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# Follea De Novo for Minoxidil Response Test
- URL: https://www.fdaweb.com/follea-de-novo-for-minoxidil-response-test/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139979

Follea International has submitted to FDA a de novo application for its Minoxidil Response Test, a prescription device to be used by a doctor as an aid in assessing the likelihood that a patient is suffering from pattern hair loss and will not respond to topical minoxidil therapy. The company [says](http://www.marketwatch.com/story/follea-submits-to-the-us-fda-a-de-novo-application-for-the-minoxidil-response-test-2017-10-26?ref=fdaweb.com) that while Minoxidil’s safety has been established, its efficacy remains relatively low, with only 30% to 40% of patients responding following four to six months of treatment. It says the response test helps identify the 60% to 70% of patients who will not respond to the treatment. “Since hair loss is progressive,” Follea says, “it would be of great clinical utility if non-responders could be identified early and prescribed alternative treatment.”