Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908, Akili, Bostongene, Genomics, GSK, Laborie, Lunit, Liberate, Radiobotics, Redwave Technology, Seastar Medical, Shionogi.
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeye Health, Senseonics, Route 92 Medical, Single Pass, Toku.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Labs, Clearpoint Neuro, Labcorp, Leica Biosytems, Sectra.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Bio-Techne, C2N Diagnostics, Donaldson, Hermes Medical, Ivantis, Medica, Mediford, Ossdsign, Spectrum Dynamics, Thermo Fisher.
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