News Briefs: PillCam Colon Clearance; CGM For Pediatrics; SGR Reform Bill
This article was originally published in The Gray Sheet
Given Imaging, soon to be part of Covidien, gained clearance for PillCam Colon capsule endoscopy device. FDA approves its first continuous glucose monitoring system for kids. Congress makes progress in the sustainable growth rate formula bill. More news.
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Robotic pill technology, which is already being used for diagnostic purposes, will likely be embraced for the oral delivery of biologic drugs as well. Biologic therapies currently require injections in most cases, but some are exploring specialized robotic pills as a pain-free approach that could increase convenience and compliance, and thus efficacy, of medicines. Several established companies and research centers are working on both diagnostic and biologic therapeutic applications of pill-based technologies.
Policymakers and transparency advocates at U.S. Chamber of Commerce forum March 24 pushed legislation, strategies to give patients the tools for comparison shopping different procedures.
The firm says an FDA warning letter it received cites violations based on “recent updates” to FDA’s Medical Device Reporting program made in a draft guidance last year. But FDA emphasizes that it does not take enforcement actions based on how a company implements a guidance document, draft or final.