Meanwhile, here are a few of the more interesting things than flu that occurred this week. One would think that this week might be called “Device Week at FDA”:
- First 3-D Mammography Approved – On Friday of this week, the agency announced that it was approving the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. According to the FDA release, while the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.
- FDA Clears First Diagnostic Radiology Application for Mobile Devices – The agency appears to be waking up to the fact that people are using apps and has approved the first which will be used in diagnostic radiology. The applis the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET).The app will will allow physicians to view medical images on the iPhone and iPad. Apps of all kinds are moving forward with lightning speed, the agency has not.
- FDA Launches Medical Device Innovation Initiative – This week the agency proposed the Innovation Pathway (another pathway!), which they state is a priority review program for new, breakthrough medical devices. At the same time, they also announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. Proposed actions resulting from the new pathway include: (1) establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages; (2) creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and (3) using more device experience and data collected outside the United States. The agency said it will continue to take in public comment on this initiative. They also produced a video on this, but be warned, it is a whopping 53 minutes long. (What were they thinking?) Still, it got over 10,000 views this week. I tried embedding it, but the code would not work so there is a link directly to the FDA’s YouTube channel.