FDA approves PASCAL for tricuspid repair; chest x-ray AI flags low ejection fraction; PerQseal Elite approved; Penumbra cleared for DVT

• FDA Oct 21, 2026
  FDA approves Edwards PASCAL Precision system for transcatheter edge-to-edge tricuspid valve repair
  The Food and Drug Administration (FDA) approved Edwards Lifesciences' PASCAL Precision system for tricuspid valve repair, the company said Oct. 21. It is indicated for symptomatic severe tricuspid regurgitation despite optimal medical therapy in patients at intermediate or greater surgical risk, as judged by a multidisciplinary heart team. It becomes a second approved option for tricuspid edge-to-edge repair alongside Abbott's TriClip, TCTMD reported; one-year CLASP IITR data are due at TCT 2026. The FDA also approved PASCAL Ace with Capture Clarity for degenerative mitral edge-to-edge repair, which Edwards said is the first FDA-approved edge-to-edge repair device with fluoroscopic indicators.
  Sources: Edwards Lifesciences, TCTMD
• AI Oct 21, 2026
  Deep learning model detects ejection fraction of 40% or less on chest x-rays with area under the curve up to 0.97
  A deep learning model, DLLV, detected left ventricular ejection fraction of 40% or less on chest radiographs with an area under the curve of 0.86 (95% CI 0.84 to 0.88) in an external tertiary referral cohort and 0.92 to 0.97 in two health checkup cohorts, according to a study published Oct. 21 in Radiology: Artificial Intelligence. It was developed on retrospectively collected radiograph and echocardiogram pairs from 24,674 patients. Prescreening with the model would have reduced echocardiography volume by up to 85% while identifying all 12 and seven individuals with reduced ejection fraction in the checkup cohorts, the authors estimated.
  Sources: Radiology: Artificial Intelligence, PubMed
• FDA Oct 19, 2026
  FDA approves Haemonetics' bioabsorbable PerQseal Elite closure system for large-bore arterial access
  Haemonetics announced Food and Drug Administration (FDA) approval of its PerQseal Elite vascular closure system Oct. 19 for structural heart and endovascular procedures performed with 14 to 22F sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26F from within the vessel, and physicians can confirm hemostasis while maintaining guidewire access, the company said. In the prospective, single-arm, multicenter ELITE arterial study, the rate of VARC-3 major device-related vascular access site complications through 30 days was 0%, according to company-reported results the company said it will present at the Transcatheter Cardiovascular Therapeutics (TCT) conference at the end of October.
  Source: Haemonetics
• FDA Oct 20, 2026
  FDA clears Penumbra's Lightning computer assisted vacuum thrombectomy for deep vein thrombosis
  The Food and Drug Administration (FDA) cleared Penumbra's Lightning computer assisted vacuum thrombectomy (CAVT) technology for deep vein thrombosis (DVT), the company said Oct. 20. Dr. Patrick Muck, a TriHealth vascular surgeon and BOLT-DVT co-principal investigator, said the trial data produced the first cleared DVT indication among mechanical thrombectomy devices. In the company-reported trial, a prospective, multicenter investigational device exemption study, 98% of patients had complete or near-complete thrombus removal, with a median device time of 18 minutes. The 48-hour major adverse event rate was 3.1%, and the re-thrombosis rate within 30 days was 3.9%, the company said.
  Sources: Penumbra, Endovascular Today
• Research Oct 19, 2026
  Point-of-care high-sensitivity troponin cuts emergency stays by 47 minutes in ICare-FASTER trial of 59,980 presentations
  In the ICare-FASTER stepped-wedge cluster-randomized trial at six emergency department sites, point-of-care whole-blood high-sensitivity troponin testing within an accelerated diagnostic pathway reduced length of stay by 13% (95% CI 9% to 16%), or 47 minutes, compared with central laboratory testing, according to results published Oct. 19 in Circulation. The trial included 59,980 emergency department presentations. The 30-day rate of myocardial infarction or cardiac death was 0.39% in both arms, and the authors concluded point-of-care testing in the pathway was safe.
  Sources: Circulation, PubMed
• FDA Oct 22, 2026
  Teleflex Freesolve resorbable magnesium scaffold gets FDA breakthrough device designation for coronary intervention
  Teleflex said the Food and Drug Administration (FDA) granted breakthrough device designation to its Freesolve resorbable magnesium scaffold for use during percutaneous coronary intervention, Cardiovascular Business and Cardiac Interventions Today reported Oct. 22. At 12 months, 99% of the magnesium is resorbed, and the ongoing BIOMAG-III pivotal trial is designed to support a future premarket approval application. The scaffold has CE Mark approval but has not received FDA approval for coronary or below-the-knee procedures.
  Sources: Cardiac Interventions Today, Cardiovascular Business

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