Baxter (NYSE:BAX) and Biomérieux (EPA:BIM) today announced CE mark approval for their Nephroclear CCL14 test. The companies designed the Nephroclear CCL14 test to predict persistent severe acute kidney injury (PS-AKI). It can be used to support timely clinical decision-making and care pathways, according to a news release. Baxter and Biomérieux plan to launch Nephroclear CCL […]
BioMerieux Inc.
FDA permits marketing of first COVID-19 diagnostic test through premarket review process
The FDA announced that it granted marketing authorization to Biomérieux subsidiary BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test. Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the de novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according […]
DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production
The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test. Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release. BioFire’s COVID-19 test received FDA emergency use authorization […]
AdvaMed unveils COVID-19 diagnostic supply registry
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, […]
Baxter, Biomérieux ink acute kidney injury biomarker dev deal
Baxter (NYSE:BAX) said today that it inked a partnership deal with Biomérieux looking to develop biomarkers to identify acute kidney injury. The partnership was announced at the International Symposium on Intensive Care and Emergency Medicine, Deerfield, Ill.-based Baxter said. Both companies said they hope to develop the biomarkers to help rapidly identify and inform treatment of acute […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal […]
These 10 medtech companies care a lot about research
Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced? Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in […]
BG Medicine puts a new man in the corner office | Personnel Moves
Eric Bouvier took over the corner office at BG Medicine (NSDQ:BGMD) yesterday as president & CEO of the Waltham, Mass.-based diagnostics developer.
Prior to joining BG, Bouvier, 51, headed the Immunoassay business at global diagnostics company BioMérieux. He also held the role of president & CEO of BioMérieux’s U.S. subsidiary bioMerieux Inc.
Stents: Boston Scientific’s Promus DES wins FDA clearance | Regulatory Roundup
Boston Scientific Corp.’s (NYSE:BSX) Promus Element drug-eluting stent for small vessels won a nod from the FDA and BSX earned a ratings upgrade from investment bank Goldman Sachs.
The Natick, Mass.-based medical device maker said FDA regulators approved its Promus everolimus-eluting coronary stent for use in vessels as small as 2.25mm in diameter. The company said it plans to immediately launch the product in the U.S.
BioMérieux expands global recall for anti-bacterial tests
BioMerieux Inc. expanded its worldwide recall of a test for certain bacterias’ resistance to a type of antibiotic.
The French French medical diagnostics maker’s Vitek 2 Gram Negative Susceptibility Cards designed to test bacteria for susceptibility to the antibiotic Piperacillin/Tazobactam (TZP) were found to provide inaccurate results.
