As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.
As medical devices that use artificial intelligence and machine learning appear in more hospitals and imaging labs across the U.S., new data from the Food and Drug Administration show the agency has been fielding more submissions.
In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices, according to data released on Oct. 5. This broad category of devices can include anything from a basic algorithm to more complex machine learning tools, Michaela Miller, U.S. medtech technology and analytics practice leader for IQVIA, a North Carolina-based analytics and clinical research firm, said by email.
MedTech Dive analyzed FDA data on all of the AI- and machine-learning-enabled devices the agency has authorized to date. Follow this link to the full article to read the five takeaways on the rise of these devices.
AI can detect breast cancer signs that radiologists don’t see, new study findsRead Now
Artificial intelligence (AI) is showing promising results in detecting breast cancer which may otherwise have been missed by radiologists, the largest study of its kind has found.
Researchers in Germany discovered that AI can correctly detect interval breast cancers, which develop in between routine screening rounds (usually 24 months in many countries) and can be missed and diagnosed as a false negative result.
In 2020, there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally, according to the World Health Organization (WHO).
The peer-reviewed study showed approximately 16 per cent of interval cancers are probably visible during a previous screening while one in five may be too subtle to the human eye and can be missed by radiologists, which is known as "minimal signs".
The findings present an opportunity to detect more cancers at a screening with AI, which may help detect breast cancer earlier.
Read the full article here.
Artificial intelligence can improve medical imaging for screenings, precision medicine, and risk assessment.