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.

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.

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.

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.

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.