarin test strip recall

February 5, 2019 By Sarah Faulkner

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 […]

Filed Under: Diagnostics, Featured, Pharmaceutical, Recalls, Regulatory/Compliance, Vascular Tagged With: Roche Diagnostics

FDA issues Class I recall for Roche Diagnostics’ warfarin test strips

November 2, 2018 By Sarah Faulkner

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 […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Pharmaceutical, Recalls, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Roche Diagnostics

DeviceTalks Q&A: Regulatory experts talk medtech policy

July 7, 2017 By Sarah Faulkner

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Boston Scientific, CHF Solutions Inc., Roche Diagnostics

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