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.
Kardia Band attaches to the Apple Watch like any other replaceable watch band. The user rests a finger on the sensor pad embedded in the band, allowing an EKG reading to be taken. The Kardia Band transmits its EKG reading to the Apple Watch (via a high-pitch audio signal) where it's displayed in real time as a moving waveform. When the 30-second EKG is finished, the user can view it on their phone or easily send the results as a PDF to their physician.
Surgeons are trained to accurately operate on you when you need it, but robotic assistants could help them get to hard-to-reach areas and boost their accuracy even more. Senhance, the robotic surgical assistant that has just earned the FDA's approval, was designed to accomplish both of those. The machine can help surgeons carry out minimally invasive surgery -- in fact, the FDA has approved its use because after a pilot test involving 150 patients, the agency has concluded that Senhance is as accurate as the da Vinci robot when it came to gynecological and colorectal procedures. According to TransEnterix, the company that developed the machine, it's the first surgical assistant for the abdominal area to get the FDA's approval since 2000. The company claims it's also the first one with eye tracking and force feedback.
The FDA approved the country's first human-interacting autonomous robot for hospitals on Thursday. The RP-VITA, made by iRobot (best known to consumers as the makers of the Roomba) and InTouch Health, is a human-sized telepresence robot which allows doctors to remotely interact with hospital patients. The robot can navigate hospital corridors autonomously, while medical professionals talk and interact with patients through a special iPad app. The Food and Drug Administration has given the RP-VITA full 510(k) clearance for hospital use.