De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges… Read More »
Carrot, the Redwood City, California-based maker of a smoking cessation app and its paired, FDA-cleared breathalyzer device, announced this week that it has raised $ 25 million in new funding. The investment was led by Johnson & Johnson Innovation (JJDC), with participation from New York Life Ventures, Khosla Ventures, Marc Benioff, R7 Partners and Dr.… Read More »
According to Executive Director PAH-QEII Network at Princess Alexandra Hospital, Dr Michael Cleary, the hospital was identified as a “lead site” in the early days of strategy for the implementation of software. The rollout involved two stages of implementation. The first stage was in 2015, involving the clinical records system but excluding the medications management,… Read More »
Using digital health tech is a new normal for U.S. consumers, including Seniors, found in the 2018 digital health consumer survey from Deloitte. The title of the report, “Consumers are on board with virtual health options,” summarizes the bullish outlook for telehealth. That’s the consumer-demand side of the equation. But the tagline begs the supply… Read More »