Form 8-K Cue Health Inc. For: Jun 06
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM |
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 6, 2023
(Exact name of Registrant, as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
Mailing address:
(Address of principal executive
offices)
Registrant's telephone number, including area code: (858 ) 412-8151
Former name or address, if changed since last report: Not Applicable.
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 Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
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 7.01 Regulation FD Disclosure
On June 6, 2023, Cue Health Inc. (the "Company") issued a press release announcing that it received De Novo authorization from the U.S. Food and Drug Administration ("FDA") for the Company's COVID-19 Molecular Test, designed for both home and point-of-care use. This is the first FDA De Novo authorization for a home use COVID-19 test and the first De Novo granted for any home use respiratory test.
A copy of the Company's press release dated June 6, 2023 announcing the Company's receipt from the FDA of De Novo authorization for the Company's molecular test to detect the COVID-19 virus is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 7.01.
The information contained in Item 7.01 of this Current Report on Form 8-K, including the information contained in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of such section, and such information shall not be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended.
8.01 Other Events
On June 6, 2023, the Company received De Novo authorization from the FDA for the Company’s COVID-19 Molecular Test, designed for both home and point-of-care use.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. | Description | ||||
Press release issued by Cue Health Inc. dated June 6, 2023 | |||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
Cue Health Inc.
Date: June 6, 2023 | By: | /s/ Aasim Javed | ||||||
Name: | Aasim Javed | |||||||
Title: | Chief Financial Officer |
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ATTACHMENTS / EXHIBITS
XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT
XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT
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