Radiology clearances plummet in 2007

April 25, 2007

The first quarter of this year was the slowest of any in the seven years during which DI SCAN has tracked FDA clearances. The radiology industry was able to clear just 55 devices in the first three months of 2007. Only once since the decade began has the FDA cleared fewer than 60 devices during the first quarter. That was in 2004, when radiological device makers earned 59 clearances.

The first quarter of this year was the slowest of any in the seven years during which DI SCAN has tracked FDA clearances. The radiology industry was able to clear just 55 devices in the first three months of 2007. Only once since the decade began has the FDA cleared fewer than 60 devices during the first quarter. That was in 2004, when radiological device makers earned 59 clearances.

This year's first quarter starkly contrasts with last year's ending, as industry and the FDA tallied 99 clearances in October through December 2006. This surge marked 2006 as a record year for 510(k) clearances with 360 compared with 2005's record of 349.

Highlights so far this year are followed by dates cleared:

  • Siemens Medical Solutions' syngo MI (molecular imaging) applications 2007A, Jan. 12

  • Cerner Pro Vision, March 27

  • Siemens' Acuson X150 Ultrasound System, March 26

  • Philips Medical Systems' Essenta DR, March 9

  • GE Healthcare's PET VCAR (Volume Computer Assisted Reading), March 23

Siemens' syngo MI applications 2007A, a display and analysis software product, is dedicated to SPECT and PET systems as well as SPECT/CT and PET/CT hybrids. Enhanced planar ancillary images achieved with the company's proprietary Pixon algorithms and Flash 3D images can improve image analysis, allow dose reduction, and cut acquisition time, according to the company. Built-in quality control reminders help users maintain camera performance.

The Cerner Pro Vision, a software-based workstation, enables primary diagnostic review, interpretation, and image distribution. It can be used in a stand-alone configuration or as part of a RIS/PACS.

Siemens compared its new Acuson X150 system to the Siemens Sonoline G40. It was reviewed by the FDA for general radiology and echocardiography applications.

GE's PET VCAR is designed for use with PET/CT to assist in diagnosis, staging, treatment planning, and monitoring of cancer therapy. The computer-assisted reading program automatically highlights and bookmarks PET-identified regions of interest based on user-defined threshold settings. The software merges multiple data sets from different exams to visualize and monitor disease progression or response to treatment, automatically propagating bookmarks from one time to another.

Philips' Essenta DR is a multifunctional digital x-ray system, designed to support routine radiographic exams, including trauma or pediatric work but not mammography. A swivel arm holds the x-ray tube and detector. Patients can stand or sit as well as lie down on a mobile x-ray table. Digital imaging relies on a flat-panel detector, but the system can also produce exposures on radiographic cassettes.