FDA Finishes Review of Guided Therapeutics’ LuViva PMA Request
The FDA has completed reviewing Guided Therapeutics’ LuViva advanced cervical scan premarket approval application, saying it would not approve the devicemaker’s July 2014 amendment. The agency indicated it would most likely need more patient data before signing off.
The company said Tuesday it intends to meet with the FDA where it will present additional data, as well as finalize plans for a resubmission with an updated amendment.
Guided’s first product, LuViva is a noninvasive device that uses spectroscopy to measure light interaction with tissue, a method of identifying chemical and structural indicators of cervical cancer. In contrast to Pap or HPV tests or biopsies, the device doesn’t require laboratory analysis or tissue samples and delivers results instantaneously, the company says.
LuViva is available in Europe, and has received approval from Mexican, Canadian and Singaporean regulators. — Jason Scott