NEJM paper calls for more regulation of mobile health apps

With the rise of high-risk, high-reward mobile health devices and apps, the FDA needs to add funding and tools towards regulation of the rapidly expanding industry, experts wrote in the New England Journal of Medicine. While most mHealth devices have relatively low risk, health monitoring devices are within FDA jurisdiction and authority. Some believe that FDA regulation will stifle innovative mHealth production, but experts argue that removing FDA oversight will only allow for ineffective and risky devices to infiltrate an unchecked market. Abstract

Suggested Articles

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.

Akoya Biosciences raised $50 million to help boost its commercialization in research, drug development and clinical testing markets.