The digital therapeutics market has surged during the pandemic and looks likely to markedly change health care long after the current crisis abates. The need for distance, limited in-person appointments, increased stress and mental health issues, and a more relaxed U.S. FDA approach have created the ideal environment for the rollout of therapies patients can use from home on their own time. Increasingly, clinical trials demonstrate the effectiveness of the new options and users praise the convenience.
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DOJ arraigns test maker for investor fraud.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beroni Group, Canon Medical, Scone Medical Solutions.
Keeping you up to date on recent developments in cardiology, including: Biomarkers can forecast the development of incident heart failure; Mouse model helps researchers find MAARS lncRNA; Heart disease deaths rise in age of COVID-19.
PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cerenion, Ecolab, Integrum, Occlutech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Littmann Stethoscopes, Assure Tech, Aurora Spine, Bc Platforms, Beckman Coulter, Biosig Technologies, Bruker, Cerus Endovascular, Emurmur, Fulgent Genetics, Htg Molecular Diagnostics, Ingenion Medical, Inivata, Johnson & Johnson, Medsential, Misonix, Natera, Oncimmune, Paxman Coolers, Physiomics, Pra Health Sciences, Pwnhealth, Research Instruments, Roche, Tabula Rasa Healthcare.
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