Category: Standards

Standards

Who Has the Right to Repair Medical Equipment?

As the Right to Repair movement gains momentum, a Proto article asks, should hospitals be allowed to fix machines themselves?

Standards

Elite Medical Experts Weighs in on Philips’ Recall of Breathing Machines That May Emit Toxins

Elite Medical Experts shares its take on the voluntary recall of specific Philips Respironics ventilators, BiPAP, and CPAP devices.

Standards

FDA Issues Updated Recommendations for Bronchoscope Reprocessing

The U.S. FDA has issued a safety communication providing new recommendations for bronchoscope reprocessing and other new information about bronchoscope medical device adverse event reports.

Servicing Legislation

Biden Signs Executive Order Regarding Right to Repair

President Joe Biden signed a wide-ranging executive order on Friday, July 9, to “promote competition in the American economy.” But will such liberties be applied to the medical device sector?

FDA Updates

FDA Clears Fujifilm’s Endosurgical Image Enhancement Technology for Eluxeo Surgical System

FDA has granted 510(k) clearance for Fujifilm’s new image enhancement technology, the Oxygen Saturation Endoscopic Imaging System, which was developed to improve visualization during gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.

Government Regulations

Survey: Patients Want Better Access to, Ownership of Health Data

Axway is releasing results from a consumer survey showing that, while many Americans are taking advantage of growing interoperability in healthcare, they still want more control of their health data.

Cybersecurity

FDA Wants to Require Timely Updates, Patches for Legacy Devices: Cyber Chief

The U.S. FDA's first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency's regulatory policy can help improve it.