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 led the round with participation from Sands Capital, Schooner Capital and Northpond Ventures. Selux NGP returns results in five to 24 hours, allowing clinicians to treat infections with the most appropriate antimicrobial agent and preserving the efficacy of critical antibiotics.
Europe gives green light to Seekin pan-cancer early detection test
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.
US FDA says first-cycle PMA major deficiency rates spiked in 2021
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 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.
Chinese companies embrace stricter patent regulations
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 (CNIPA). “The continuous growth of patent reserves in core technology areas will strongly support industrial upgrading and better benefit the lives of the people,” said Hu Wenhui, deputy director and spokesperson of the CNIPA.
US FDA eyes real-world surveillance for devices indicated for repair of AAAs
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 U.S. 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.
Also in the news
Blue Earth Diagnostics, Biotronik, Cvaid, Envveno Medical, Foldax, Freenome, Inspiremd, Intricon, Masimo, Philips, Photocure, Qiagen, Ra Medical, Sharps Compliance, Singular Genomics, Standard Bariatrics, Venari Medical, Veracyte