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The FTC, Department of Justice (DOJ) and HHS have jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over healthcare, further signaling the Biden administration’s commitment to lowering healthcare costs. Read More
With stern warnings of potential seizure, injunctions and civil money penalties for failure to comply, the FDA’s warning letter to Fresenius Kabi’s spells out multiple areas in need of corrective action in the company’s manufacture of its Ivenix infusion system components. Read More
Digital health technologies are uniquely effective tools for screening, diagnosing, and managing both type 1 and type 2 diabetes, according to stakeholders who commented in response to the FDA’s request for input on digital health technologies (DHT) for detecting prediabetes and undiagnosed type 2 diabetes. Read More
GE HealthCare subsidiary, Datex-Ohmeda’s recall of EVair and Jun-air compressors has been deemed Class I by the FDA due to potentially elevated levels of formaldehyde emissions. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Read More
This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Read More