We are one step closer to achieving a crucial goal – obtaining FDA certification. In our unwavering commitment, we have reached a new milestone. We have successfully undergone a highly significant electromagnetic compatibility (EMC) compliance study, basic safety tests, and performance evaluations conducted by one of ASCA-accredited research laboratories (UL Solutions). The studies were conducted in accordance with rigorous medical device standards (ISO 60601-1, ISO 60601-1-11, ISO 60601-1-2, ISO 60601-2-37), fully confirming that the Pregnabit Pro devices and PregnaOne platform have received full compliance confirmation. This signifies that we fulfill the additional requirements necessary to obtain approval from the U.S.
Food and Drug Administration (FDA) to introduce modern patient care methods through Nestmedic products for use by American doctors and, above all, their patients.
Obtaining FDA certification will enable Nestmedic to commercialize its offerings in the American market. The value of telemedicine services in the United States is estimated to exceed $150 billion USD by 2030, indicating a strengthening trend in telemedicine. It’s worth noting that in 2022, North America held a 36% share in the global telemedicine market, corresponding to nearly $23 billion USD. Nestmedic remains committed to meeting all formal requirements aimed at initiating sales in the USA, thereby aligning with this growing trend. We continue to strive for providing access to innovative solutions for women’s health worldwide.
