Shares of Sugentech, an in vitro diagnostics manufacturer, shot up on Monday after the company announced that it "registered" its digital healthcare platform, Surearly SMART, with the U.S. FDA.

In the press release, the company said it received FDA approval but Korea Biomedical Review has learned that it was not approval but "registration."

As of 3:09 p.m. on Monday, Sugentech shares  on the tech-heavy Kosdaq were up 10.62 percent to trade at 8,960 won ($6.8).

The latest approval encompasses Sugentech's Surearly SMART Ovulation DUO, and Surealry SMART Menopause DUO products.

Surearly SMART is a personalized home test-based digital healthcare platform launched by Sugentech in November 2022. It allows users to measure five female hormones, including estrogen and progesterone, as well as hormones related to pregnancy, ovulation, and menstruation, using urine.

Surealry SMART is a “femtech” product that allows users to self-diagnose physical changes and continuously manage hormonal patterns such as pregnancy confirmations, ectopic pregnancies, miscarriage risk management, and menopause transition through a mobile app.

Additionally, menstrual irregularities and premenstrual dysphoric disorder (PMDD) can be caught at an early stage through menstrual cycle checks, to enable a proactive environment toward women’s health issues.

According to Global Market Insights, the global “femtech” market is expected to grow from $22.5 billion in 2020 to more than $65 billion by 2027.

"Surearly SMART applies an ultra-compact, low-power analysis system based on immunochemistry principles,” said a company official. “This FDA approval will accelerate our entry not only into the U.S. market but also into the global medical device market.”

The company will continue growing and targeting the global “femtech” market starting with the entry into the US market in the second half of the year, added the official.