News: October 02, 2007
Congress Approves FDA Reform/User Fee Bill in the Nick of Time. Last week, Congress gave its final approval to a lengthy FDA bill that strengthens product safety programs and renews device and drug user fees for five years. The bill, the FDA Amendments Act of 2007 (“the Act”), was sent to President Bush after passing with overwhelming support in both the House and Senate. The Act is strongly supported by the device industry, which helped shape the user fee reauthorization language. In addition to modifying the existing fee structure, the Act requires FDA to establish a system under which manufacturers will be required to label their devices with unique identifiers unless they receive a waiver. President Bush is expected to sign the bill before the current user fee program expires on September 30, 2007. Additional information is available at www.thegraysheet.com (paid subscription service).
CMS Outpatient Packaging Proposal Faces Resistance From Device Manufacturers. CMS has set a course for grouping hospital outpatient payments in “packages” in an effort to reign in soaring costs, but device stakeholders are urging the agency to scale back the scope and urgency of its plan. CMS proposed the expansion of “packaging” to include seven new categories of outpatient services in 2008: diagnostic radiopharmaceuticals; guidance services; imaging contrast agents; imaging processing services; intraoperative services; imaging supervision and interpretation; and observation services. The 2008 outpatient policy, effective January 1, will be finalized by CMS by November of this year. Additional information available at www.thegraysheet.com (paid subscription service).
New Quick and Cheap Bird Flu Test. Scientists in Singapore claim to have invented an inexpensive bird flu test in a hand held kit that can detect the deadly H5N1 virus in under thirty minutes. The innovation, reported in the journal Nature Medicine, relies on two technologies: a microfluid platform that manipulates a droplet from a throat swap using magnetic forces that act on paramagnetic particles, and real-time polymerase chain reaction (RT-PCT). This device potentially will enable local testing for H5N1, which is especially important in countries lacking basic public health resources. This is a crucial first step toward the successful containment of a potential global bird flu pandemic. Additional information is available at www.medicalnewstoday.com.
Medtronic Introduces Minimally Invasive System for Complex Back Surgery. Medtronic recently announced U.S. availability of the CD Horizon Longitude Multi-level Percutaneous Fixation System for use in spinal surgeries requiring multiple levels of spinal fusion. The system, which offers a minimally invasive alternative to traditional methods, consists of a free-hand inserter and reduction screw extenders. The design allows a stabilizing rod to pass through a small incision over numerous levels of spinal vertebrae. By eliminating the need for a large incision, complications such as excessive blood loss, extended recovery time, muscle damage, and large scarring may be reduced or eliminated. Additional information available at www.fdanews.com.