Femasys Gets FDA 510(K) Clearance For Infertility Treatment
By Stephen Nakrosis
Femasys said Monday it received clearance from the Food and Drug Administration for the commercialization of FemaSeed, an artificial insemination option.
The biomedical company said FemaSeed is "designed to deliver sperm directly to where conception occurs in a woman's fallopian tube." The FemaSeed procedure works synergistically with the company's FemVue product, an FDA-cleared diagnostic device that enables an in-office ultrasound assessment of the fallopian tubes.
Section 510(k) of the Food, Drug and Cosmetic Act requires manufacturers to give the FDA 90 days advance notice before they can market a medical device.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
September 25, 2023 18:20 ET (22:20 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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