Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mim Software, Novarad.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arome Science, Bebig Medical, Brainsway, Nusano, Pharmalogic, Raysearch, Thorne Healthtech.
Ravgen Inc.’s patent litigation strategy could add another $100 million to the company’s coffers, assuming enhanced damages in its suit against Laboratory Corp. of American Holdings (Labcorp) awarded on May 12 are sustained on appeal. The additional damages are on top of the $272.5 million awarded in September for “egregious” violations of Ravgen’s patents on non-invasive prenatal testing methods.
The U.S. Securities and Exchange Commission (SEC) reported that Royal Philips NV will pay more than $62 million in connection with “irregularities in the medical device industry” related to its Chinese subsidiaries. The charges arise from actions that occurred between 2014 and 2019 from sales of medical diagnostic equipment in China.
Quantum Surgical SAS has obtained an extension to the FDA authorization covering its Epione robot, which can now treat abdominal cancers. “This decision now allows physicians to treat all abdominal tumors at an early stage and will ramp implementation of our Epione robotics solution in the U.S.,” said Bertin Nahum, CEO and co-founder of Quantum Surgical. Marketed in Europe and the U.S., the Epione robot has already been used to treat more than 150 patients with liver or kidney cancer.
Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director.
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