In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: The International Contrast Ultrasound Society.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coghlin Companies, Cogmedix, Concord Medical, Dominion Aesthetics, Formsense, Genesis Medtech, Nowdiagnostics, Ontrak, Todos Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Can-Fite, Cormedix, Cstone, FDS, Gilead, Lipocine, Mustang, Omeros, Oncopeptides, Revive, Sound, Spero, Velosbio, Xortx.
Generex Biotechnology Corp.’s wholly owned subsidiary Nugenerex Health partnered with Worldwide Digitech (WWDT) LLC to create a 50/50 joint venture, Nugenhealth LLC. The new company will draw on WWDT’s software to develop an end-to-end software-as-a-service (SaaS) solution for chronic care management using remote patient monitoring.
Pooled testing was hailed early in the COVID-19 pandemic as a way to quickly and efficiently increase the number of people tested for the virus. But the approach has fallen short of its promise for a variety of reasons, from supply and labor shortages to high community infection rates. Now, a new testing method – recently approved for use by laboratories in Israel – could help chip away at some of those issues.
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