The U.S. FDA has issued a warning to consumers about the potential dangers associated with ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. These devices have not undergone FDA review, and their safety and effectiveness in diagnosing, treating, or curing medical conditions have not been established, according to the FDA. Moreover, using these unauthorized medical devices can lead to adverse effects such as pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness, agency officials add.
The FDA is particularly concerned that individuals may rely on these devices instead of seeking professional medical care. Delaying treatment for a medical condition can be life-threatening, allowing the disease to progress and increasing the risk of further sickness or injury.
To safeguard their health, consumers are strongly advised against purchasing or using ultrasound medical devices from RoyalVibe Health, CellQuicken, or Well-Being Reality. It is essential to be aware that these devices have not been proven safe or effective in diagnosing, treating, or curing medical conditions. If any concerns arise regarding their health, individuals should consult a healthcare provider promptly rather than relying on these unauthorized devices.
If anyone experiences adverse effects—such as include pain, bruising, burns, scarring, nerve damage, muscle weakness, or numbness—after using these medical devices, it is crucial to seek immediate medical attention. After all, the FDA says, focused ultrasound technology, when used without proper authorization and oversight, can pose serious risks to individuals’ well-being.
Healthcare providers are advised to inform their patients about the FDA’s warning and explicitly caution against using RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound devices. These devices have not undergone FDA review, and their safety or effectiveness in treating medical conditions, such as cancer, diabetes, heart disease, Parkinson’s disease, and depression, has not been demonstrated.
The FDA has taken action by issuing a warning letter to Raymond L. Venter, MD, the CEO of RoyalVibe Health, who is also involved with CellQuicken and Well-Being Reality. The letter highlights the violations, including the lack of FDA clearance or premarket approval for these ultrasound devices. Further, the FDA is working with the company to address these violations and will provide updates if significant new information emerges.
In the event of any problems or adverse events related to medical devices, individuals are encouraged to report them to the FDA through the MedWatch Voluntary Reporting Form. Timely reporting allows the FDA to identify and understand risks associated with these devices, ultimately improving patient safety, according to the FDA.