Tag: Medical devices
FDA to strengthen oversight of medical devices
August 26, 2024HME News Staff
WASHINGTON – The Food and Drug Administration has begun building a surveillance system to look for potential safety issues in medical products ranging from surgical masks to implantable pacemakers.
More than 1.7 million injuries and 83,000 deaths over a recent 10-year period in the U.S. have been potentially linked to faulty medical devices, according to a 2018 study by the Government Accountability Office.
Active postmarket surveillance involves the ongoing review of evidence—derived...
Philips reduces activities in Russia
December 6, 2022HME News Staff
AMSTERDAM – Philips released a statement on Dec. 5 condemning Russia’s military aggression against Ukraine. The company says it has substantially reduced its activities in Russia since February, including stopping shipments of its consumer health products (except for certain baby care products), suspending marketing activities and winding down R&D activities. “We are focusing our remaining activities in Russia on the delivery of medical systems, devices and spare parts to health...
Arcadia, Amazon launch Choice
October 30, 2018HME News Staff
SEATTLE - Arcadia Group has launched an Amazon-exclusive brand of consumer-use medical devices for diabetes and hypertension management.
The Choice brand will start with a range of blood glucose and blood pressure monitors, both with supporting mobile apps offering tracking, data mobility and reminders.
“The Choice brand is all about accessible wellness,” said Bob Guest, CEO of Arcadia Group. “Consumers no longer need to drive to a store to stand in line and purchase their...