FDA Task Force Calls for Nanotech Guidance.  An FDA task force on nanotechnology is recommending that the agency issue guidance addressing the type of information about nanomaterials it would like to see from medical device firms and others seeking product approvals.  The report does not identify a need for new laws or regulations at this time.  However, it suggests that devices with nanoscale materials may be subjected to a higher level of scrutiny.  Most importantly, the task force recognizes that the diversity of potential uses for nanotechnology prevents the adoption of blanket restrictions.  As an outgrowth of this case-by-case approach, FDA is recommending that any firms using nanotechnology begin their communications with FDA early on in the product development phase.  Additional information is available at http://www.devicelink.com/mddi/archive/07/09/014.html.

FDA Panel to Discuss Expanding Carotid Stent Indication.  FDA will meet October 11, 2007, to discuss potential designs for a study of carotid artery stents in patients who are not at high risk for surgery.  Currently agency-approved labeling limits carotid stents to the 20 to 30% of patients who are too sick to withstand surgical endarterectomy yet need carotid interventions to clear plaque.  Physicians are making extensive use of carotid stents off-label in low-risk patients because of many patient’s preference for stenting over surgery.  As a result, physicians are having trouble enrolling patients in trials designed to compare carotid stents to surgery, such as Abbot’s stenting trial in patients at normal risk for adverse events during surgery.  Additional information is available at http://www.thegraysheet.com. (paid subscription service)

Congress Down to The Wire on FDA User Fee Reauthorization.  If Congress is unable to reconcile the House and Senate versions of the User Fee Reauthorization by September 21, 2007, FDA may be forced to lay off staff members.  However, Congress is discussing the possibility of a temporary extension of the program.  Both proposed bills would allow FDA to collect $287 million in fees from device manufacturers over the next five years and create new premarket performance goals for FDA in addition to creating a more interactive approach with industry when reviewing submissions.  The key disagreements over the bills have related to provisions regarding drug-safety monitoring and the establishment of a public drug and device clinical trial results database.  Additional information is available at http://www.thegraysheet.com. (paid subscription service)

Cardica Claims Breakthrough in Endoscopic Heart Surgery.  Two groups of surgeons recently used Cardica’s fully automated, flexible shaft C-Port Flex A anastomosis system, the only 510(k) cleared product for connecting the distal end of the graft, and Intuitive Surgical’s da Vinci robot to perform totally endoscopic cardiac bypass surgeries.  According to Cardica the introduction of robotic systems has the potential to increase the speed and reliability with which connection of the vessel graft to the coronary artery may be achieved.  NIH has expressed increasing interest in the use of these technologies and recently awarded a $5 million award to a team at Boston University to develop robotic instrument that can extend into the heart through needle-sized incisions in the chest.  Additional information is available at http://www.thegraysheet.com. (paid subscription service)

Software Systems Breaking Boundaries for Device Makers.  Recent trends in the software industry involve a growing movement by companies to create software packages capable for use across medical device categories.  For example, Omnify Software has moved from creating software which exclusively manages product life cycles to software that manages the product life cycle while also ensuring compliance with quality systems regulation.  Proponents of the new software hope that the new programs will improve device design and streamline production. Additional information is available at http://www.devicelink.com/mddi/archive/07/09/017.html.