FDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, subject to special controls to ensure safety and effectiveness.
FDA classifies ingestible gastrointestinal blood detection capsules as class II devices, establishing special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
24X National Exchange LLC amends member transaction rebate structures; rule change effective immediately upon filing.
NYSE Arca amends Rule 7.35-E to modify trading halt procedures and notification requirements for listed securities on its exchange platform.
NYSE Stock Exchange proposes amendments to listed company manual Section 802.01C with Commission review period extended beyond standard timeframe.
Cboe BZX Exchange amends its fee schedule to remove a note from the Member Quoting Tier and MPID Quoting Tier, effective immediately upon filing.
NYSE Arca proposes amending Rule 8.201-E to modify generic listing standards for commodity-based trust shares, extending the SEC's review period for this rule change.
NYSE American proposes amending Section 1003 of its Company Guide, with the SEC extending its review period to determine approval or disapproval of the rule change.
Cboe Exchange amends transaction fees for Bitcoin U.S. ETF Index Options (CBTX) and Mini Bitcoin U.S. ETF Index Options (MBTX) effective immediately upon filing.
NYSE National proposes amending Partial Cabinet Solution Bundles trading rules with immediate effectiveness.
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