Many venture-backed digital health startups aren’t clinically robust, as measured by the number of regulatory filings and clinical trials, according to a study published in JMIR.
The analysis examined digital health companies using the Rock Health Digital Health Venture Funding Database, FDA data on 510(k), De Novo and premarket approval filings, and the number and type of clinical trials listed on ClinicalTrials.gov. Researchers then assigned a “clinical robustness” score for each company, the sum of the number of regulatory filings and clinical trials weighted equally, Mobi Health News reports.
Of the 224 startups included in the study, 98 had a clinical robustness score of 0, while 45 received a five or higher. The average score was 2.5, with 1.8 clinical trials and 0.8 regulatory filings, and the median score was one.
Companies that aimed to diagnose conditions had the highest average score at 2.8, then treatment-focused companies, at 2.2, and finally prevention startups, with a score of 1.9. Read more.
