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 ...

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 integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...

Over the years, patient care delivery has transitioned from simple sense measurement (touch, smell, sight) to more complex devices and thereafter to smart software systems. This shift aims to improve ...

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 ...

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 ...

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 ...