Included in the social security modernization bill being reviewed by the French National Assembly is a proposal to set up specialized centers to assess innovative medical device technology and to advise the French government on its suitability for reimbursement.
The medical device industry has criticized the government for a tendency to refuse or delay reimbursement of new and expensive high-technology products such as implantable defibrillators, which are still not reimbursed in France.
SNITEM (Paris), the French medical device industry association, is hopeful that the new measure will be published as law early next year.
Voxar launches 3-D visualization software
Voxar (Edinburgh, Scotland) has developed the Plug'n View 3-D software package, which offers rapid construction of an interactive 3-D volume from computed tomography and magnetic resonance imaging studies. Image construction is typically achieved in less than 30 seconds.
This Windows- and DICOM-compliant system makes available on a desktop PC the convenience of accessing and viewing extra dimension, high-quality images. An intuitive user interface facilitates operation, said Voxar. The company's suggested hardware configuration is a Pentium P11 or P111 class processor with at least 400 MHz, a Windows NT environment, 512 MB of RAM and a 1280 x 1024 display with true color (24 or 32 bits).
Siemens optimizes U/S image visibility
Siemens (Erlangen, Germany) has developed Photopic Ultrasound Imaging as a technology that improves the visibility of ultrasound signals. Available initially on the Sonaline Elegra ultrasound platform, the technology emphasizes subtle discrepancies in tissue contrast, making lesions and vascular obstructions more noticeable.
In a clinical study with 220 cases, participating physicians said the technology aided diagnosis in 44% of all ultrasound examinations, and that it was especially useful for analyzing parenchymal organs and other low-contrast areas. Analysis of vascular examinations was improved in 77% of all cases.
The technology improves standard grayscale ultrasound imaging by taking advantage of the way humans see and recognize structures using photopic and scotopic vision (the normal ability of the eye to adjust for day and night vision). Using an image-enhancement algorithm, the system recognizes the acoustic "fingerprint" of a standard grayscale image, balances it and translates it to a color-enriched image optimized for photopic (bright light) viewing conditions. This makes it possible for clinicians to scan in normal daylight conditions instead of in a dimly lighted ultrasound examination room.
Trixell launches flat-panel X-ray detector
The Pixium 4600 large (43 cm x 43 cm) square format X-ray detector from Trixell (Moirans, France) is less than 45 mm in depth, flat panel and electronics combined. The system uses a channeled-light cesium iodide scintillator layer in conjunction with an amorphous silicon photodiode array. The system is easy to install in existing equipment, according to Trixell. High resolution and the large dynamic range of the digital image make it suitable for all types of examination.
Bone marrow density by radiogrammetry
The X-posure System from Torsana Osteoporosis Diagnostics (Vedbaek, Denmark) uses digital X-ray radiogrammetry instead of conventional dual energy X-ray absorptiometry (DEXA) for bone mineral density (BMD) estimation in osteoporosis.
Radiogrammetric measurements, which in the past have been performed manually, now can be enhanced by the application of computerized image analysis. The X-posure System, which consists of a PC, a high-resolution X-ray digitizer, printer and software package, is designed to provide a precise BMD estimate.
In contrast to DEXA, which uses absorptiometry to estimate BMD, the digital X-ray radiogrammetry (DXR-BMD) method does not use the intensity of image in a quantitative way. Instead, DXR-BMD is based on the measurement of distances on the film and can be further enhanced through automated texture analysis. This is the analysis of the microstructure in the image – for example, estimating the number and size of the pores and other structures in the bone.
In the X-posure System, the DXR-BMD value measured is corrected for striations and porosity. In traditional radiogrammetry, the structure of the bone is not included in BMD calculations. In contrast, the X-posure System automatically provides for an image texture analysis, which is included as a correction factor in the BMD calculation.
Vitamin D and osteoporosis
Vitamin D is a regulator of calcium homeostasis and bone metabolism; a deficiency of vitamin D leads to a decrease in calcium levels and to imbalances in bone mineralization. Associated with this vitamin deficiency are rachitis in children and osteoporosis in adults. Patients with vitamin D deficiency show increased excretion of collagen crosslinks, pyridinoline and deoxypyridinoline, indicative of bone resorption.
Chromsystems (Martinsried, Germany) has developed a Vitamin D3 chromatographic test kit using an isocratic HPLC system with UV detection. The company has also has launched a Crosslinks test kit that uses isocratic HPLC technology, but with fluorescence detection.
EC proposes peer review system
The European Commission has proposed a new strategy on public health that involves a six-year program to compare national health care systems among the 15 countries in the European Union. The project, budgeted to cost $320 million, will help implement the most effective policies for tackling disease and promoting health.
The program would aim to give patients in each country access to a wide range of factors affecting their health and how far public health systems meet their needs, according to David Byrne, health and consumer protection commissioner at the European Commission.
Swiss referendum approves European MRA
A mutual recognition agreement (MRA) between Switzerland and the European Union covers, among other sectors, medical devices. The agreement was approved in May by referendum and is on target to come into force by Jan. 1, 2001. The medical device MRA has already been approved by the European Parliament.
Edible vaccines on the way
Annick Mercenier and her team at Transgene (Strasbourg, France) have been investigating the possibility of using lactic acid bacteria (LAB) as candidates for use as oral vaccines and drug delivery vehicles. Their initial basic scientific research has confirmed that a number of LAB could be used as vaccine vectors. Since LAB can be taken orally, they are easy to administer. Also, since dietary LAB themselves have GRAS status (generally regarded as safe), they would be particularly useful when developing a vaccine for the young, the elderly and those with compromised immune systems.
Mercenier, who has since moved to the Institut Pasteur de Lille (Lille, France), has now completed the three-year Labvac project with a group of nine academic partners and Innogenetics (Ghent, Belgium). In this project, several strains of engineered LAB have been produced and have shown good antibody responses with tetanus toxin and Aujeszky's disease virus in pigs.
Further research is planned on using a lactic acid vector against viral infantile diseases, and on using LAB as vehicles to deliver interleukins locally.