FDA
The technology has a built-in sensor that can send usage data to a corresponding smartphone app.
Both companies are ramping up the pace of their FDA clearances.
The IB-Stim device adheres behind the patient's ear for up to five days, and may assist with pain reduction for up to three consecutive weeks.
The FDA approval closes a gap with competitors Dexcom and Abbott, as well as setting the company up for entry into the Medicare market.
Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.
Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.
To see light as a prescription digital therapeutic for PTSD patients affected by nightmares, NightWare is testing its app among veterans and the general public.
Using devices and systems that have not been authorized by the regulatory agency comes with a risk.
AIdoc's tool flags potential cases of pulmonary embolism to ensure prompt review and intervention.