Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future.
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.
New hires and promotions in the med-tech industry, including: Bio-Techne, Carestream, Highridge Medical, Livanova, Marlabs, Meddux Development, Pixelgen, Sphere Fluidics.
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.