The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
The first patenting to be published in the name of Wave View Imaging Inc. sees its co-founders file for additional protection of their imaging technology which can be used to monitor breast cancer treatment.
Artificial intelligence might solve a world of cost issues for medical science, but the results of a recent study suggest that the day has not yet come when hospitals and doctor’s offices can just feed data into a computer and expect a reliable and intelligible diagnosis.
In what represents the first patenting to emerge from Braincapture ApS, its chief executive officer, Tue Lehn-Schiøler, describes the development of a low-cost, portable electroencephalogram device designed to enhance neurological diagnostics in underserved communities around the world.
In just the second PCT filing published in the name of Newmanbrain SL, co-founders Carlos Belmonte and Joaquin Ibañez seek specific protection for the use of Newmanbrain’s functional near infrared spectroscopy system, Theia, in the diagnosis of attention deficit/hyperactivity disorder.
A team of researchers from the University of Northumbria filed for protection of a flexible transdermal patch taht uses surface acoustic wave technology they believe offers distinct advantages over traditional transdermal patches.
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
Quantalx Neuroscience Ltd. filed for protection of a system and method for the diagnosis of normal pressure hydrocephalus and prediction of patient response to ventriculoperitoneal shunting surgery treatment. The U.S. FDA granted the company’s Delphi-MD breakthrough device designation for these indications in May 2023.
Lunglife AI Inc. is looking for a strategic partner to help get Lunglb — its non-invasive test for the early detection of lung cancer — into the market and to the patients who need it. The company’s artificial intelligence-supported blood-based test, which identifies indeterminate lung nodules, will be game changing for early lung cancer diagnosis, Paul Pagano, Lunglife CEO, told BioWorld.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike.
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