FDA clears first AI-based early warning system for sepsis

News brief

Sepsis illustration with iPad and stethoscope — Frank Brennan / iStock

The Food and Drug Administration (FDA) has cleared an artificial intelligence (AI)-based sepsis detection system for approval.

The Targeted Real-Time Early Warning System, developed by researchers at Johns Hopkins University and commercialized by Bayesian Health, integrates electronic health records with advanced clinical AI to continuously monitor patients and flag sepsis up to 48 hours before a clinician suspects it. A 2022 study of more than 764,000 patient encounters at five US hospitals found that when clinicians acted on the tool’s alerts, sepsis patients were 18% less likely to die in the hospital.

Sepsis occurs when the body’s immune system has an overwhelming reaction to an infection, causing a rapid chain of events leading to tissue damage, organ failure, and death. At least 1.7 million US adults and more than 18,000 US children develop sepsis each year, and at least 350,000 adults and more than 1,800 children who develop the condition die during their hospitalization.

A ‘needle-in-a-haystack problem’

Effective treatment and better patient outcomes for sepsis rely on catching it early, which can be difficult because sepsis symptoms, including fever and increased heart rate, are common in other medical conditions. Each hour of delayed treatment can reduce survival by 8%.

Company officials say the platform is the first FDA-cleared, AI-based device that detects sepsis before clinical suspicion.

“Catching sepsis before a clinician suspects it is a needle-in-a-haystack problem,” Neri Cohen, MD, PhD, head of clinical enterprise at Bayesian Health, said in a company press release. “Missing a single case is catastrophic, and that demands a level of precision most AI can't meet, even tools that look promising in preliminary studies."

The receipt of FDA 510(k) clearance means the agency has deemed the device is “substantially equivalent” to a device that’s already on the market.

After a week of rumors, Makary officially out as FDA head

News brief

Stephanie Soucheray, MA

Marty Makary, MD, MPH, is out as Food and Drug Administration (FDA) commissioner, resigning today after a week of speculation that he would soon be fired by President Donald Trump.

Sources told news agencies that Kyle Diamantas, JD, the agency's deputy commissioner for food, will serve as acting commissioner.

On X, a video clip of President Trump was making the rounds this afternoon. Asked if he fired Makary, Trump said, "Well, I don't want to say, but Marty is a great guy. ... He was having some difficulty."

Controversial as FDA director

Makary has been a controversial leader. According to anonymous sources cited by The New York Times, Makary resigned over the administration’s decision to authorize fruit-flavored e-cigarettes, an action he opposed, noting that grape-colored vapes would make the product more attractive to children.

At times he angered Trump and his supporters, and at other times he promoted the Make America Healthy Again (MAHA) agenda, but he angered some in the MAHA movement when the FDA approved updated mRNA COVID vaccines.

“He has offended almost everyone involved in F.D.A. issues, which is not easy to do,” Diana Zuckerman, the president of the National Center for Health Research, told The New York Times.

Hantavirus outbreak grows to 11 cases, 9 confirmed

News brief

Stephanie Soucheray, MA

A Spanish passenger on the MV Hondius cruise ship who was in quarantine at a military hospital in Madrid is now confirmed to have hantavirus, raising the outbreak total to 11 cases, nine of which have been lab-confirmed. The death toll remains at three.

Speaking in Madrid today, World Health Organization Director-General Tedros Adhanom Ghebreyesus, PhD, said, “There is no sign that we are seeing the start of a larger outbreak. But of course the situation could change, and given the long incubation period of the virus, it’s possible we might see more cases in the coming weeks.”

So far no cases have been identified in anyone other than a passenger on the Dutch cruise ship.

Hantavirus symptoms can appear up to 42 days after exposure. Tedros cautioned he would expect more cases in the coming days because of the long incubation period.

Dutch hospital personnel in quarantine

In other updates, a French woman who was on the ship and fell ill while flying to Paris is in stable condition in an intensive care unit. And 12 Dutch hospital staff are in quarantine after incorrectly handling the bodily fluids of a hantavirus patient.

Argentinian officials announced today that, to track the virus, they will be sending a team to a landfill and other locations a Dutch couple visited. Patient zero has been identified as a Dutch man who was an avid birdwatcher. He visited the landfill before boarding the ship. He died from hantavirus infection, as did his wife.

Candidemia cases are rising, becoming deadlier, study finds

News brief

Chris Dall, MA

Candida auris illustration — Stephanie Rossow / CDC

Candidemia incidence and associated 30-day mortality have risen in the United States since 2015, according to a study published yesterday in Clinical Infectious Diseases.

For the study, a team led by researchers with Houston Methodist Hospital examined data from a nationwide database of electronic health records to analyze trends in candidemia incidence from 2015 through 2014.

Candidemia is a severe and life-threatening bloodstream infection caused by species of Candida yeast. Most often found in medically vulnerable and chronically ill patients, Candida species cause an estimated 23,000 bloodstream infections every year in the United States, with mortality rates ranging from 25% to 40%.

The study authors note that the incidence of candidemia and candidemia-related mortality increased during the COVID-19 pandemic, when severely ill, intubated patients spent more time in hospitals. They wanted to see whether those trends have persisted and to assess changes in causative species.

A total of 29,454 candidemia cases were identified among 27,926 patients (mean age, 58.9 years; 55.6% male) across 141 healthcare systems. The overall incidence was 50.5 cases per 100,000 hospital admissions, rising from 42.3 in 2015 to 51.2 in 2024.

Overall 30-day mortality was 31.5%, increasing from 24.7% to 37.6% in 2021, then declining to 31.8%. The most common species was Candida albicans, accounting for 40% of candidemia cases over the study period. The proportion of infections caused by Candida auris, a multidrug-resistant yeast first identified in a US patient in 2016, rose to 4.7% by 2024.

An analysis of C auris patients found they were more likely to be Black, have renal failure, and have a higher Social Vulnerability Index than patients with candidemia caused by other species.

More ICU-acquired cases

The authors say the increase in candidemia-related mortality occurred in parallel with a shift toward intensive care unit (ICU)-acquired cases and a trend toward older patients that began during COVID and has persisted, “despite advances in prevention, diagnostics, and therapy.”

“Overall, these data suggest that candidemia is increasingly affecting medically vulnerable patients at high risk of mortality, such as the critically ill and elderly, and that important healthcare disparities exist with respect to C. auris,” they concluded.