Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern predicate devices as well as objective safety and performance criteria during regulatory submission.
In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren,...
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
Last year Verizon stopped offering both its patient-to-provider Virtual Visits product and its FDA-cleared telehealth hub software. This moves Verizon away from end-to-end telehealth products and re-focuses it on providing its healthcare customers HIPAA-ready cloud services, advanced security services, and various mobility solutions.
MedCity News first reported on one of the telehealth product...
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.
"Being small in size, easy to affix, comfortable to wear and far less restrictive and cumbersome than numerous wired devices currently used,...
