Breath-hold fails to lift robotic bronchoscopy yield; FDA makes Lumify ultrasound recall Class I; ICU CKRT system is cleared

• Technology Oct 20, 2026
  Breath-hold ventilation does not raise robotic bronchoscopy diagnostic yield in STABLE trial of 117 patients
  In the single-center randomized STABLE trial presented Oct. 20 at CHEST 2026, breath-hold did not significantly change strict diagnostic yield, the primary end point, compared with conventional ventilation during robotic bronchoscopy (86.8% versus 92.2%; P = .338), HCPLive reported. Of 117 patients, 53 received breath-hold and 64 conventional ventilation, using the Noah Galaxy Robotic Bronchoscopy System with integrated augmented fluoroscopy and C-arm-based augmented tomosynthesis. Across both arms, yield was 95.9% with tool-in-lesion and 85.0% with tool-touching-lesion. Dr. Roshen Mathew, who presented, said adding the breath hold "really doesn't make much of a difference."
  Source: HCPLive
• FDA Oct 19, 2026
  FDA classifies Philips Lumify ultrasound software issue as Class I recall; four deaths reported
  The Food and Drug Administration (FDA) updated its Oct. 9 early alert on Oct. 19 to say the Philips Lumify diagnostic ultrasound issue has been classified as a Class I recall, the most serious type. Because of a software issue, users can be prompted to re-register a transducer, and registration requires Wi-Fi or cellular signal access. Philips reported eight serious injuries and four deaths associated with the issue. The FDA told users to always have backup ultrasound devices or modalities available, and Philips said it is developing a software update.
  Source: FDA
• FDA Oct 19, 2026
  FDA clears Fresenius CKRT system with integrated citrate and calcium pumps for patients with acute renal failure
  The Food and Drug Administration (FDA) cleared Fresenius Medical Care's multiFiltratePRO continuous kidney replacement therapy system on Oct. 19, the company said Oct. 21. Its integrated technology eliminates the need for separate citrate and calcium pumps, the company said, during regional citrate anticoagulation in continuous venovenous hemodialysis or hemodiafiltration, for patients weighing 40 kg or more with acute renal failure. Fresenius said the system and its dedicated solutions are the first in the U.S. for on-label regional citrate anticoagulation. The company said its Cienby citrate solution causes hypocalcemia and that severe hypocalcemia can have life-threatening consequences.
  Source: Fresenius Medical Care

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