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FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation

The Directory / Cardiovascular

Cardiovascular Digital Health & SaMD

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Seed · De Novo granted

Builds PMcardio, an ECG interpretation platform whose Queen of Hearts model reads 12-lead ECGs for heart attack patterns. FDA granted it a De Novo under DEN250044 in September 2026.

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