fda-cleared-device
(2)
Materna Medical
Materna Medical is a Mountain View, California women's health company building FDA-cleared medical devices for pelvic health across a woman's life. Its consumer product, Milli, is the first vaginal dilator that expands one millimeter at a time to treat vaginismus and painful intercourse; its clinical-stage Ellora obstetrical system is designed to pre-stretch pelvic floor muscles during labor to reduce childbirth injury. Led by CEO Tracy MacNeal, the company has raised roughly $82.6M to date.
DermaSensor, Inc.
DermaSensor is a Miami-based medical device company that makes the first FDA-cleared, AI-powered handheld device for detecting all three common skin cancers - melanoma, basal cell carcinoma, and squamous cell carcinoma - at the point of care. Using elastic scattering spectroscopy and a machine learning algorithm trained on thousands of biopsy-confirmed lesions, the device gives primary care physicians a real-time, non-invasive read on whether a suspicious skin lesion warrants further evaluation, helping close the gap created by a shortage of dermatologists.