Some of the most exciting news out of the European Society for Medical Oncology Congress 2022 in Paris surrounded the rapidly evolving field of multi-cancer early detection (MCED), which offers the dual benefits of identifying malignancies at a more easily treated local stage and enabling screening for the 70% of cancers that lack recommended screening tests. Read More
Nutromics Pty Ltd. has raised $14 million to build out its wearable diagnostic platform that uses DNA sensors to track multiple targets in the body using a single patch. Read More
U.S. FDA commissioner Robert Califf resurrected a litany of complaints about medical product misinformation, including vaccinations for the COVID-19 pandemic, in a televised presentation heard by attendees at the Regulatory Affairs Professional Society (RAPS) annual conference here in Phoenix, where the daytime high temperatures are hovering at or near the century mark. Read More
The casual observer may be inclined to think that the European Union’s Medical Device Regulation (MDR) is off to a rocky start, but those whose livelihoods are at stake have a more intimate view of the situation. An attendee at a Sept. 12 session at this year’s Regulatory Convergence lamented what she believes is a dismal outlook for EU patients and device makers in the coming year, a testimonial that drew cheers and applause from those in attendance. Read More
With a goal of manufacturing biotechnology in the U.S. that’s invented in the U.S., President Joe Biden signed an executive order Sept. 12 launching a National Biotechnology and Biomanufacturing Initiative that’s intended to strengthen the country’s bioeconomy, build stronger supply chains, and better utilize and secure biological data. Read More
Guardant Health Inc. expanded its cancer testing to include one that provides multi-dimensional insights into tumor profiles and microenvironment that can be used to guide therapy selection. The liquid biopsy, Guardantinfinity, combines analysis of more than 800 genes with exome-wide methylation detection. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Exact Sciences, Oncxerna, Pulmonx, Reveal Genomics, Seqll. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aldatu, Brain Navi, Catheter Precision, Dnanexus, Foundation Medicine, Heska, Lightdeck, Mbio, Medtreq, Ontogen, Ra Medical, Relay Therapeutics, Synergy Spine. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Curvebeam AI, Haemonetics, Magbio. Read More
