The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3X4 Genetics, Access Genetics, Autonomix, Bioinformatics Solutions, Capsulomics, Danaher, Digital Health Navigation, Echolight, Envoy, Gradient Denervation Technologies, Healthlynked, Lin Health, LISA, Mayo Clinic, Mpath Health, Neuraxis, Novastep, Osteotec, Oraldna Labs, Previse Dx, Sciex, Sensible Diagnostics, Twist.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eptiel, Irhythm, Peytant.
The U.K. National Institute for Health and Care Excellence endorsed the Qb Test by Qbtech AB of Stockholm to aid in diagnosis of attention deficit/hyperactivity disorder in those aged 6 to 17.
Starting with a study of how mutations affect sensitivity to 10 molecularly targeted drugs, researchers have laid the foundations for a prospective, systematic approach to understanding the genetic mechanisms behind cancer drug resistance.
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
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