Mitral Valve Pioneer: An Interview With Evalve’s Ferolyn Powell And Fred St. Goar
Transcatheter aortic valve replacement is all the rage today, but potentially larger is the mitral valve market, a market that can also be bewilderingly complex. The story of mitral valve pioneer Evalve illustrates both the challenges and promise of mitral valve repair and replacement.
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Yes To is investigating reports – including posts on leading social media platforms – regarding irritation and redness experienced by children and other users of its Yes To Grapefruit Glow-Boosting Unicorn Paper Mask. In the meantime, the company is recalling the product voluntarily.
A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.
Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 6)
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.