Our partner Windi Hary and I annotated a recent FDA Warning Letter.  There is much one can learn from Warning Letters and we highly encourage our clients to make review and analysis of warning letters a regular part of your quality program. Click here to download this teaching aid:  Warning Letter – iRhythm Technologies, Inc...Read More

The FDA completed its review of an Automated Ejection Fraction SaMD De Novo leading to a new Class II code, ‘QVD.’  The FDA notice follows including the special controls. FDA Notice Re: DEN220063 Trade/Device Name: Caption Interpretation Automated Ejection Fraction Software Regulation Number: 21 CFR 892.2055 Regulation Name: Radiological machine learning-based quantitative imaging software with...Read More