Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Curiteva, Theranica Bio-Electronics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anteris, Gedi Cube, Hyperfine, Myriad Genetics, Renovaro, T2 Biosystems.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent Technologies, Corstrata, Dariohealth, Element Biosciences, Fesarius Therapeutics, Health Recovery Solutions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pentax Medical, Qiagen.
Three former employees of Bose Corp. are banking on their audio experience and Ozlo Sleepbuds helping the millions of people who struggle to sleep soundly each night. That prospect is music to the ears of investors Lifearc Ventures and Artis Ventures, who led Ozlo Sleep Inc.’s $10 million round to bring the wireless, in-ear headphones to market in the next few weeks.
The debate in the U.S. over the process by which the Medicare program covers new medical technologies has intensified over the past three years and the debate has now spilled onto the pages of the Journal of the American Medical Association. An article in JAMA asserts that only 44% of a group of 64 novel devices had achieved meaningful coverage and reimbursement milestones within a median of 5.7 years after FDA market authorization, adding yet more pressure on the legislative and executive branches to act to deal with what device makers characterize as the med-tech valley of death.
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