Siemens Receives FDA Warning for Claims About Arterial Device

Siemens AG was warned by U.S. regulators 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 Food and Drug Administration said in a letter posted today on the agency’s Web site. Siemens was ordered to cease distribution of the device. The German engineering company’s U.S. Web site 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 an e-mailed response to questions. 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. SOURCE: Bloomberg