Manufacturing Medical 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.
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.
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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. Current medical AIs only process one type of data, for example, text or X-ray images. 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.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,
FDA Law Blog
OCTOBER 2, 2024
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. FDA, Guidance for Industry, The Special 510(k) Program (2019). By Adrienne R. Draft Guidance at 34. For 510(k) devices, a PCCP may be submitted only with a traditional or abbreviated application.
FDA Law Blog
MAY 8, 2023
Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,
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