IT Manufacturing Patients Specialization 
The Medical Futurist
JUNE 17, 2025
Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. For patients, it promises more accurate care and better outcomes. How about having a teledentist consultation?
The Medical Futurist
JUNE 21, 2025
The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa. How far can you see and hear? Globally 1.1
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The Medical Futurist
JUNE 21, 2025
Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. ” M-LLM (Translating for Patient): “¿Puede señalar dónde le duele? However, medicine, by nature, is multimodal as are humans.
FDA Law Blog
APRIL 25, 2023
Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. This provision became effective as of March 29, 2023.
FDA Law Blog
MAY 8, 2023
The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.
FDA Law Blog
MAY 19, 2023
In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).
FDA Law Blog
OCTOBER 2, 2024
On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Change Guidance at 8. Draft Guidance at 34.
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