News: July 18, 2007

House Passes Medical Device User Fee Reauthorization Bill.  The United States House of Representatives passed legislation on July 11 that includes reauthorization of the medical device user fee program.  The House approved H.R. 2900 by a vote of 403 to 16.  The legislation also contains other provisions relating to FDA oversight.  Before becoming law, the bill must be reconciled with the Senate bill (S. 1082), which was passed in May.  The device industry successfully lobbied the House for changes at the Committee level, and largely supports the House version of the bill.  The major provisions related to user fees in both the House and Senate bills adopt the FDA/industry negotiated proposal that was originally announced in April.  The negotiated bill language omits any provision for postmarket surveillance related to user fees.  However, FDA officials indicate that the agency would prefer to have discretionary allocation of its funding.  The intent of the agency would be to include use of user fees to fund postmarket safety activities.  Additional information is available at http://www.devicelink.com/mddi/archive/07/07/009.html, and at www.thegraysheet.com (paid subscription service).

CustomVue Monovision LASIK Approved.  FDA approved the first LASIK device designed to surgically correct one eye for distance vision and the other eye for near vision.  The treatment is indicated in near-sighted individuals, with or without astigmatism, aged 40 years or older with normal age-related myopia (i.e. presbyopia).  The device will correct all myopia in the dominant eye and only part in the non-dominant eye.  CustomVue uses a wavefront-guided treatment, and and eye-mapping system for laser guidance that was previously approved for myopia and astigmatism.  Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01665.html.

Implantable Spinal Cord Stimulator Launched.  Boston Scientific launched the Precision Plus implantable spinal cord stimulator for treatment of chronic pain in the back, trunk and limbs.  The device is a scaled-down iteration of the Precision stimulator that was marketed in 2005, and is the smallest rechargeable spinal cord stimulator for this indication.  The physician is able to position the leads without fluoroscopy or X-ray.  Additional information is available at www.graysheet.com (paid subscription service).

Remote Glucose Monitoring and Management.  MedApps received 510(k) clearance for its d-PAL diabetes remote monitoring system.  The d-PAL connects to Johnson & Johnson/LifeScan’s glucose monitor (One Touch Ultra) for wireless transfer of daily glucose data to a central server.  Patients may interact with the system by cell phone and can remotely answer additional questions to give other information to their doctors.  MedApps was founded in 2006, and is developing similar monitoring devices for blood pressure in congestive heart failure, breathing efficiency for respiratory diseases, tremors in Parkinson’s, as well as for use with implantable defibrillators and pacemakers.  Additional information is available at www.graysheet.com (paid subscription service).