At a two-day meeting (March 16-17) to review self monitoring blood glucose (SMBG) meters, FDA officials and staff  sought input from medical experts, industry and patient advocates on ways to improve test results with the widely used devices. Approximately, 400 people attended the event, and speakers included representatives from industry, academia, regulatory bodies, and standards experts. The FDA's current standard for approving glucose meters is based on ISO 15197. This specification calls for devices to have 95% of readings be accurate to within 20% for glucose values over 75mg/dl and within 15mg/dl for readings under 75mg/dl. 

Two bone substitutes have recently made their debut in the marketplace.

One of them, called CarriGen, offers increased porosity and pore size and is the first highly porous bone-graft substitute that sets hard upon implantation, resulting in a complete fill. Manufactured by Etex Corp. (Cambridge, MA), it is a bone-void filler material that can be used in the pelvis, extremities, and spine.

“While a number of respective bone growth factors continue to populate the market landscape, none of them possess any intrinsic biomechanical characteristics, nor do they possess a biologically compatible scaffold that optimizes user handling and placement,” says Brian Ennis, Etex’s president and CEO. “Etex has devoted more than a decade of research efforts to formulate carrier technology for bone growth factors utilizing our clinically proven conductive scaffold in formats that combine easy...

The AP is reporting that Boston Scientific has suspended the sale of its defibrillators after it found a documentation error related to the manufacturing of the devices. The company is also taking all inventory of the devices that weren't made in compliance with FDA regulations. According to the Boston Business Journal, the recall could have a "material impact" on its 2010 financial guidance. "A planned process review revealed that two manufacturing process changes were not submitted for FDA approval," said Boston Scientific President and CEO Ray Elliott in a statement. “We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety. We apologize for the inconvenience these...

CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center's acceptance of the standard also includes "all collaterals and particulars," said Herman. She anticipates CDRH will publish a Federal Register notice by June 1, and from that point, there will be a three-year transition period. The third edition of IEC 60601-1 deals with the general requirements for basic safety and essential performance of medical electrical equipment.