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coronavirus

Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.

Drawbridge Health, Cambridge partner for COVID-19 remote blood sample collection study

December 3, 2020 By Sean Whooley

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 […]

Filed Under: Blood Management, Diagnostics, Featured Tagged With: coronavirus, COVID-19, drawbridgehealth, University of Cambridge

Chembio lands $12.7M from BARDA for point-of-care test

December 2, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Contract Manufacturing, Diagnostics, Funding Roundup, Genomics/Molecular Diagnostics Tagged With: Chembio Diagnostics, coronavirus, COVID-19, U.S. Biomedical Advanced Research and Development Authority (BARDA)

BREAKING: U.K. approves Pfizer and BioNTech’s COVID-19 vaccine

December 2, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, Medicines & Healthcare products Regulatory Agency (MHRA), Pfizer

COVID-19 drives sales outlook boost for Vapotherm

December 2, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, MassDevice Earnings Roundup, Respiratory, Wall Street Beat Tagged With: coronavirus, COVID-19, Vapotherm

How ResMed is advancing sleep and respiratory care

December 1, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, MassDevice Earnings Roundup, Patient Monitoring, Research & Development, Respiratory, Wall Street Beat Tagged With: coronavirus, COVID-19, ResMed

Genetworx Labs launches COVID-19/flu/RSV diagnostic test

December 1, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Genomics/Molecular Diagnostics Tagged With: coronavirus, COVID-19, Genetworx Labs

Medtronic and its foundation donate $3.8M more to COVID relief

December 1, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Funding Roundup Tagged With: coronavirus, COVID-19, Medtronic, The Medtronic Foundation

Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook

December 1, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, MassDevice Earnings Roundup, Replacement Heart Valves, Research & Development, Structural Heart, Wall Street Beat Tagged With: Boston Scientific, coronavirus, COVID-19, tavr

FDA allows dry heat treatment for single-user mask reuse

November 30, 2020 By Nancy Crotti

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, […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Lab Instruments & Supplies, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, National Institute for Occupational Safety and Health, U.S. Centers for Disease Control and Prevention

BREAKING: Moderna is filing for a COVID-19 vaccine EUA

November 30, 2020 By Chris Newmarker

Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Moderna

MedTech 100 roundup: Medtech stocks stagnant over holidays

November 30, 2020 By Sean Whooley

Following the medtech industry’s rapid rise early in the month, a plateau was inevitable, and that trend continued through the holiday week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.23 (Nov. 27), marking a 0.2% uptick from the 97.99 points registered at the […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: 3m, AstraZeneca plc, Boston Scientific, butterflynetwork, coronavirus, COVID-19, MedTech 100 Index, Medtronic

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