Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Globus Medical, Hyperfine, Subtle Medical.
The €10.2 million (US$11 million) that Bedal International NV recently closed in a funding round is “crucial” for the company’s continued growth and development, co-CEO Alexander Van Damme, told BioWorld. “The financing provides the necessary resources to scale up operations, enhance product development, and expand market reach, particularly in the competitive U.S. market,” he said.
The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
The first patenting from Los Angeles-based Ecate LLC sees the company’s founder, Allesandro Maggi, describe a bi-directional, closed-loop spinal cord machine interface that can bridge the gap in communication between the brain and the body in paralyzed patients.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Discgenics, IR-Med, Masimo, Microvention, Nurami, Vectorious.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Positrigo, Smith+Nephew.
The word “niche” implies a specialized environment. But to Fiona Doetsch, the stem cell niche is anything but. For brain stem cells, “the whole organism is the niche,” Doetsch told the audience at the third plenary session of the International Society for Stem Cell Research (ISSCR) annual meeting in Hamburg this week.
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