The FDA issued a letter agreeing with Abbott (NYSE:ABT) that the company’s IgG antibody test should be supplemented with a second, independent test. The letter, dated Dec. 1, 2020, states that the FDA concurs with the additional statement to Abbott’s fact sheet for healthcare providers which outlines the risk of false-positve results. FDA received the supplement […]
COVID-19
Everlywell raises $175M
Everlywell announced today that it completed an oversubscribed Series D financing round, bringing in proceeds of $175 million. Austin, Texas-based Everlywell’s latest round included new investors such as BlackRock, The Chernin Group (TCG), Foresite Capital, Greenspring Associates, Lux Capital, Morningside Ventures, and Portfolia, as well as existing investors Goodwater Capital, Highland Capital Partners, and Next […]
Drawbridge Health, Cambridge partner for COVID-19 remote blood sample collection study
Drawbridge Health announced today that it has partnered with the University of Cambridge (UK) to use the OneDraw blood collection device for detecting COVID-19. Melo Park, Calif.-based Drawbridge and Cambridge’s Medical Research Council (MRC) epidemiology unit are using the OneDraw device for remote blood-sample collection in a large-scale surveillance study for assessing the prevalence of […]
Chembio lands $12.7M from BARDA for point-of-care test
Chembio Diagnostics (NSDQ:CEMI) announced that it received a $12.7 million contract from BARDA for its rapid COVID-19 test. Hauppauge, N.Y.-based Chembio said in a news release that the contract will support the development of and pursuit of FDA emergency use authorization (EUA) for its rapid, multi-plex DPP respiratory antigen panel point-of-care testing system ahead of […]
BREAKING: U.K. approves Pfizer and BioNTech’s COVID-19 vaccine
The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to evaluate […]
COVID-19 drives sales outlook boost for Vapotherm
VapoTherm (NYSE:VAPO) yesterday released an update increasing its financial guidance for the fourth quarter of fiscal 2020. In November, the Exeter, N.H.-based respiratory distress treatment developer projected fourth-quarter revenues ranging between $18 million and $20 million, bringing its full-year revenue guidance to between $102.8 million and $104.8 million. That marked an anticipated year-over-year increase of between […]
How ResMed is advancing sleep and respiratory care
The COVID-19 pandemic’s propulsion of widespread telehealth adoption has ResMed (NYSE:RMD) eyeing remote technologies for the next phase of its sleep and respiratory businesses. The president of that business for the San Diego-based company, Jim Hollingshead, told Medical Design & Outsourcing in a recent interview that the future lies with remote care and digital health offerings. “Right before the […]
Genetworx Labs launches COVID-19/flu/RSV diagnostic test
Genetworx Labs announced today that it launched a diagnostic flu A-B/COVID-19/RSV combination test that uses just one sample. Glen Allen, Va.-based Genetworx Labs’ Combo PCR test offers the ability to detect strands of influenza A and B, RSV and COVID-19 within the same sample, according to a news release. The molecular diagnostic PCR test has […]
Medtronic and its foundation donate $3.8M more to COVID relief
Medtronic (NYSE:MDT) and the Medtronic Foundation announced a commitment of $3.8 million in support of COVID-19 relief. The $3.8 million donation is earmarked for providing healthcare workers support and protection, as well as including mental heatlh support, operational support and food assistance to communities and organizations in need, adding to a $10 million pledge made at […]
Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
Boston Scientific (NYSE:BSX) made waves this month when it recalled and retired its Lotus TAVR product line. Subsequent layoffs, first in Minnesota, then in Ireland, highlighted the impact of the decision to pull Lotus from the highly competitive market as a result of complexities related to the product delivery system and solely that — as the […]
FDA allows dry heat treatment for single-user mask reuse
The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
