Epic pediatric sepsis alert misses most cases; FDA warns of Lumify ultrasound failures; Stryker puts $400 million into CMR; Google adds AI health trends
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read by AI voices ยท all episodesAn Epic Systems alert for pediatric sepsis caught 36% of cases across eight New York emergency departments, researchers from Columbia University and NewYork-Presbyterian reported Oct. 5 in JAMA Pediatrics; Epic disputed parts of the study.
The Food and Drug Administration issued an early alert Oct. 9 tying a software and cable problem in Philips' Lumify handheld ultrasound to four deaths and eight serious injuries, with the greatest risk in ambulances and other places with poor connectivity. Stryker agreed Oct. 12 to invest about $400 million in CMR Surgical and become the exclusive U.S. seller of its Versius soft-tissue robot, and Google introduced a Fitbit tracker that reports AI-derived blood pressure and insulin resistance trends under a general wellness label.
The FDA also cleared Click Therapeutics' Motivista, a prescription smartphone app and the first authorized treatment for the negative symptoms of schizophrenia. The Epic, Lumify and Motivista items were first reported last week and run here as catch-up items.
- FYIEvidence Oct 5, 2026The retrospective study covered children seen from January 2024 through June 2025 in eight emergency departments of one New York health system; 189 met Phoenix criteria for sepsis within 24 hours of arrival. The alert's positive predictive value was 3%, and it fired before sepsis onset in 30% of cases, the authors reported. Sensitivity fell to 22% in Black children, 20% in children under 5 and 25% in emergency departments outside tertiary children's hospitals, and the authors said the alert does not support timely or equitable screening. Epic told TechTarget that the model was developed at Nationwide Children's Hospital, that each organization validates and configures it for its own patients and that the study measured it against Phoenix criteria, which define sepsis differently.
- ActIncident Oct 9, 2026
The FDA recommends using Lumify only where Wi-Fi or cellular signal is available, unless backup ultrasound is immediately at hand, until Philips issues an update.
The Lumify app can stop recognizing a registered transducer and block scanning until the probe is registered again, which requires Wi-Fi or cellular service, and the USB link between probe and tablet or phone can drop, the FDA said Oct. 9. Philips reported the deaths and injuries as of Sept. 29 and has received reports of delayed care in ambulances, aircraft and other field settings. The agency said a loss of scanning matters more for Lumify than for conventional ultrasound because clinicians use it for triage and real-time decisions in mobile and remote care. Philips told MedTech Dive it is developing a software update and has formed a task force to support affected customers. - FYIMoney Oct 12, 2026The preferred equity investment, announced Oct. 12, gives Stryker an exclusive option to acquire all of the British company and is subject to regulatory approvals, the companies said; CMR keeps development and sales outside the United States. The FDA cleared CMR's latest system for gallbladder procedures in 2025, and the company plans to seek more soft-tissue indications, MedTech Dive reported. J.P. Morgan analyst Robbie Marcus wrote that Stryker and CMR are unlikely to displace Intuitive's da Vinci in the United States soon and may start in lower-cost settings such as ambulatory surgery centers, according to MedTech Dive.Sources: Stryker, MedTech Dive
- FYIDeployment Oct 12, 2026Google announced the tracker Oct. 12, with store sales from Oct. 27, and said its Health Guardian features follow shifts in blood pressure and insulin resistance in the background, with a paid Google Health Premium coach to help interpret them. Footnotes to the announcement say the features are for general wellness, are not a prescreener for diabetes or hypertension, give no real-time clinical readings and should not be used to adjust medications. Google published no accuracy data with the announcement. The blood pressure trends rest on a foundation model called WavesFM trained on heart and movement data, and U.S. users can link Abbott's Lingo glucose sensor and Function Health lab results, Fierce Healthcare reported.Sources: Google, Fierce Healthcare
- FYIRegulation Oct 5, 2026The 510(k) clearance, announced Oct. 5, covers adults with clinically stable positive symptoms who use the prescription smartphone app alongside clinician-managed antipsychotic treatment, Psychiatric Times reported. In the phase 3 CONVOKE trial of 457 patients at 66 U.S. sites, the app lowered the CAINS-MAP motivation and pleasure score by 6.8 points at 16 weeks, against 4.2 points for a digital control app, an effect the authors called small to moderate in JAMA Network Open; no serious adverse event was treatment related. Click has set no price and plans a state-by-state launch that follows insurance coverage, according to Fierce Biotech.