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Shares of Heartbeam Inc (NASDAQ:BEAT) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.

The Santa Clara-based medical technology company is pursuing multiple options, including an appeal process or a 510(k) resubmission, a premarket FDA filing showing the device is equivalent to legally marketed products.

Heartbeam shares jumped 43.3% to $0.86 in the pre-market trading session.

Here are some other stocks moving in pre-market trading.

Gainers

• SMX (Security Matters) PLC (NASDAQ:SMX) surged 73.1% to $30.12 in pre-market trading after jumping 194% on Wednesday.
• Zenta Group Co Ltd (NASDAQ:ZGM) gained 26.7% to $3.18 in pre-market trading after rising 4% on Wednesday.
• Waton Financial Ltd (NASDAQ:WTF) gained 21.1% to $3.74 in pre-market trading after rising 10% on Wednesday.
• CDT Equity Inc (NASDAQ:CDT) rose 22.1% to $2.53 in pre-market trading after gaining over 12% on Wednesday.
• Top KingWin Ltd (NASDAQ:WAI) rose 11.2% to $2.87 in pre-market trading after gaining 18% on Wednesday.
• Verrica Pharmaceuticals Inc (NASDAQ:VRCA) rose 9.7% to $7.36 in pre-market trading after gaining 31% on Wednesday. Verrica Pharmaceuticals recently announced a $50 million private placement to retire debt and extend its cash runway.
• TMC the metals company Inc (NASDAQ:TMC) gained 15.3% to $6.72 in pre-market trading after rising 7% on Wednesday.
• Standard Biotools Inc (NASDAQ:LAB) gained 11.2% to $1.59 in pre-market trading.
• Beyond Meat Inc (NASDAQ:BYND) gained 5% to $1.07 in pre-market trading after jumping 19% on Wednesday.

Losers

• FBS Global Ltd (NASDAQ:FBGL) tumbled 24.3% to $0.51 in pre-market trading.
• Tilray Brands Inc (NASDAQ:TLRY) declined 15% to $0.88 in pre-market trading after the company announced a 1-for-10 reverse stock split.
• Solo Brands Inc (NYSE:SBDS) shares dipped 14.4% to $7.19 in pre-market trading after gaining 5% on Wednesday. Solo Brands recently reported worse-than-expected third-quarter financial results.
• Zynex Inc (NASDAQ:ZYXI) fell 12.6% to $1.39 in pre-market trading after gaining more than 115% on Wednesday. Zynex recently reported worse-than-expected third-quarter financial results.
• Pasithea Therapeutics Corp (NASDAQ:KTTA) fell 12.3% to $0.93 in pre-market trading after jumping 117% on Wednesday.
• Direct Digital Holdings Inc (NASDAQ:DRCT) dipped 11.5% to $0.13 in pre-market trading. The company filed a Form 8-K with the Securities and Exchange Commission (SEC) on Wednesday, revealing it reached a settlement agreement last week with Continuation Capital Inc.
• ECD Automotive Design Inc (NASDAQ:ECDA) fell 9.8% to $0.48 in pre-market trading after declining 4% on Wednesday.
• Tevogen Bio Holdings Inc (NASDAQ:TVGN) fell 8.1% to $0.44  in pre-market trading after gaining 10% on Wednesday.
• Inventiva ADR (NASDAQ:IVA) fell 7.4% to $4.26 in pre-market trading after gaining 4% on Wednesday.
• Anglogold Ashanti PLC (NYSE:AU) dipped 5.5% to $83.97 in pre-market trading after gaining over 5% on Wednesday.

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