Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icometrix, Theranica.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ATSS, Arsenal Medical, Azenta, Bluejay, Centinel, Corvista, Diagnamed, IMAC, J&J, Pacbio, Responsive Arthroscopy, Vergent Bioscience.
At the BioFuture 2024 conference held in New York in November, Seema Kumar, the CEO of Cure, described women’s health as something that has been directed at the “bikini area.” That “bikini” bias extended to both diseases and their causes – women’s health covered the breasts and reproductive system, and its causes were hormonal. Both concepts are far too narrow.
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. There are many conditions that disproportionately impact women. Other conditions and diseases affect women in different ways than men. Decades of research excluding women from clinical trials and investment decisions in male-dominated board rooms have ignored these facts. Though an increasing number of women are now managing investments and driving the research, it’s all still woefully behind. In BioWorld’s new report, Healing the health divide, we’ve highlighted the disparities.
Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
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