In a wise move from Owlet Inc.’s point of view, the U.S. FDA cleared the company’s Babysat pulse oximetry sock for infants. The wire-free sock design permits safe and comfortable medical-grade monitoring for infants who might otherwise require extended hospitalization.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the fourth from the company and its partners to notch breakthrough status.
The U.S. Federal Trade Commission (FTC) reported a settlement with San Francisco-based 1Health.io Inc. for allegations that the consumer gene testing company failed to properly secure customers’ data, an oversight that will cost the company only $75,000 in fines.
A graphene-based electronic biosensor platform from Paragraf Ltd. simultaneously detected both protein antigen and RNA biosignals from samples in real time, according to a study published in Advanced Materials Technology. Paragraf claimed that the achievement is a world first, and the development of the platform, which can be quickly adapted for multiomics and multiplexed diagnosis of continuously evolving biothreats and global pandemics, is a major breakthrough.
Avenda Health Inc. reported new study results showing its Unfold AI platform, which uses artificial intelligence (AI) to map a tumor’s location within the prostate, encapsulates all of the clinically significant cancer present in the gland more effectively than standard care.
Aptamer Group plc and Neuro-Bio Ltd. have developed Optimer binders which could enable the creation of a lateral flow test for the early diagnosis of Alzheimer’s disease. Aim-listed Aptamer saw its share price soar on the news as early detection of Alzheimer could bring substantial benefits to patients, caregivers and health care systems and there is currently a lack of tests available for early stage diagnosis of the disease.
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.
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