Claims That Cardiac Device Grows New Arteries Get Devicemaker FDA Warning Letter

Marketing its cardiac device — intended to treat chronic angina — for uncleared uses, such as growth of new arteries, reduction of COVID-19 symptoms, regeneration of pancreatic tissue and hair growth, has earned Soulaire, a Santa Monica, Calif., devicemaker, an FDA Warning Letter.

The FDA sent the letter to Soulaire for claims made on the company’s website about its External Counterpulsation (ECP) System Model: Soulaire, an external counterpulsating device intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.

The FDA found that the website made claims for which the company has no approved application for premarket approval or as an investigational device.

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