FDA Grants Class II Status For Power Morcellator Containment Systems
This article was originally published in The Gray Sheet
The agency will require 510(k) clearance for the devices, which can be used to isolate tissue removed from the uterus during morcellation. However, labeling will need to state that the systems have not been proven to reduce the risk of cancer.
You may also be interested in...
On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.
New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.
Sleep apnea treatment company ResMed Corp. will pay $39.5m to settle allegations that it violated the False Claims Act by giving free or discounted goods and services to distributors and health-care providers to encourage the use of the firm’s devices.