LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Accuray, Biocrucible, CM Life Sciences, Daxor, Concordance Healthcare Solutions, Dermtech, Gemspring Capital Management, Grail, Graphenedx, Illumina, Invivoscribe, Koko, Kkr, Longuevue Capital, Lucid Diagnostics, Medical Microinstruments, Nanalysis, One Moon Scientific, Pacemate, Pavmed, RBC Medical Innovations, Relay Medical, Sema4, Starfish Medical, Transcenta, Twist Bioscience, Upscripthealth, Visualdx, Zavation Medical Products.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, Agilent Technologies, Clx Health, Guided Therapeutics, Health Decisions, Micronoma, Novocardia, Ortho Regenerative Technologies, Pacific Biosciences, Premier Research, Quest Diagnostics, San Omniome, Shandong Yaohua Medical Instrument, Terumo Europe, Theator, Thomas Scientific, Xphyto Therapeutics.
Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Foundation Medicine, NG Biotech.
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