The White House Office of Management and Budget (OMB) released two memos directed to the heads of all executive branch departments and agencies establishing policies on federal AI use and purchase of AI in government.
The memos, which align with an Executive Order President Donald Trump signed in January, replace former President Joe Biden's previous guidance (M-24-10 and M-24-18) but maintain...
Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals...
A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed tests (LDTs) should be regulated as medical devices.
In a 450-page lawsuit filed by the American Clinical Laboratory Association (ACLA), molecular testing laboratory for infectious diseases...
Vuno invests $2M, sells lung AI in Japan to rival
Vuno has invested in and sold its lung disease diagnosis AI technology in Japan to its rival Korean company Coreline Soft.
The two companies recently entered into a strategic partnership to jointly raise their competitiveness in the growing global medical imaging AI segment.
Vuno invested 3.4 billion won ($2.3 million) in Coreline Soft, to which...
Patient monitoring company Sibel Health, a spin-out of Northwestern University, closed a $30 million Series C equity financing round and received its seventh FDA clearance.
Steele Foundation for Hope led the round with participation by Dräger. Both organizations have been existing investors in the company.
WHAT IT DOES
Chicago-based Sibel Health's FDA-cleared ANNE One platform contains advanced...
EpiWatch, the Apple Watch-based epilepsy management company spun out from Johns Hopkins, announced it received FDA 510(k) clearance for its continuous seizure monitor platform that utilizes the popular wearable to detect and alert for tonic-clonic seizures.
Tonic-clonic seizures, or grand mal seizures, are a type of seizure that affects the whole brain and can cause violent muscle contractions...
LAS VEGAS - At the 2025 HIMSS Global Conference & Exhibition here, Tom Leary, senior vice president and head of government relations at HIMSS, and Jonathan French, senior director of public policy and content development at HIMSS, discussed the organization's role in progressing health technology policy in government.
In their talk, "Forecasting the Global Policy Landscape in 2025," the pair...
LAS VEGAS - At the 2025 HIMSS Global Conference & Exhibition here, Herko Coomans, international digital health coordinator at the Ministry of Health, Welfare and Sport, highlighted the work of the Global Digital Health Partnership (GDHP) worldwide and the aim of the organization.
During his talk, "Digital Health Policy Collaboration on a Global Scale with the GDHP," Coomans said, "Every...
Google has received FDA clearance for its loss of pulse detection feature available on Pixel Watch 3.
The loss of pulse detection technology checks for an individual's pulse. Once it detects signs of a loss of pulse, it activates infrared and red lights to search for additional pulse signals. A motion sensor then checks for signs of movement.
An AI algorithm then analyzes the pulse and movement...
Food and Drug Administration (FDA) staffers reviewing Elon Musk's Neuralink were among those fired as part of widespread layoffs within the Agency.
Musk is in charge of the new Department of Government Efficiency (DOGE), which is directing workforce cuts throughout numerous government agencies.
According to a Reuters report, the cuts affected 20 individuals within the FDA's Office of Neurological...
