New gut devices get an easier path to US market approval

US health regulators just made it easier for a new type of device to reach patients. These devices, which are swallowed and pass through the body to treat constipation, will now face fewer regulatory hurdles than the highest-risk medical products.

US health regulators sort medical devices into three risk classes. The highest class requires extensive clinical trials, which are expensive and slow. This rule puts a new category of swallowed devices into the middle class. This means companies can bring these specific products to market faster and cheaper.