Physician-owned distributorships (PODs) were the subject of concern by medical device makers and members of Congress as long as a decade ago, and recent events would seem to justify some of those fears. The U.S. Department of Justice (DOJ) announced July 1 that two owners of a POD have agreed to pay $1 million to settle claims that they paid kickbacks to other doctors to use medical devices supplied by the POD, the very kind of violation of the Anti-Kickback Statute that undergirded some of the earlier concerns about these business arrangements.
Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with its regenerative nerve repair device Remplir.
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the Court has declined to hear the American Axle case, which some see as presenting an exceptionally low bar for subject matter eligibility, leaving many observers despairing of any chance of restoring a decent patent system for makers of in vitro diagnostics and other items that are among the mainstays of the medical device industry.
Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.
Israeli startup Synchrony Medical Ltd. is gearing up to begin a U.S. clinical trial testing an airway clearance method developed at Israel’s Sheba Medical Center. The Libairty device is designed to support chronic lung disease patients to clear mucus with a short home-based daily treatment.
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ra Medical, Siemens Healthineers.
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