Device entrepreneur charged in $41 million fraud case

The Securities and Exchange Commission on Tuesday charged the former CEO of Stimwave, a company that sold devices containing dummy pieces of plastic, with allegedly defrauding investors out of $41 million. Laura Perryman led Stimwave, which sold nerve stimulation devices to combat pain, from 2010 to 2019, when the alleged fraud came to light. According to the SEC complaint, Perryman lied to investors between 2018 and 2019 by presenting the nerve stimulators with plastic components as FDA-approved — and that it was the "only effective device of its kind on the market."

STAT's Lizzy Lawrence reported extensive details about the Stimwave saga in May.

Personnel file

Verily CMO to depart

EMILIE PICKERING FOR STAT

In the latest of what seems to be a never-ending string of shake ups, Verily's chief medical officer Amy Abernethy will be leaving the Alphabet life science company at the end of the first quarter, STAT's Matthew Herper reported exclusively. Abernethy has been at the center of Verily's effort to modernize the way pharmaceutical and other companies collect data in clinical trials. She is leaving to launch a nonprofit aimed at changing how the health system collects data.

wearables

Apple data used to explore seasonal variation in menstrual cycles

In a new paper based on the Apple Women's Health Study, which uses the company's devices to collect data from volunteers, researchers looked at 125,104 menstrual cycles from 17,427 participants to see if they could suss out seasonal variability in the length of menstrual cycles. Ultimately, the researchers determine that across the population, the difference in lengths were modest — just a fraction of day — with the longest cycles observed in January through April and the shortest cycles occurring in September through December. The researchers also observed stronger seasonality among younger people and those with a history of polycystic ovary syndrome.

Regulation

CDRH releases real-world data draft guidance

The Food and Drug Administration's Center for Devices and Radiological Health has released a draft of updated guidance on the use of real-world evidence. The guidance aims to clarify how FDA will evaluate real-world data collected in electronic health records, by patients at home, by devices, and in other ways, to see whether it can be used to make regulatory decisions about devices. There is much to unpack, but for now, know that comments are open until February 20, 2024. We'll be watching for anything interesting — let us know your thoughts.

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