Following days of speculation, Illumina Inc. said today it will acquire liquid biopsy startup Grail Inc. for $8 billion in cash and stock, bringing back into the fold a company it spun out in 2016. The deal gives Illumina a major stake in the race the race to develop a less-invasive way to diagnose cancer. Since spinning out, Grail has raised nearly $2 billion from big-name investors with promises of a blood test for early cancer detection and is hoping to introduce its liquid biopsy as a laboratory-developed test (LTD) as early as next year. Read More
Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020. Read More
The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case. Read More
The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19. Read More
TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue. Read More
Med-tech firms raising money in public or private financings, including: American Laboratory Products, Arna Genomics, Cit Group, Protech Home Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Medical Technology Association, Biocept, Boston Scientific, Dariohealth, Decision Diagnostics, Exagen, Gunze, Hancock Jaffe, Highmark, Hmc Healthworks, Icad, Mimedx, Misonix, Novartis, Ortho Clinical Diagnostics, Polarityte, Radiation Business Solutions, Radmax, Royal Philips, Siemens Healthineers, Startx, Titan Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics, Simplify Medical, Visby Medical. Read More
Keeping you up to date on recent developments in cardiology, including: Generating 3D heart organoids; Hostility and heart attacks; Virtual screening tool aims to simplify diagnosing pulmonary hypertension. Read More
