The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment, as a qualified drug development tool.
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.
The Foundation for the National Institutes of Health (FNIH) has announced the online publication of the first playbook designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.
When the House Energy and Commerce’s Subcommittee on Oversight and Investigations held its last hearing on the U.S. FDA’s foreign drug inspection program in December 2019, there were “reasons for cautious optimism,” subcommittee Chair Morgan Griffith (R-Va.) said in opening a Feb. 6 hearing on the issue. But in the wake of the pandemic, the optimism is gone.
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool.
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.
The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story.
Court rulings favoring biopharma companies that have challenged the U.S. Department of Health and Human Services’ efforts to force them to unconditionally offer 340B prescription drug discounts to an unlimited number of contract pharmacies could become moot in the future if a bipartisan draft bill becomes law.
A partnership between Gate Neurosciences Inc. and Beacon Biosignals Inc. promises to advance the field of precision psychiatry by using electroencephalogram (EEG) biomarkers to diagnose depression and rapidly assess response to medications. The collaboration will first use Beacon’s U.S. FDA-cleared Dreem 3S headband device and neurobiomarker platform to conduct EEGs in participants in Gate’s phase II trial of zelquistinel, a small-molecule NMDA receptor modulator under development as an antidepressant.
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