Dive Brief:
- The Food and Drug Administration has told Soulaire to stop commercial distribution of its device intended to treat angina, or chest pain and discomfort, outside of authorized indications.
- FDA officials published the demands in a warning letter Tuesday. In the letter, which the agency sent in January, the FDA accused Soulaire of promoting an external counterpulsation device that acts on blood flow in unauthorized indications including stroke, diabetes and long COVID-19 symptoms.
- The agency said it may take further actions if Soulaire fails to stop activities that result in the misbranding or adulteration of the device.
Dive Insight:
Soulaire received 510(k) clearance for the device in 2020. Like other external counterpulsation devices, the product features cuffs that inflate and deflate in sync with the patient’s cardiac cycle. Fitted to the patient’s calves and thighs, the cuffs cause a counterpulsation wave that alters blood pressure and other cardiovascular variables.
The FDA cleared the device in chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, as well as in healthy people who want to improve the dilation of their blood vessels and increase blood flow.
FDA officials found Soulaire discussed other applications on its website. The warning letter notes uses including the growth of new arteries, reduction or elimination of blood pressure medicine, regeneration of pancreatic tissue and hair growth. The FDA saw statements about those applications and other uses of the device when it visited Soulaire’s website in December 2023.
Because the uses differ significantly from the cleared indications, the FDA said the website presented major changes or modifications to the device’s intended use. The FDA also said the website offered the device for sale to a business, home or sports team. Soulaire’s device is cleared for use under an order of a physician or the oversight of a healthcare professional, but the FDA said the website suggests it could be sold without the order of a physician.
The FDA asked Soulaire to stop the commercial distribution of the device for the unauthorized uses and otherwise cease activities that result in the misbranding or adulteration of the product. Failure to take prompt action could trigger regulatory actions such as seizure, injunction and civil money penalties, the agency said.
FDA officials have made similar statements in multiple warning letters over the past decade, telling medtech companies including Iradimed, Opternative, Invisi Smart Technologies and Agena Bioscience to cease activities that result in misbranding or adulteration.