Equipment manufacturers get jump on 2005 with harvest of FDA clearances

March 7, 2005

Vendors got off to a better than usual start with the FDA this year, clearing 28 devices through the 510(k) process. This was the second highest number of devices cleared by the agency during January in six years. The month was overshadowed only by January 2003, when the industry earned 29 clearances.

Vendors got off to a better than usual start with the FDA this year, clearing 28 devices through the 510(k) process. This was the second highest number of devices cleared by the agency during January in six years. The month was overshadowed only by January 2003, when the industry earned 29 clearances.

Nine ultrasound devices passed review, as did seven image management systems. Five were cleared in radiotherapy, three in MR, two in x-ray, one in nuclear medicine, and another in optical imaging of the eye.

Buoying the 28 submissions that passed review was a premarket approval given R2 Technology for a computer-aided detection system designed for integration with Siemens' full-field digital mammography setup. The approval expanded the use of R2's ImageChecker D product to process data obtained using the Novation DR and viewed on Siemens' MammoReportPlus workstation, which itself was cleared by the FDA in January. The integrated system is expected to begin shipping soon.

One of the ultrasound systems cleared by the FDA, the MyLab5/MyLab20 by Pie Medical supports B- and M-mode, pulsed-wave Doppler, color flow mapping, and tissue enhancement imaging. The new product is optimized for obstetrics. It can be equipped with either an LCD color display or a CRT color monitor, as well as a complement of convex and linear array probes. Images are stored on a USB memory stick. Fetal biometry data acquired during obstetric examinations, however, are saved into internal memory so fetal growth can be tracked throughout a patient's prenatal examinations.

Kontron Medical received clearance to market Imagic, a general-purpose ultrasound instrument with B- and M-mode, pulsed-wave Doppler, color flow mapping, and harmonic imaging. Imagic is the first member of Kontron's Sigma 5000 family, which is based on an open and flexible platform featuring PC-based architecture and digital beamforming. The new product includes a cardiovascular package.

SonoSite has been given the green light to sell its C3 Series, a full-featured, general-purpose, software-controlled ultrasound system. The product is equipped with 2D and M-mode, as well as pulsed-wave, color, continuous-wave, and velocity Doppler. The system, which is compatible with curved or linear transducers, features an electrocardiography display and supports a three-lead ECG cable to collect data for M-mode and Doppler measurements. It is equipped to measure anatomic structures and record fetal biometry.

Among the submissions addressing image management, the FDA cleared McKesson's Rad Station release 11.0 PACS workstation. Designed for reading, distributing, and storing full-field digital mammography images, Rad Station is part of the company's integrated Horizon Radiology RIS/PACS suite.

Milwaukee-based Neurognostics, a start-up specializing in functional MRI, received the go-ahead from the FDA to start selling its MindState functional Data Acquisition Device (fDAD). The device supports the acquisition of fMRI data useful in tracking disease progression in patients with disorders of the central nervous system. It might also be useful in determining patient response to drug therapy for these disorders.

The system, compatible with 1.5T and 3T scanners, presents patients with cognitive or motor stimuli while collecting time-synchronized patient responses and MR images. The data, obtained as part of blood oxygen level-dependent functional studies, are archived for later processing.

Development of fDAD was supported in part by a small business innovative research grant from the National Institutes of Health. The grant was awarded to support the development of fMRI algorithms. Neurognostics plans to develop applications for neurodegenerative and neurodevelopmental disorders including attention-deficit/hyperactivity disorder, Alzheimer's disease, and multiple sclerosis.