A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.
Gamma imaging is about to move out of the centralized nuclear medicine department and to the point of care, with the start of a U.S. study of a portable device Seracam, under development by Serac Imaging Systems Ltd. The study, at Ohio State University, will compare the performance of Seracam to its larger, fixed, counterpart in imaging the same patients, on the same day.
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
After winning a brutal proxy battle led by activist investor Carl Icahn, Francis deSouza suddenly resigned as CEO and as a member of the board of Illumina Inc. over the weekend. The company appointed General Counsel Charles Dadswell to serve as the interim CEO while it evaluates internal and external candidates for the position. DeSouza will continue in an advisory role until July 31.
Biosency SAS recently unveiled the latest results on its predictive digital medical device for remote monitoring of patient suffering from chronic obstructive pulmonary disease (COPD). The Bora platform demonstrated its ability to predict COPD exacerbation on average three days prior to hospitalization.
An artificial intelligence (AI) framework developed by researchers in Denmark has outperformed human emergency call handlers in identifying stroke. The AI tool has the potential to play a critical role in helping to address the number of strokes that go unrecognized as the number of strokes are projected to increase as the population ages.
Asep Medical Holdings Inc. reported “ground-breaking” use of artificial intelligence in its SepsetER test to rapidly identify infections at increased risk of severe sepsis. Developed under guidance by Professor Robert E.W. Hancock at the University of British Columbia, analysis of dysfunctional immune responses to identify particular sets of genes could signal when a patient is at risk of acquiring and potentially dying from severe sepsis.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
AC Immune SA has patented 4h-imidazo[1,5-b]pyrazole derivatives and labeled compounds targeting α-synuclein (SNCA). They are reported to be useful for diagnosis of multiple system atrophy, Parkinson’s dementia, Lewy body dementia, Alzheimer’s and Parkinson’s disease, among others.
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