fda-cleared-device
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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.
Cody Simmons
Cody Simmons is the co-founder and CEO of DermaSensor, a Miami-based medical device company behind the first FDA-cleared, AI-powered handheld tool that helps primary care physicians evaluate skin lesions for cancer in seconds using elastic scattering spectroscopy. A bioengineer with a Brown degree, a Stanford master's and four years at Genentech, he took over the company in 2016 and spent nearly a decade shrinking a microwave-sized prototype into a point-and-click device, navigating FDA breakthrough designation, a De Novo clearance in early 2024, and a $16M Series B in 2025.