FDA Approves Channel Medystems’ Cerene Endometrial Cryotherapy
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.
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Channel Medysystems’ Cerene cryotherapy for endometrial ablation and Fidia Pharma’s Triluron hyaluronic acid for knee pain.
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.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions, and suspensions each month. This month's edition, covering the period between mid-June and mid-July, represents a wide variety of devices and companies, including many of the biggest medtech players.