Femasys (NASDAQ: FEMY) secures FDA clearance for next-generation FemVue diagnostic

Rhea-AI Filing Summary

Femasys Inc. reported that it has secured U.S. FDA clearance for its next-generation FemVue diagnostic device. This clearance means the updated FemVue system has met the agency’s requirements for marketing in the United States. The company disclosed the news through a press release, which is included as an exhibit to this report.

The FemVue device is described as a diagnostic product, and the clearance relates specifically to its next-generation version. While no financial figures or commercial details are provided here, obtaining FDA clearance is often an important regulatory milestone for a medical device company, as it allows the cleared product version to be offered to healthcare providers in the U.S.

Positive

• FDA clearance for next-generation FemVue device confirms U.S. regulatory approval for the updated diagnostic product, representing a key milestone for Femasys’ medical device portfolio.

Negative

• None.

Insights

Medical device regulatory and equity analyst

Femasys received U.S. FDA clearance for its next‑generation FemVue diagnostic device.

The company states that it has secured U.S. FDA clearance for a next-generation version of its FemVue diagnostic device. For a medical device company, such a regulatory outcome is a key step, because it authorizes marketing of the cleared device configuration in the United States under the conditions recognized by the FDA.

The report does not describe the technical changes in this next-generation FemVue or provide revenue expectations, but it does formally confirm the clearance status. The impact will depend on how quickly Femasys can integrate this cleared version into clinical use and how healthcare providers adopt it, details that may be addressed in the referenced press release or future company disclosures.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 18, 2025

Femasys Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40492	11-3713499
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100 Suwanee, Georgia		30024
(Address of principal executive offices)		(Zip Code)

(770) 500-3910

(Registrant’s telephone number, including area code)

n/a

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		FEMY		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 8.01 Other Events

On December 18, 2025, Femasys Inc. (the “Company”) issued a press release announcing that Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release of Femasys Inc. dated December 18, 2025.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

 SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Femasys Inc.
	By:	/s/ Kathy Lee-Sepsick
	Names: Kathy Lee-Sepsick
	Title: Chief Executive Officer
Date: December 18, 2025

FAQ

What did Femasys Inc. (FEMY) disclose in this report?

Femasys Inc. disclosed that it has secured U.S. FDA clearance for its next-generation FemVue diagnostic device and furnished a related press release as an exhibit.

What is the significance of FDA clearance for Femasys’ FemVue device?

FDA clearance indicates that the next-generation FemVue diagnostic device has met U.S. regulatory requirements, allowing Femasys to market this version of the product in the United States.

Does the filing provide financial details about FemVue for Femasys (FEMY)?

The report focuses on announcing U.S. FDA clearance for the next-generation FemVue diagnostic device and does not present financial figures or revenue projections related to the product.

How did Femasys communicate the FemVue FDA clearance to investors?

Femasys communicated the clearance through a press release titled that it secured U.S. FDA clearance for its next-generation FemVue diagnostic device, which is furnished as Exhibit 99.1.

Who signed the Femasys Inc. (FEMY) report about the FemVue FDA clearance?

The report was signed on behalf of Femasys Inc. by Kathy Lee-Sepsick, the company’s Chief Executive Officer.