Epic pediatric sepsis alert misses most cases; FDA warns of Lumify ultrasound failures; Stryker puts $400 million into CMR; Google adds AI health trends
Epic pediatric sepsis alert misses most cases; FDA warns of Lumify ultrasound failures; Stryker puts $400 million into CMR; Google adds AI health trends
The voices on this episode are generated, and so is the script, from the day's post at Physician in the Loop. Every fact in the post links to its source.
An 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.
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Voice 1: This is Physician in the Loop, the daily briefing on AI in medicine. It's Tuesday, October 13th, 2026.
Voice 1: An alert built into the Epic record to catch pediatric sepsis caught just 36% of cases, across about 167,000 emergency department visits at eight New York hospitals.
Voice 2: How many of those visits were actually sepsis, and did the alert even agree on what that meant?
Voice 1: Researchers at Columbia University and NewYork-Presbyterian looked at children seen from January 2024 through June 2025. Of all those visits, 189 children met Phoenix criteria for sepsis within 24 hours of arrival, and the alert's positive predictive value was only 3%. It also fired before sepsis onset in 30% of the cases it did catch.
Voice 2: Did it miss some kids more than others?
Voice 1: Sensitivity fell to 22% in Black children, 20% in children under 5, and 25% in emergency departments outside tertiary children's hospitals. The authors said the alert does not support timely or equitable screening.
Voice 2: Epic can't be happy with that.
Voice 1: Epic disputed parts of the study. The company told TechTarget 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.
Voice 2: So some of this might be two definitions talking past each other.
Voice 1: That's Epic's argument. The authors are standing by what they found in their own eight hospitals.
Voice 2: The FDA flagged a different kind of failure this week, in a device meant to work outside the hospital.
Voice 1: Its early alert, issued October 9th, ties software and cable faults in Philips' Lumify handheld ultrasound to four deaths and eight serious injuries.
Voice 2: What actually goes wrong with it?
Voice 1: The Lumify app can stop recognizing a registered transducer and block scanning until the probe is registered again, which needs Wi-Fi or cellular service. The USB link between the probe and the tablet or phone can also drop. Philips reported the deaths and injuries as of September 29th, along with reports of delayed care in ambulances, aircraft, and other field settings.
Voice 2: Why does that matter more here than on a regular cart-based ultrasound?
Voice 1: Because clinicians use Lumify for triage and real-time decisions in mobile and remote care, the FDA said, so losing the ability to scan carries more risk somewhere with poor connectivity, like an ambulance. Philips told MedTech Dive it's developing a software update and has formed a task force to support affected customers. Different kind of money story, this one in surgical robotics.
Voice 2: Stryker is putting about $400 million into CMR Surgical, a British company, and becoming the exclusive U.S. seller of its Versius soft-tissue robot.
Voice 1: What does Stryker actually get for that?
Voice 2: A preferred equity stake announced October 12th, with an exclusive option to acquire all of CMR, subject to regulatory approvals. 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.
Voice 1: Does anyone think this dents Intuitive's position?
Voice 2: Not soon. 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 instead in lower-cost settings like ambulatory surgery centers. Google had its own announcement October 12th, aimed at consumers rather than hospitals.
Voice 1: An about $180 Fitbit tracker called the Edge, with AI features that report trends in blood pressure and insulin resistance in the background.
Voice 2: Is that a real clinical reading?
Voice 1: No. Google's own footnotes say these features are for general wellness only, are not a prescreener for diabetes or hypertension, give no real-time clinical readings, and shouldn't be used to adjust medications. Google published no accuracy data with the announcement.
Voice 2: What's actually behind the blood pressure trend?
Voice 1: A foundation model called WavesFM, trained on heart and movement data. U.S. users will also be able to link Abbott's Lingo glucose sensor and Function Health lab results, with a paid Google Health Premium coach meant to help interpret the trends. Sales start October 27th.
Voice 2: A device with no published accuracy numbers, carrying a label that tells people not to touch their medications because of it.
Voice 1: Before we go, something to watch.
Voice 2: Medicare open enrollment opens October 15th and runs through December 7th. Does that cover everything CMS has been piloting?
Voice 1: No. The watch list specifically notes that ACCESS is Original Medicare only, nothing broader.
Voice 2: And right after that, the American Society of Anesthesiologists holds its annual meeting, ANESTHESIOLOGY 2026, in San Diego, October 16th through the 20th.
Voice 1: Nothing about the agenda yet, just the dates for now.
Voice 2: Two different kinds of dates landing in the same week: one that changes how patients pick coverage, and one that's just a professional meeting on the calendar.
Voice 1: Sources and corrections are at physicianintheloop.org, where you can sign up for the free email briefing. This briefing was read by AI voices.