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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dialco, Masimo.
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.
Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery. “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B. Braun Medical, Cureapp, Foundation Medicine, Healeon, Med-El, Sanuwave Health.