Regulatory Affairs, SaMD & Digital Health Expert
The Future of Healthcare: How Digital Health is Revolutionizing Patient Care The healthcare industry is rapidly evolving, and one of the most profound changes on the horizon is the integration of digital health technologies into patient care. Digital health, which encompasses a wide range of technologies such as telemedicine, wearable devices, mobile health apps, and …
The Future of SaMD: How Software as a Medical Device is Changing Healthcare Software as a Medical Device (SaMD) is a rapidly evolving field that is transforming the way healthcare is delivered. SaMD refers to software that is intended for medical purposes, such as diagnosing, preventing, monitoring, alleviating, or treating disease, or for supporting, modifying, …
The Impact of Generative AI on Healthcare: Promises and Pitfalls Artificial intelligence has been making significant strides in various industries, and healthcare is no exception. Generative AI, in particular, has the potential to revolutionize the way healthcare is delivered, making diagnosis and treatment more efficient and effective. However, like any other technology, generative AI also …
The Rise of Wearable Medical Devices: A Game-Changer for Healthcare In recent years, there has been a rapid growth in the popularity of wearable medical devices as a game-changer for healthcare. These devices have the potential to transform the way we monitor and manage our health, providing valuable insights and real-time data to both patients …
The FDA 510(k) database is a valuable resource for healthcare professionals and consumers alike. This database contains information on medical devices that have been cleared by the Food and Drug Administration (FDA) through the 510(k) premarket notification process. This process allows manufacturers to demonstrate that their new medical device is substantially equivalent to a legally …