The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism. Read More
Quanterix Corp., of Billerica, Mass., reported that researchers have developed a COVID-19 antibody test with 1,000 times the sensitivity of current tests using its Simoa bead-based immunoassay platform. Read More
Intersect ENT Inc., of Menlo Park, Calif., saw its revenue for the first quarter of 2020 fall to $19.8 million. That figure compares with $26.7 million for the same period last year, with the COVID-19 pandemic having a significant impact on procedures. Read More
If nothing else, the unfolding coronavirus has advanced the implementation of a wide variety of digital health tools. Panelists at the World Medical Innovation Forum on May 11 explored several current use cases. Read More
Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs. Read More
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Med-tech firms raising money in public or private financings, including: Assure Holdings, Atricure, Axonics Modulation Technologies, Danaher, Dexcom, Tandem Diabetes Care. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Medical Resources, Cook Medical, GT Medical Technologies. Read More
Keeping you up to date on recent developments in oncology, including: New nanoparticle proposed as treatment for a ‘wide range of cancers’; CD163-expressing macrophages a sign of poor outcomes; Mevion inks deal for protons in Texas; PSMA PET-CT show well in study of prostate cancer metastasis. Read More
