LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofourmis, Cepheid, Fluxergy, Nanovibronix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptargroup, BD, Bioventus, Boston Scientific, Consensus Business Group, Draper, EC Healthcare, Graymatters Health, Immunai, Medimaps Group, Medx Xelerator, Medx Ventures Group, Misonix, Nanalysis Scientific, Nebion, One Moon Scientific, Prenetics, Weihai Hengyu Medical Products.
PARIS – French sovereign bank Bpifrance SA, the Digital Health Agency (ANS) and Impact Healthcare SAS have just published results from the first survey on progress being made by digital health startups in France. The survey, with financial support from Astrazeneca plc from the U.K. and French law firm Delsol Avocats Selarl, was carried out among roughly 100 founders of digital health startups in France. It reveals a lot of information relating to the progress made by digital health projects 18 months following the outbreak of the COVID-19 pandemic. “It is a matter of recognizing there are barriers to the French market even though e-health products and services are booming following the COVID-19 crisis,” Jean-Yves Robin, managing director of Impact Healthcare and co-author of the study, told BioWorld.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, 903 Devices, 10x Genomics, Amwell, Angelmed, Armor Bionics, Bio-Rad, Blockmd, Carlsmed, Converse Health, Edgility, Exthera Medical, Fresenius Medical Care, Informed Data Systems, Levitee, NAMSA, NTT Research, Olympus, One Drop, Paragon, PCORI, Pear Therapeutics, Shapeways, Silvercloud Health, Still Technologies, Withings, Xphyto.
Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alere, Beckman Coulter, Eyenuk, Gamidor Diagnostics, Pixcell Medical, Quidel, Speedx, Sqi Diagnostics.
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
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