Niramai gets US FDA clearance for their first medical device, SMILE-100 System

US markets now open for the Innovative Indian Startup

Bengaluru, 14 March, 2022: Niramai Health Analytix, the deep-tech Bangalore-based healthcare company offering a novel radiation-free, non-touch, accurate, breast cancer screening solution in India, has now received US FDA clearance for their first device called SMILE-100 System. The SMILE-100 System is a breast thermography device that helps a healthcare personnel to review, measure and analyze 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.  

The SMILE-100 System assists experts to visualize high thermal activity patterns clearly demarcated on thermal images as hotspots and can enable healthcare professionals to make better decisions in breast cancer screening and diagnosis.  Another unique feature of SMILE-100 is use of their patented artificial intelligence-based algorithms to check the quality of input thermal images, which can greatly reduce the errors in thermal image capture and enable low skilled health workers to confidently perform the imaging. 

Dr. Geetha Manjunath, CEO and Founder of Niramai, said, “We are super excited to announce the FDA 510(k) clearance of SMILE-100 System. A proud moment for the team. It was a great learning experience to go through the very rigorous US regulatory process. This win further validates the intrinsic power of 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 is a pioneer in the breast cancer screening with 26 granted international patents. An US FDA approved device is a marquee asset for any Indian health-tech company. In fact, Niramai is the first Indian company to get an US FDA clearance for a medical device used for women health. Last year, the company announced European CE approval for their Thermalytix™ Solution and have already started pilots in multiple European countries. This FDA approval will now give Niramai a tool to foray into the US market and beyond.

Dr Kiran Mazumdar Shaw, the global biotech business leader and Biocon chairperson appreciated this news and said “I congratulate Geetha and her team for this tremendous achievement. Niramai is one of the very few deeptech startups from India which has obtained both European and US clearance for their innovative medical device. Indian startups are solving important healthcare problems that is the need of the hour today. Such milestones of innovation showcase the power of Indian women-led companies to the rest of the world”.

Mr. Manish Singhal, Founding Partner of pi Ventures and the lead investor of Niramai who has been part of their journey since 2017, commented, “In the last five years, we have seen Niramai grow in every aspect – product innovation, team strength, clinical provenance, product adoption and international recognition. I congratulate the team for this exciting win of the FDA clearance for their SMILE-100 System. It’s a great feat for any Indian Startup to get US approval for their medical device. This can be the key inflection point for the company to take their product truly global saving lives all the world.”

NIRAMAI has now created its own reputed brand in India with their innovative breast health products.  Partnering with experienced radiologists and reputed hospital / diagnostic chains in India such as Apollo Clinics, HCG Cancer Hospitals, Rainbow Hospitals among others, Niramai provides breast screening services across 19 cities in India.  Niramai also conducts large scale screening camps in association with Karnataka Cancer Society, Rotary International and other socially concerned organizations. With the FDA cleared SMILE-100 System and CE approved Thermalytix products, the company is now taking their Made-in-India innovation to global scale.


About Niramai Health Analytix:

NIRAMAI Health Analytix is a deep-tech healthcare company offering a novel Artificial Intelligence-based devices. Their flagship product is Thermalytix which is radiation-free, non-touch, accurate, breast cancer screening test for women of all age groups. The solution is portable, automated and detects breast cancer at a much earlier stage than traditional screening methods. NIRAMAI was co-founded in July 2016 by Dr. Geetha Manjunath and Ms Nidhi Mathur. NIRAMAI has so far raised a total of $7M from institutional investors from India, Japan and Singapore. Investors include Dream Incubator, BeeNext, pi Ventures, Ankur Capital, Axilor Ventures, 500 Startups, and others.  NIRAMAI has won many international prestigious awards including World Bank instituted Global Women HealthTech Award 2022, National Startup Award 2020 in India, the Gold prize in Hack Osaka 2019 in Japan and and have received research funding from the Bill & Melinda Gates Foundation and CDC UK. Niramai also conducts regular free webinars and awareness talks on breast health and provides a free breast health helpline on Whatsapp number on +91-9483434444.

One Comment
  1. Sasha Ragin

    That is fantastic news! Congratulations!

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