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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 17, 2020

View Archived Issues
Coronavirus vs US

FDA’s Stenzel: Agency willing to be ‘very flexible’ for at-home COVID-19 test

The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said. Read More
Rocket launch illustration

Olive Diagnostics emerges from stealth with AI-assisted home urinalysis device

Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app. Read More
Vocus PTR-TOF in the hospital

French researchers test new breath test to detect COVID-19

PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection. Read More
Australia map and flag with double helix

Australia creates first national COVID-19 tracking system using genomics to track virus signature

PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology. Read More
NYSE-new-york-stock-exchange-building.png

U.S. lawmakers look to close trading loopholes

Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal. Read More
Muscle fibers

RNA-targeted CRISPR reverses myotonic dystrophy symptoms

Researchers at the University of California at San Diego have used RNA-targeted CRISPR to reverse symptoms in an animal model of myotonic dystrophy type 1 (DM1). They reported their findings in the Sept. 14, 2020, issue of Nature Biomedical Engineering. Read More

Appointments and advancements for Sept. 17, 2020

New hires and promotions in the med-tech industry, including: Biofidelity, Coremedix, Dentsply. Read More

Financings for Sept. 17, 2020

Med-tech firms raising money in public or private financings, including: Microbix Biosystems, Nyxoah, RapidAI. Read More

In the clinic for Sept. 17, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Lumos Diagnostics, Theranica. Read More

Other news to note for Sept. 17, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Aesculap, Bioporto, Healthvana, Henkel, Keystone Industries, Medasense, Mimedx, Neumodx Molecular, Personalis, Prevencio, Qiagen, Scipher Medicine, Siemens Healthineers, StreamMD, True Digital Surgery, Walgreens. Read More

Regulatory actions for Sept. 17, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 410 Medical. Read More

Regulatory front for Sept. 17, 2020

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Palmetto GBA, Senseonics. Read More

BioWorld MedTech’s Diagnostics Extra for Sept. 17, 2020

Keeping you up to date on recent developments in diagnostics, including: Intensive care scoring systems outperform miRNA in sepsis diagnosis; Report: AI falls short of potential in health care; Angiopoietin trouble can lead to lymphedema. Read More

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