PERTH, Australia – In a boost for Australia’s medical technology innovators, A$3.2 million (US$2.4 million) in partnership projects are being deployed to help get innovative new medical devices to the next steps of starting human trials and early-stage manufacturing.
TORONTO – “There’s no magic pill that helps patients with concussion except physical activity,” Ashleigh Kennedy, CEO of Neurovine Inc. told BioWorld. But how does a patient in rehab know when to put on the brakes if they’re working too hard physically or mentally?
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Becton Dickinson, Bluestar Genomics, Inspire.
Keeping you up to date on recent developments in diagnostics, including: Blood-based test may help detect early Alzheimer’s disease; AI-based tool helps predict course of COVID-19; Myeloid cells differ in primary and recurrent glioblastoma.
As COVID-19 vaccinations continue to roll out, momentum builds with strong phase III data for what could become the fourth and fifth walls of defense in the U.S.
The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology.