The agency took issue with distracting visuals and reliance on superimposed text in a television spot for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug. This is the third untitled letter from the US FDA to target promotions for women’s health products in the past eighteen months.

‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.

Cerene is indicated for endometrial cryoablation in premenopausal women. Channel's PMA is based on 12-month results from the CLARITY trial, which showed procedural success with Cerene in about 77% of patients.

Femtech, which describes digital technologies that aim to improve women's health, is expected to reach $50bn in market size by 2025, according to Frost & Sullivan. Reproductive health and menstrual health trackers are two of the fastest-growing sectors in femtech. We've highlighted some of the biggest players in both segments, their innovative business models, plans and also looked at barriers such as privacy issues, accuracy of mobile applications and funding challenges.