JD Supra6h
FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
Sculpt, smooth, and tone at home with this FDA-cleared device
TL;DR: The Fat Iron Pro for $297.99 is designed to reduce the appearance of cellulite, wrinkles, and body fat. Spending a ...
STAT7d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
MassDevice1d
The top 10 cardiac device stories of 2024
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
JD Supra1d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
Healio3d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
Modern Healthcare10d
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
Healthcare Dive10d
FDA aims to stem AI device bias, boost transparency in draft guidance
In particular, the guidance outlines how device makers should address transparency and bias and when postmarket monitoring is needed. Troy Tazbaz, director of the FDA’s Digital Health Center ...