Siemens (Munich, Germany) was warned by FDA that it must stop marketing an unapproved device used to evaluate the risk of heart disease.
The Syngo Arterial Health Package, promoted for use with several of the company’s ultrasound systems, lacks required approval, the FDA said in a letter posted yesterday on the agency’s website. Siemens was ordered to cease distribution of the device.
The company’s U.S. website claimed the Syngo device “empowers physicians and patients’’ to screen for early-stage hardening of the arteries, according to the FDA’s letter.
“Siemens is cooperating with the FDA in connection with this matter, and we hope to resolve the matter with the FDA in the near future,’’ Siemens said in a statement
Siemens’s ultrasound machines are approved in the U.S., although not for such uses, the FDA said. The Arterial Health Package is designed to screen for “vascular age,’’ indications that arteries are thickening with plaque, Siemens said.