Latest Funding Round Takes EarlySense Deeper Into Digital
This article was originally published in The Gray Sheet
A $25m series G funding round for the mattress-based remote monitoring firm will help the company drive adoption of its contact-free continuous monitoring technology.
You may also be interested in...
“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”
Deal Snapshot: The Danish drug maker plans to pay up to $2.7bn to Flagship Pioneering-incubated Valo Health for its AI-enabled small molecule discovery and human genetic data platform.
Sponsor’s assertion of a ‘floor effect’ cannot explain the lack of difference versus placebo on clinical endpoints, and there is no evidence that assessed biomarkers are reasonably likely to predict clinical benefit, agency says. Although advisory committee will focus primarily on efficacy, FDA also cites concerns about ‘grossly deficient’ product quality information.