Illumina Inc.’s troubled takeover of Grail Inc. is facing further backlash from the European Commission (EC) after the regulator issued a statement of objections to the companies following their alleged breach of the EU Merger Regulation. Illumina’s acquisition of Grail has faced scrutiny from regulators since it was first announced due to concerns the deal could curb innovation and competition. Read More
Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan. Read More
The Medicare Coverage of Innovative Technology (MCIT) rule is administratively a dead letter, but the U.S. House of Representatives’ Cures 2.0 legislation would statutorily resurrect the MCIT concept. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said automatic coverage of breakthrough devices does not constitute a subversion of the Medicare coverage process, but added that AdvaMed is not opposed to other means of cutting the Medicare red tape, such as greater resources at CMS.
While the FDA has not provided transcriptions for device user fee meetings in roughly five months, the agency is still demonstrably determined to increase the volume of user fees. A source close to the negotiations told BioWorld that the latest proposal from the agency, dated Sept. 22, would require that industry come up with roughly $2.5 billion over the next five fiscal years, more than double the amount under MDUFA IV. Read More
Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications. The findings, along with others, could form the basis of an inhaled biologics treatment for COVID-19 and, ultimately, other respiratory diseases. Read More
TORONTO – Zilia Inc. has raised C$4 million (US$3.16 million) in seed financing to push new ocular diagnostic technology to regulatory finish lines in the U.S., Canada and eventually Europe. Zilia co-founder and CEO Patrick Sauvageau said the Zilia Ocular is alone in measuring oxygen saturation in the eye, an important biomarker for eye diseases such as glaucoma, diabetic retinopathy and age-related macular degeneration. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocartis, BK Medical, Digital Therapeutics Alliance, Draper, Evoendo, Gamma Biosciences, GE Healthcare, Neuroone, Orasure Technologies, Roche Diagnostics Canada, Second Genome, Squid Healthcare, Theromics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bionaut Labs, Moleculight, Zymo Research. Read More
