Selux Diagnostics Inc. raised $50 million in a series C financing to support the commercial launch of its next-generation phenotyping (NGP) rapid antimicrobial susceptibility testing platform. RA Capital Management LLC led the round with participation from Sands Capital, Schooner Capital and Northpond Ventures, all returning investors. Read More
Chinese company Seekin Inc. is preparing to launch its cancer detection technology in Europe after securing CE marking for the Seekincare pan-cancer test. The artificial intelligence, blood-based platform uses insights from public and private data to identify cancer DNA and protein signals in the blood. The test has been available in Chinese labs since 2018. Read More
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade. Read More
Even as China sees strong and continuous growth in patent applications from its medical technology industry, regulators are imposing stricter regulations to curb what they see as "abnormal applications." China’s medical technology sector saw year-on-year growth of 28.7% in 2021 for valid invention patents, according to data from the China National Intellectual Property Administration. Read More
There are several devices on the market to repair the dreaded abdominal aortic aneurysm (AAA), but these carry some serious risks that have prompted multiple FDA advisories. The agency’s latest announcement recommends routine clinical follow-up for these patients for life, and the formation of a “real-world surveillance system” that may require the financial and technical assistance of industry and medical societies to develop. Read More
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Freenome, Genialis, Inhibrx, Inspiremd, Intricon, Invera Medical, Photocure, Qiagen, Ra Medical, Singular Genomics, Tria Transcatheter, Venari Medical.
