Speaking Of Medtech, Ep. 4: FDA’s Regulation Of Digital Devices

According to a survey of health care professionals by J&J, over 45% of surveyed respondents reported experiencing symptoms of burnout, including emotional exhaustion and reduced sense of personal accomplishment. This affects not just clinicians, but also the quality and safety of care they deliver. Most clinicians (72%) say that data and technology could significantly help alleviate this burden.

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.