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Home » Topics » Regulatory

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Health professional reviewing digital health data

US Senate evaluates site-specific use of AI in health care

Feb. 8, 2024
By Mark McCarty
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
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Toku Clair platform

Toku receives CE, UKCA marks for cardio disease AI risk evaluation tool

Feb. 8, 2024
By Shani Alexander
Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.
Read More
Hand holding empty medicine bottle

Is more visibility the answer to US drug shortages?

Feb. 7, 2024
By Mari Serebrov
Shadowed by prescription drug shortages at their highest level since 2014, the FDA issued a slightly revised version Feb. 6 of a draft guidance it released a year ago to give it more visibility into the U.S. drug supply chain.
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U.S. flag, stethoscope

Budget scoring a concern for breakthrough device coverage legislation

Feb. 7, 2024
By Mark McCarty
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.
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Deliberate AIBehavioral Modalities

Deliberate AI anxiety/depression model accepted into ISTAND

Feb. 7, 2024
By Annette Boyle
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.
Read More
Concept art for adeno-associated viral-based gene therapy.
Drug Design, Drug Delivery & Technologies

New regulatory playbook to guide AAV gene therapy development for rare diseases

Feb. 7, 2024
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.
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Test tubes, dropper and capsules
Cancer

Aprea files IND for WEE1 kinase inhibitor

Feb. 7, 2024
Aprea Therapeutics Inc. has submitted an IND application to the FDA to initiate clinical trials of APR-1051, an oral next-generation small-molecule inhibitor of WEE1 kinase.
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US FDA foreign drug inspections continuing COVID-19 casualty

Feb. 6, 2024
By Mari Serebrov
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.
Read More
Deliberate AIBehavioral Modalities

Deliberate AI anxiety/depression model accepted into ISTAND

Feb. 6, 2024
By Annette Boyle
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.
Read More
Esophageal cancer

Cyted gets FDA approval for capsule sponge device

Feb. 6, 2024
By Shani Alexander
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.
Read More
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