Benzinga·2025-11-28 09:49Core Insights - Heartbeam Inc's shares increased significantly by 43.3% to $0.86 in pre-market trading following the announcement of its regulatory strategy after the FDA's Not Substantially Equivalent decision on its Electrocardiogram Synthesis Software [1][2] Company Developments - Heartbeam is exploring multiple regulatory options, including an appeal process or a 510(k) resubmission to demonstrate that its device is equivalent to legally marketed products [1] Market Movements - Other notable pre-market stock movements include: - SMX PLC surged 73.1% to $30.12 after a previous jump of 194% [6] - Zenta Group Co Ltd gained 26.7% to $3.18 [6] - Waton Financial Ltd rose 21.1% to $3.74 [6] - Verrica Pharmaceuticals Inc increased by 9.7% to $7.36 after announcing a $50 million private placement [6] - Conversely, several companies experienced declines, such as: - FBS Global Ltd fell 24.3% to $0.51 [6] - Tilray Brands Inc declined 15% to $0.88 following a reverse stock split announcement [6] - Solo Brands Inc dipped 14.4% to $7.19 after reporting disappointing third-quarter results [6]