FDA digital health

FDA looks to restrict older predicate devices, introduce new regulatory pathway
By Dave Muoio | 02:34 pm | November 27, 2018
To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old. 
FDA wellness clarifications helpful, accessory proposal is just a start
By Brian Dolan | 08:23 am | January 20, 2015
Bradley Merrill Thompson At the end of last week the FDA posted two draft guidance documents related to digital health.
Verizon shutters Virtual Visits and its FDA-cleared telehealth hub app
By Brian Dolan | 07:07 am | January 12, 2015
Last year Verizon stopped offering both its patient-to-provider Virtual Visits product and its FDA-cleared telehealth hub software.
LifeWatch gets FDA clearance for adhesive, remote patient monitoring wearable
By Jonah Comstock | 10:39 am | December 22, 2014
Vital Connect's HealthPatch, which partnered with LifeWatch last month Swiss remote cardiac monitoring company LifeWatch has received FDA 510(k) clearance for LifeWatch VSP (Vital Signs Patch), the company's adhesive patch for remote patient monitoring.