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Influencers Are Claiming a $4,000 Hunk of Plastic Can Treat Infertility, Skinned Knees, and Autism

The device comes in various “editions,” which range from $500 to more than $4,000 for the “professional” version. It pairs with a smartphone and clips onto clothes, and comes with various ... read more

High risk devices can be exempted from mandatory trials under EU MDR

Although clinical investigation is not mandatory in this case, a post-market clinical follow-up (PMCF) study is required to demonstrate the safety and performance of the device, said Thomas. read more

Mainstay Medical Announces Publication of Clinical Results Comparing Older Patients and Younger Patients

The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor ... read more