Tag: FDA

FDA Cautions Consumers Against Use of RoyalVibe Ultrasound Devices

The U.S. Food and Drug Administration issued a warning to consumers on July 17 about avoiding the use of ultrasound devices from a Texas-based manufacturer and distributor called RoyalVibe Health.

The company sells direct-to-consumer ultrasound scanners, marketing them to be used for various medical purposes, including diagnosing and treating serious conditions like cancer, diabetes, heart disease, Parkinson’s, and depression. However, the FDA has not reviewed these devices, and they lack the necessary 510(k) clearance or premarket approval.

 

What is 510(k) Clearance?

The 510(k) clearance is a regulatory pathway used by the U.S. FDA to evaluate and approve medical devices. If a new medical device is deemed substantially equivalent to a legally marketed device (known as a “predicate device”), the manufacturer can submit a 510(k) premarket notification to the FDA. The FDA reviews the submission to ensure the new device shares the same intended use and technology as the predicate device. If approved, the new device receives 510(k) clearance, allowing it to be marketed in the U.S. The 510(k) process is commonly used for moderate-risk medical devices and relies on the safety record of similar, already-approved devices to expedite approvals while ensuring safety and effectiveness.

 

Ultrasound Therapy

Ultrasound therapy is a non-invasive medical treatment that utilizes high-frequency sound waves to target specific tissues in the body. During the procedure, a handheld device emits these sound waves, which penetrate the skin and cause vibrations at a cellular level. This treatment process is believed to increase blood flow, relax muscles, and promote tissue healing. Ultrasound therapy is commonly used by physical therapists to alleviate pain, reduce inflammation, and improve tissue mobility in conditions like muscle strains, joint injuries, and certain musculoskeletal disorders. It is a safe and effective treatment that can provide relief and aid in the recovery process for various injuries and conditions.

 

Open Communication with Patients

Unfortunately, some consumers find products on the market that they can purchase directly in hopes to use for at-home self-care. Please advise your patients to be wary of these types of devices, including the products the FDA has not approved such as RoyalVibe Health. Patient education can go a very long way, so it is important to address their questions about their health, pain and concerns and emphasize that treatment should be administered by their healthcare provider.

 

Sources:

Fda.gov
 verywellhealth.com
 radiologybusiness.com
 openai.com

 

A device recently approved by the U.S. FDA made extremely precise images of a postmortem sample

A 100-hour MRI scan captured the most detailed look yet at a whole human brain

https://www.sciencenews.org/article/mri-scan-most-detailed-look-yet-whole-human-brain

A device recently approved by the U.S. FDA made extremely precise images of a postmortem sample .
BY

Over 100 hours of scanning has yielded a 3-D picture of the whole human brain that’s more detailed than ever before. The new view, enabled by a powerful MRI, has the resolution potentially to spot objects that are smaller than 0.1 millimeters wide.

“We haven’t seen an entire brain like this,” says electrical engineer Priti Balchandani of the Icahn School of Medicine at Mount Sinai in New York City, who was not involved in the study. “It’s definitely unprecedented.”

The scan shows brain structures such as the amygdala in vivid detail, a picture that might lead to a deeper understanding of how subtle changes in anatomy could relate to disorders such as post-traumatic stress disorder.

To get this new look, researchers at Massachusetts General Hospital in Boston and elsewhere studied a brain from a 58-year-old woman who died of viral pneumonia. Her donated brain, presumed to be healthy, was preserved and stored for nearly three years.

Before the scan began, researchers built a custom spheroid case of urethane that held the brain still and allowed interfering air bubbles to escape. Sturdily encased, the brain then went into a powerful MRI machine called a 7 Tesla, or 7T, and stayed there for almost five days of scanning.

The strength of the 7T, the length of the scanning time and the fact that the brain was perfectly still led to the high-resolution images, which are described May 31 at bioRxiv.org. Associated videos of the brain, as well as the underlying dataset, are publicly available.

Researchers can’t get the same kind of resolution on brains of living people. For starters, people couldn’t tolerate a 100-hour scan. And even tiny movements, such as those that come from breathing and blood flow, would blur the images.

But pushing the technology further in postmortem samples “gives us an idea of what’s possible,” Balchandani says. The U.S. Food and Drug Administration approved the first 7T scanner for clinical imaging in 2017, and large medical centers are increasingly using them to diagnose and study illnesses.

These detailed brain images could hold clues for researchers trying to pinpoint hard-to-see brain abnormalities involved in disorders such as comas and psychiatric conditions such as depression. The images “have the potential to advance understanding of human brain anatomy in health and disease,” the authors write.