The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
The U.S. CMS has unveiled a proposed national coverage determination for powered seat elevation systems for Group 3 power wheelchairs, one of the more expensive items in the category of mobility durable medical equipment (DME). However, the agency indicated that it will soon examine coverage of powered seat elevation systems for Group 2 power wheelchairs, the combination of which suggests that manufacturers in the DME space are looking at a market that seems poised to explode.
A cancer therapy test unveiled by Exact Sciences Corp. will be able to provide a complete molecular picture of a patient’s tumor allowing for them to receive the most effective treatment as quickly as possible. Exact’s Oncoextra therapy selection test, recently launched in the U.S., enhances the ability of doctors to characterize and understand solid tumors.
Xeltis BV has completed a €32 million (US$34 million) series D2 round that will propel the clinical development of its electrospun polymer implants across several indications. The fully synthetic implants promise the best of both worlds, with the mechanical strength required to be fully functional from day one, and bioresorbable properties that cause gradual degradation as endogenous tissue regenerates to form a natural replacement.
Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Innovation Zed, Medasense Biometrics, Mologic, Remidio.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brain Scientific, Delve, Diabeloop, Glooko, Grail, Rafa Laboratories, Relievant, Sanofi, Sonex Health, Terumo.
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