Computerized Medication Box Cleared via De Novo Downclassification.
The device, InRange's Electronic Medication Management System (EMMA) is a programmable device that stores and dispenses prescription medications and is intended for patient use in the home. A two-way communication software program allows the physician to manage dispensing of the stored pills remotely. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01655.html.
FDA Approves Medtronic’s Tripolar 16-Electrode Neurostimulation for the Treatment of Chronic Pain.
The device, Specify 5-6-5 surgical lead, uses the company’s extensive line of implantable neurostimulation systems, including the RestoreADVANCED and PrimeADVANCED neurostimulators. Additional information is available at http://wwwp.medtronic.com.
MDUFMA User Fee Bill may include Unique Device Identifier Language.
The provision would require a unique identification system for implantable devices (“UDI”), part of a push to establish a universal UDI coding system and regulations to improve the device recall process and generally make it easier to track individual products. Device companies are working with the FDA to develop a UDI system, but remain wary of mandates to implement the system for all of its products because of the cost of implementing an automated identification system and a lack of evidence that bar-coding translates to better patient safety. Additional information is available at www.thegraysheet.com. (paid subscription service)
Physicians Split on CMS Coverage of Renal Interventions.
Stakeholders are split as to whether Medicare should continue covering percutaneous renal artery interventions or limit coverage in order to encourage enrollment in randomized trials. Patient groups and some physicians implore CMS to continue coverage of renal angioplasty and stenting of patients in clinical trials, regardless of the coverage decisions it makes on the basis that providing stenting coverage on a limited basis encourages enrollment in clinical studies. However, other physicians have taken the position that renal stenting for renal artery stenosis has become the standard of care and should be covered under a national coverage decision, as stenting is highly favorable to end-stage renal failure and lifelong dialysis. Additional information is available at www.thegraysheet.com. (paid subscription service)