Dive Brief
The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions.

Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age.

The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval.

Dive Insight
In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and cognitive function,” the FDA wrote.

Wavi told the FDA that the product is for research use only. However, according to the warning letter, the company failed to provide evidence of an approved application for an investigational device exemption (IDE). Responding to the agency’s inspection form, Wavi said the studies to build Wavi Scan were IDE exempt and that Wavi Desktop is not subject to IDE requirements. The FDA said the letter lacked supporting evidence.

Officials quoted Wavi’s website to rebut the claim that the device is only used in research settings. The warning letter quotes a line about how the device provides “doctors, researchers and wellness experts with actionable, data-driven reports,” as well as the testimonies of multiple physicians. Wavi’s website also previously allowed users to search for practitioners such as a “brain spa” that made clinical use of the device, according to the warning letter.

The second half of the warning letter covers alleged violations of quality system regulations. According to the FDA, Wavi distributed devices with non-validated Wavi Desktop research software.

Wavi told the FDA “there is no requirement for research software to be validated.” The FDA disagreed, citing the quality system regulation.

The FDA sent the warning letter on Oct. 20 and gave Wavi 15 business days from the date they received the letter to respond. Failure to fix the violations could lead to regulatory actions including “seizure, injunction and civil money penalties.”

Source:
https://www.medtechdive.com/news/fda-warning-letter-wavi-neurological-headset/698414/