HeartSciences Inc.: FDA grants 510(k) for MyoVista wavECG

What happened The company announced on Oct 6, 2026 that the U.S. Food and Drug Administration has granted 510(k) clearance (K260005) for HeartSciences’ MyoVista wavECG device as a 12-lead resting electrocardiograph. The press release announcing the clearance is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The filing also reported that, as previously disclosed, on Jun 23, 2026 HeartSciences, Fortitude Mining Holdings, Inc., Fortitude Mining HoldCo, LLC and Cordis Acquisition, LLC entered into an Agreement and Plan of Merger, as amended, relating to their proposed business combination.

Key details

• 510(k) number: K260005.
• Device: MyoVista wavECG, described as a 12-lead resting electrocardiograph.
• Press release date: Oct 6, 2026; furnished as Exhibit 99.1 to the Form 8-K.
• Merger agreement date: Jun 23, 2026; parties include Fortitude Mining Holdings, Inc., Fortitude Mining HoldCo, LLC and Cordis Acquisition, LLC.

Why it may matter This disclosure was reported under Item 7.01, Regulation FD Disclosure, which covers public disclosures the company announced under Regulation FD. A filing does not show why the insider traded or why the company acted.