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Home » SARS-CoV-2

Articles Tagged with ''SARS-CoV-2''

Other news to note for June 22, 2020

June 22, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agena Bioscience, Avita, Astrazeneca, Caprion-Histogenex, Clinical Logistics, Gendius, Lantheus, Mevion, Microdermics, Natera, National Jewish Health, Novateur Ventures, Nuprobe, Orfit, Progenics, Qualtrics, Thermo Fisher Scientific, Weigao Group.
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Product image
Group testing for COVID-19

Stilla introduces new approach to highly sensitive COVID-19 group testing using digital PCR

June 19, 2020
By Bernard Banga
PARIS – Stilla Technologies SAS, of Villejuif, France, is supplying a new, cost-effective approach for COVID-19 testing by combining its digital polymerase chain reaction (PCR) technology with the group testing method. “This approach greatly increases testing capacity and meets the highest quality standards,” Rémi Dangla, co-founder and CEO of Stilla Technologies, told BioWorld.
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Lexagene CEO in lab

Lexagene's multiplex test gives answers needed to manage second wave of COVID-19

June 18, 2020
By Annette Boyle
Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.
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Other news to note for June 18, 2020

June 18, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Align Technology, American Telemedicine Association, Aramark, Archerdx, Bristol-Myers Squibb, China Medical Holdings, Foxconn, Gelesis, Gingko Bioworks, Harvey Nash, Inivata, Medstar Health, Medtech Innovator, Medtronic, Monitorme, Natera, Nephros, One Medical, Philips, Quest Global, Usgi.
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U.S. FDA headquarters

FDA lays out top priorities for COVID-19 testing, weighs in on asymptomatic screening

June 17, 2020
By Stacy Lawrence
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
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Other news to note for June 17, 2020

June 17, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BGI, BioIQ, Cigna, DNA Genotek, Illumina, Inspire Medical Systems, Lantheus, Metabolon, Nanostring, Orasure, Ortho, Phosphorous, Progenics, Respira, Sd Biosensor, Truvian, Yuyu Pharma.
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Regulatory front for June 17, 2020

June 17, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Chembio.
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Regulatory actions for June 17, 2020

June 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
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Avalon fetal monitor on expectant mother in hospital room

Philips launches wireless, wearable obstetrics monitor under FDA COVID-19 guidance

June 16, 2020
By Stacy Lawrence
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
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Multiple computer screens showing various views of ClewICU software

Clew snags EUA for COVID-19 predictive screening tool

June 16, 2020
By Meg Bryant
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
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