NeuroMetrix Gets FDA De Novo Authorization For Neuromodulation Device To Treat Fibromyalgia
NeuroMetrix plans to market the prescription-based Quell in the fourth quarter to US rheumatologists and pain medicine physicians.
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In this month’s Digital Health roundup, Medtech Insight’s Marion Webb discusses her deep-dive article on menopause with leading experts in this rising industry and Barnaby Pickering highlights UK-based Proximie, which developed a web-based platform that allows surgeons and other clinical experts to collaborate virtually in the operating suite. The company recently raised $80m in a series C round.
OTC Device Claims Regulation: FTC Targets Quell On Pain Relief, FDA Warns Zona Plus On BP
An FTC member doubts NeuroMetrix crossed all FDA regulatory lines in advertising for Quell wearable pain relief technology that attorneys alleged. FDA warning letter says Zona Health executives said they “would ‘remain in all regulatory guidelines’" when the agency in 2018 explained claims violations.
Getting Personal With Brittany Barreto: From One-Time ‘Science Hater’ To Genetics Doctorate, DNA Dating App And Women’s Health Champion
Medtech Insight sat down with Brittany Barreto, CEO of FemHealth Insights, who participated in a panel discussion at SXSW 2023 on the $1t femtech industry, to talk about her journey to becoming a women’s health care champion.