FDA warns consumers not to use unapproved ultrasound devices
The U.S. Food and Drug Administration on Monday warned consumers not to use ultrasound devices from a troubled Texas-based device manufacturer and distributor.
RoyalVibe Health—also doing business as CellQuicken, Well-Being Reality, and potentially other names—offers direct-to-consumer focused-ultrasound scanners purported for multiple medical uses. Those include diagnosing, treating and curing conditions including cancer, diabetes, heart disease, Parkinson’s and depression.
However, the devices have not been reviewed by the FDA, nor have they received 510(k) clearance or premarket approval.
“Using these medical devices may result in adverse effects, including pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness,” the agency announced July 17. “The FDA is concerned that consumers may be using these medical devices instead of seeking care from a healthcare professional.”
Regulators expressed initial concerns about the company in a November warning letter to RoyalVibe Health CEO Raymond L. Venter. During an attempted inspection of its facilities in Woodlands, Texas, last year, an investigator determined that the company had been marketing its RoyalVibe Ultrasound Generator, along with several other devices, without the proper approvals.
The FDA is urging consumers to avoid using the ultrasound devices and to speak with a provider about any health concerns. Physicians, meanwhile, should advise consumers not to use the ultrasound devices and also review these FDA recommendations.
RoyalVibe carries an F rating and is not accredited by the Better Business Bureau. A call to the phone number listed on its BBB page went to a receptionist at Well-Being Reality, which could not immediately provide comment on the FDA alert issued Monday. Those who experience problems are urged to submit a report via the agency’s MedWatch Voluntary Reporting Form.
“Prompt reporting can help the FDA identify and better understand the risks associated with the medical devices and improve patient safety,” the agency said.
The company reportedly refused an FDA inspection earlier this year and has continued to sell its products since the warning letter, MedTech Insight reported. As of Monday, RoyalVibHealth.com was not working, but CellQuicken.com and Well-BeingReality.com remained operational, marketing the same products in question. Another website using the name Heal Navigator also carried CEO Raymond Venter’s name and continued to offer the ultrasound product and other devices as of July 17.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.