Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA

Author:

Venkatesh Kaushik P.ORCID,Kadakia Kushal T.,Gilbert StephenORCID

Publisher

Springer Science and Business Media LLC

Reference22 articles.

1. Office of the Commissioner. FDA Roundup: January 16, FDA. https://www.fda.gov/news-events/press-announcements/fda-roundup-january-16-2024 (2024).

2. Chen, S. C. et al. Diagnosing and managing cutaneous pigmented lesions: primary care physicians versus dermatologists. J. Gen. Intern. Med. 21, 678–682 (2006).

3. Guy, G. P. et al. Vital signs: melanoma incidence and mortality trends and projections—United States, 1982–2030. Morb. Mortal. Wkly. Rep. 64, 591–596 (2015).

4. Health C for D and R. Software as a Medical Device (SaMD). FDA. https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd (2024).

5. Health C for D and R. Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices. FDA. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices (2023).

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