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Cepheid

Cepheid wins EUA for COVID-19, flu, RSV combination test

September 29, 2020 By Sean Whooley

Cepheid announced today that it received FDA emergency use authorization for its Xpert Xpress SARS-CoV-2/Flu/RSV diagnostic test. The Danaher Corp. (NYSE:DHR) subsidiary’s rapid molecular diagnostic test for detecting the viruses causing COVID-19, Flu A, Flu B and RSV infections in a single patient can be used in tandem with any of Cepheid’s GeneXpert systems across the […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Cepheid, coronavirus, COVID-19, Danaher Corp., FDA

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

Cepheid wins emergency use nod from FDA for bedside coronavirus test

March 23, 2020 By Sean Whooley

Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak. The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: Cepheid, coronavirus, COVID-19, Danaher Corp., FDA

Danaher to buy Cepheid in $4B deal to expand in diagnostics

September 6, 2016 By MassDevice

(Reuters) –Danaher Corp. (NYSE:DHR) said on Tuesday it would buy molecular diagnostics company Cepheid in a deal valued at $4 billion, including debt, to strengthen its diagnostics business. Danaher will pay $53 per share in cash, a premium of 54% to Cepheid’s close of $34.42 on Friday. Danaher, which develops technology for the dental, life […]

Filed Under: Business/Financial News, Mergers & Acquisitions Tagged With: Cepheid, Danaher Corp.

FDA approves spine sealant from Covidien | Regulatory roundup

April 15, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the FDA and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Aethlon Medical Inc., Cepheid, Covidien, Delcath Systems Inc., GE Healthcare, Integra LifeSciences, stjudemedical, ThermoGenesis Corp., XDx Inc.

Earnings roundup: Thoratec profits leap 58 percent

January 28, 2011 By MassDevice staff Leave a Comment

MassDevice.com Earnings Roundup

MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.

Here’s a quick rundown of a few releases over the past couple days:

Filed Under: Business/Financial News, MassDevice Earnings Roundup, News Well Tagged With: Abaxis Inc., Accuray Inc., Alcon, Cepheid, dextera, Omnicell Inc., ResMed Inc., SOLOS Endoscopy Inc., Thoratec Corp., Uroplasty Inc., Zoll Medical

Cepheid’s Q4 sales rise, net loss falls

January 29, 2010 By MassDevice staff Leave a Comment

Cepheid (NSDQ:CPHD) posted fourth-quarter sales of $49.2 million for the three months ended Dec. 31, 2009, up 30.1 percent compared with $37.8 million during the same period in 2008. Cepheid pared its net loss for the quarter by 29.2 percent to $4.3 million, compared with $6.1 million during Q4 2008:

Press Release

Cepheid Reports Fourth Quarter and Full Year 2009 Results
 
Test Menu Expansion Drives Full Year Clinical Business Growth of 28%

Filed Under: Business/Financial News, Diagnostics, Genomics/Molecular Diagnostics, MassDevice Earnings Roundup, News Well Tagged With: Cepheid

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