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.
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.
COVID-test maker Cue Health said it laid off 170 people in its manufacturing facility but remains “confident in its long-term strategy.”