Tag:medical device
The FDA Opens a Discussion on Generative AI-Enabled Medical Devices
On August 18, 2026, the Food and Drug Administration (FDA) released a discussion paper and request for feedback on the regulation of generative AI-enabled medical devices. The paper discusses the regulatory considerations specific to generative AI-enabled medical devices, including monitoring after a device is deployed, evaluation of underlying data models, and multiple risk assessments. To support its regulatory efforts, the FDA proposes implementing two processes into their oversight model: a two-axis risk evaluation framework to assess the risk a continuously adapting device may pose and a competency-based approach to measure a device’s effectiveness. Although the discussion does not set forth any proposed regulations, it does invite early feedback from stakeholders. However, the FDA fails to adequately invite and consider feedback from doctors and patients interacting with generative AI-enabled medical devices.
A New FDA Rule Will Change the Future of the Hearing Aid Industry
Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.
FDA Faces Forward with Flexible Genetic Guidance
In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.
Could Apple Dive into the Medical App and Device Market Sooner Than We Think and How Will This New Technology Be Regulated?
Amanda Plowman Executive Editor Loyola University Chicago School of Law JD 2017 Alexander Thompson Assistant Editor Loyola University School of Law JD 2018 Apple has had a longstanding interest in breaking into the healthcare industry. Recently, Apple has hired a Toronto physician to work on expanding its health apps and Aetna will now provide …
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Theranos: New Compliance Program Hopes to Save the Company
Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, JD 2017 Edmund Tyrrell Associate Editor Loyola University Chicago School of Law, JD 2018 Theranos, the American health-tech and medical-lab-services company, recently hired two executives to oversee regulatory compliance standards. The executives were hired following Theranos receiving multiple sanctions from U.S. regulators about the …
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