New Delhi, Mar 14 (PTI) Healthcare firm Niramai Health Analytix on Monday said it has received approval from the US health regulator for its device SMILE-100 System.
The product is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region.
It can be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.
It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region.
“It was a great learning experience to go through the very rigorous US regulatory process. This win further validates the intrinsic power of the NIRAMAI team and has given us the confidence that we can build many more such world-class medical devices of high quality and help reduce untimely deaths due to cancer,” Niramai Founder and CEO Geetha Manjunath said in a statement.
The US Food and Drug Administration (USFDA) approval will now give the company a tool to foray into the US market and beyond, it added.
The Bengaluru-based Niramai is a pioneer in breast cancer screening with 26 granted international patents.
Last year, the company had announced European CE approval for its Thermalytix Solution and it has already started pilots in multiple European countries. PTI MSS MSS AJ ABM ABM
