DUBLIN – Abivax SA has rejected an acquisition offer in order to pursue a phase IIb/III trial of its lead anti-inflammatory drug ABX-464 in 1,034 COVID-19 patients.
Ventilators are not designed to sit in storage for long periods of time unused. But that’s precisely what’s often required of this medical device, which then may require substantial repair and updates before it is functional. That’s a tale that’s been told repeatedly in this pandemic.
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
How is the COVID-19 pandemic affecting cancer treatment plans? Oncologists are weighing switching treatment plans, and they have many questions. That’s where Nanthealth Inc., of El Segundo, Calif., is looking to help.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
The U.S. does not have a universal health care system, which means that it fails to provide a consistent level of minimum care across its population. That means that basic and preventative care often falls through the cracks, even as the U.S. continues to excel at medical innovation and offer the most highly regarded health care in the world to those who can afford it.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Critical Alert, Eko, Novocure, Optina Diagnostics, Zai Lab.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Scientific, Apiject, Atrium Health, Butterfly Network, Canon Medical, Carmat, Centene, Change Healthcare, Dermalog, DNA Electronics, The DNA Company, Drӓgerwerk, Edap Tms, Exact Imaging, Liva Healthcare, My Next Health, My Pain Sensei, Nuvo Group, Polyganics, Rapid USA, REMsleep Holdings, Smiths Medical, Surfacide, Thermo Fisher Scientific, United Healthcare Services, Wuxi Diagnostics, Xleratehealth.
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