Sujentec's Femtech Healthcare Platform 'Surely Smart' Receives US FDA Approval

Suzentec's female digital healthcare platform 'Surely Smart' is making a full-scale entry into the U.S. market through approval by the U.S. Food and Drug Administration (FDA).

SugenTech Surely Smart.
Photo by SugenTech

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On the 3rd, Suzentec announced that Surely Smart, Surely Smart Ovulation Duo, and Surely Smart Menopause Duo products have received FDA approval.

Surely Smart is a personal home test-based digital healthcare platform launched by Suzentec in November last year. It can measure five types of female hormones related to pregnancy, ovulation, and menopause, including estrogen and progesterone, using urine.

Surely Smart is a femtech product that allows self-diagnosis of physical changes and continuous management of hormone patterns related to pregnancy confirmation, ectopic pregnancy, miscarriage risk management, and menopausal transition through a mobile app. According to the company, it enables early recognition and prevention of menstrual irregularities and premenstrual dysphoric disorder by checking the menstrual cycle.

A Suzentec representative said, "This FDA registration is significant as it not only covers the U.S., which accounts for 40% of the global medical device market, but also fulfills a prerequisite for entering the overseas in vitro diagnostics market. Starting with the U.S. market entry in the second half of the year, we will target growth in the global femtech market."

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