FDA
The guidance recommends a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate and implement them, and assess the impact of the changes.
The Agency says AI can transform multiple aspects of healthcare, but it is difficult to fully oversee and regulate the technology without the assistance of all sectors involved.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.
The Home as a Health Care Hub will use augmented and virtual reality to reimagine how the home can become a system that improves health equity.
It has also obtained its third US FDA 510(k) clearance.
The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.
The FDA's Oncology Center of Excellence will use Aetion's Evidence Platform to find and analyze sources of real-world data that could be used for research.
The Class I recall of the DASH system comes days after the company issued a voluntary urgent medical device "correction" for its Omnipod 5 controller.
When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.