Urology fellow, Jeremy Fallot, and nurse, Shauna Harnedy, assist in robotic surgery by Ruban Thanigasalam (out of view) in Sydney, Australia.Credit: Ken Leanfore for Nature Loved by surgeons and patients alike for its ease of use and faster recovery times, the da Vinci surgical robot is less invasive than conventional procedures, and lacks the awkwardness of laparoscopic (keyhole) surgery. But the robot's US$2-million price tag and negligible effect on cancer outcomes is sparking concern that it's crowding out more affordable treatments. There are more than 5,500 da Vinci robots globally, manufactured by California-based tech giant, Intuitive. The system is used in a range of surgical procedures, but its biggest impact has been in urology, where it has a market monopoly on robot-assisted radical prostatectomies (RARP), the removal of the prostate and surrounding tissues to treat localized cancer. Uptake in the United States, Europe, Australia, China and Japan for performing this procedure has been rapid.

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users--both healthcare professionals, and patients and caregivers. It also provides guidance on FDA's interpretation of new software provisions in Section 3060 of the 21st Century Cures Act. Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Industry has been innovating and evolving rapidly.