Tag:

medical device

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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