As AI and machine learning have become more important for the betterment of healthcare, the introduction of software as a medical device (SaMD) tools has shown promising results for doctors and ...

The data reveals key market opportunities in enhancing compliance through expertise in PMS, PMCF, and vigilance for digital health technologies. Emphasizing real-world data, risk management, and ...

Kal Patel, MD, is CEO and Co-Founder of BrightInsight. He has over 20 years of experience in pharma, medtech and regulated digital health. Software as a Medical Device (SaMD) is changing how patients ...

Technology and healthcare have been going hand in hand for years. The advent of health wearables, 3D printing, robotic surgery and virtual reality in the form of software has been a game-changer in ...

The healthcare industry has always relied on new technology to drive it forward and improve the care that patients get. From the invention of things like the magnifying glass and the stethoscope ...

Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. FDA recently released draft guidelines regarding the use of software as a medical device ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...