Promotional Communication. The medical devices SUDOSCAN is cleared by the US Food and Drug Administration (FDA). The test allows screening and monitoring of peripheral autonomic neuropathies. It can be performed in diabetic patients or in patients suffering from neurological diseases involving small fibers damage. As with any diagnostic test, its results must be interpreted in a global context including the clinic and other examinations performed. Please read the user manual instructions carefully. Contact our office for more information. Last update: 2021/01/12
Reimbursement & Regulatory
Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of SUDOSCAN.
SUDOSCAN is cleared by the US Food and Drug Administration (FDA). FDA Clearance
Impeto Medical Virtual Patent Marking:
The following Impeto Medical product(s) are protected by U.S. patents. The information provided within this website is to fulfill the virtual patent provisions of the America Invents Act, enacted on September 16, 2011. The following list of Impeto Medical product(s) may not be all-inclusive and may be protected by patents in other regions outside of the U.S.
- U.S. Patent No. 8,655,443
- U.S. Patent No. 8,918,170
- U.S. Patent No. 8,934,954
- U.S. Patent No. 9,211,080
- U.S. Patent No. 8,965,497
- U.S. Patent No. 14424,704 – Improved electrophysiological analysis system.
- U.S. Patent No. 9636036 – Electrophysiological analysis system.