8-K - INNOVATE Corp. | StockGist

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INNOVATE Corp. announced that its equity method investment MediBeacon received EU CE Mark certification under MDR for its TGFR Monitor and Reusable Sensor on March 31, 2026.

Key Takeaways

1MediBeacon, INNOVATE's equity method investment, received EU CE Mark for TGFR Monitor and TGFR Reusable Sensor under EU MDR 2017/745.

2Certification covers two Class IIa devices, enabling potential use in European clinical trials.

3TGFR System assesses kidney function transdermally using Lumitrace injection, approved in U.S. and China.

4CE Mark supports MediBeacon's U.S. and China clinic entry and underscores quality standards commitment.

5Lumitrace EU submission is pending; system includes CE marked Disposable Ring.

Current Report Details

Event Type

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

| Other Events. On March 31, 2026, the Company issued a press release titled "MediBeacon ® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under Eur

Other Event

9.01

| Financial Statements and Exhibits. (d) Exhibits Exhibit No.: 99.1 | Description: Press Release dated March 31, 2026, titled “MediBeacon ® Transdermal GFR Moni

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1