- Strategy
- Payers
- AI
- Cybersecurity
- Device Development
- Studies/Published Research
- Ethics
- Regulatory
- Digital Biomarkers
- Data Science
- Companion Diagnostics
- Clinical Care
- Digital Therapeutics
- Academic Research
- Virtual Reality
- RWE
- Digital Endpoints
- Medical Devices (Class II and Class III)
- Commercialization
- Clinical Trials
- Drug-Device Combinations
- SaMD
- Remote Patient Monitoring
- Patient Engagement
- Profiles/Q&A
FDA Grants 510(k) Clearance to AI Software Quantification for CT-Based Automatic Body Composition Analysis
Medical IP’s software analyzes bone, muscle, fat, organs, and the central nervous system.
The FDA has granted 510(k) clearance to DeepCatch, an AI-powered software used for whole-body composition CT quantification. Developed by Medical IP, the software is able to analyze bone, muscle, fat, organs, and the central nervous system during a whole-body CT.
This clearance opens the door for DeepCatch to enter the medical field in the United States.
In a press release, an official for Medical IP said, “DeepCatch has proven that it provides accurate body composition analysis results to anyone regardless of race, gender, or age. It will contribute to the development of the medical industry through fast, accurate, and efficient CT-based body composition analysis technology.”
The press release also detailed the FDA’s clearance process, which involved testing the software for the accuracy of its analysis. The software confirmed that it can accurately measure the volume and area of various body parts, along with the circumference.
“DeepCatch has proven that it provides accurate body composition analysis results to anyone regardless of race, gender, or age,” Medical IP CEO Joon S. Park said in the press release. “It will contribute to the development of the medical industry through fast, accurate, and efficient CT-based body composition analysis technology.”
