BBI Contributing Editor

DUSSELDORF, Germany This year's MEDICA 2002 exhibition, held here in mid-November, was the largest on record, with 3,668 exhibitors from 65 countries and 132,600 visitors, a testament to the health of the medical products industry and the diversity of products and technologies employed in healthcare. Among the new products exhibited at MEDICA were a variety of devices for remote patient monitoring, including monitoring outside the typical hospital boundaries using wireless technologies. Advances also were described for monitoring of patients within the hospital to improve the efficiency of patient management and to enhance the ability of physicians to optimize outcomes of surgical procedures, including procedures using new biotechnology-derived products.

New technologies for monitoring of glucose levels in diabetics were described at MEDICA, including a new non-invasive glucose monitoring device, addressing a market that continues to expand at double-digit rates worldwide. Additional products for point-of-care testing also were featured, allowing a wider array of tests, such as cancer marker assays, cardiac marker tests and infectious disease tests to be performed outside the central laboratory.

Molecular diagnostics attracted considerable interest, including new miniaturized devices for performing tests such as genetic screening assays that require multiple markers to be measured simultaneously. Another area that is attracting increasing attention is robotics and guidance systems for neurosurgery, along with monitoring products to help diagnose and manage patients with neurological disorders. Medical information systems, including electronic patient records and smart cards for storing patient information, are growing in importance worldwide and are proving particularly successful in the European market.

Remote monitoring, POC testing expand

The market for products and services used to manage patients with chronic disease in the home and other alternate sites has entered a rapid expansion phase in the U.S., as shown in Table 1, and is now poised to become an important new segment in Europe and other regions. Leading U.S. suppliers of home telemonitoring products and services include HomMed (Brookfield, Wisconsin), Alere Medical (Reno, Nevada), American TeleCare (Eden Prairie, Minnesota), Health Hero Network (Mountain View, California), Cybernet Medical (Ann Arbor, Michigan), LifeLink Monitoring (Bearsville, New York) and Philips Medical (Best, the Netherlands).

A number of suppliers are now addressing the home monitoring opportunity in Europe. Docobo Ltd. (Fetchum, UK) exhibited a development-stage home telemedicine system, Doc@HOME, targeted at disease management companies and health maintenance organizations. The system allows a patient's 3-lead ECG as well as body impedance to be recorded at home by simply holding the unit with both hands, and it also provides two-way communication between a caregiver in a call center and the patient. Questions can be transmitted to the unit's display and the patient can respond with yes/no answers or can enter in data from other devices such as a glucose monitor or weight scale. Physicians can access the data via a secure Internet connection. Initial target applications will be management of patients with hypertension and congestive heart failure. Trials involving a total of 220 patients began in November in Finland, Estonia, Sweden, the UK and Germany. The device already has a CE mark. Docobo plans to lease the system to users at a rate of $30 per month.

Another device intended for home monitoring, the HTM-1000 Home Medic, has been developed by Bionet (Seoul, South Korea). The Bionet unit performs 6- or 12-channel ECG, noninvasive blood pressure, whole blood glucose and body impedance tests and includes a small touch screen to activate various features. An electrochemical glucometer is built into the device that uses test strips supplied by Abbott MediSense (Bedford, Massachusetts). A scale for body weight measurement can be attached via serial port. Bionet is in the process of obtaining a CE mark for the unit, and will price it at $2,000 for sale to distributors and dealers.

Aerotel Medical Systems Ltd. (Holon, Israel) has marketed the Tele-CliniQ for about one year in 32 countries, including the U.S. The unit functions as a communicator that can be used to connect up to four medical devices to a monitoring center via a standard telephone line. Interfaces are available for a precision weight scale, a pulse oximeter, a respiratory peak flow meter, a blood glucose/beta-ketone meter, an ECG recorder and a blood pressure monitor. The device costs $350 and add-on devices cost between $200 and $700. At present, the Tele-CliniQ is mainly used in monitoring of heart failure patients. Aerotel also exhibited the HeartOne, a small, lightweight (60 gram) transtelephonic ECG event recorder that does not require lead attachment to the chest. The patient simply places two thumbs on designated electrode on the device and pushes one button to begin recording, typically when an arrhythmic event occurs. The recorded results can be transmitted from any telephone including cell phones using the GSM system. The Heartline Receiving Station is available for receiving the results transmitted by the HeartOne.

Vitaphone GmbH (Mannheim, Germany) also markets a device allowing remote measurement of ECG and transmission to a monitoring station via cellphone. The Vitaphone Herz Handy resembles a standard cell phone but has four ECG leads on the back that are placed against the patient's chest to record and store an ECG. The recorded ECG can be transmitted to the Vitaphone Service Center by pressing a single button. Vitaphone charges Euro 119 for the handset and Euro 49 per month for unlimited monitoring services. As of November, the product had been on the market in Germany for about eight months, with 500 users signed up. The Herz Handy also had been available in Switzerland for about two months, with 200 patients using the service. Vitaphone plans to expand the service into Austria.

Tapuz Medical Technology Ltd. (Fischbach, Austria) exhibited the My Telemedicine ECG device that allows a patient to transmit a real-time 12-lead ECG via cellphone, regular phone line, local area network, wide area network or Internet, and includes a belt containing the electrodes allowing easy attachment by the user. The belt is placed over the chest and attaches to the arms, and the unit provides an audible signal indicating correct lead placement. ECGs can be transmitted to a personal computer for storage and review over a standard modem connection. The device also includes an internal memory capable of storing 32 tests. Versions also are available for hospital and physician use.

Card Guard AG (Schaffhausen, Switzerland), a leading global supplier of cardiac telemonitoring products and services, with projected revenues of about $50 million for 2002 (mostly in the U.S.), has developed a new product, the CG-900P Fetal Trace, to expand into the home fetal monitoring market. The system monitors fetal heart rate by Doppler ultrasound and uterine contractions via cardiotocography, and allows entry of maternal non-invasive blood pressure, maternal weight, temperature, blood glucose, and urine albumin parameters. A fetal movement marker is also included. The data can be transmitted to a PC in the attending ob/gyn's office via a standard telephone line. The product is intended primarily for use in high-risk pregnancies (e.g., for diabetics), and helps avoid the lengthy and expensive hospital stay that is often associated with such pregnancies. Card Guard views fetal monitoring as a niche market, and launched the CG-900P last August. Trials are being conducted in Europe and Israel.

Diabetes monitoring a huge market

Monitoring of diabetes represents by far the largest market at present for home monitoring and self-testing products. As shown in Table 2, the global market for glucose meters and test strips is estimated at $3.8 billion, with almost $1.3 billion of the total attributable to Europe. A number of new products have recently been introduced in this market, and, as exemplified by development-stage devices exhibited at MEDICA, additional products using novel non-invasive technologies for glucose measurement may become important in the future.

A number of suppliers have now entered the market for whole blood glucose in vitro self-testing products in Europe. The four major global manufacturers are Roche Diagnostics (Mannheim, Germany), LifeScan/J&J (Milpitas, California), Bayer Diagnostics (Leverkusen, Germany) and Abbott MediSense. Additional suppliers in Europe include A. Menarini Diagnostics (Florence, Italy), National Diagnostic Products Pty Ltd. (Gordon, Australia), 77 Elektronika (Budapest, Hungary), MedPro GmbH (Ludersdorf, Germany), Allmedicus Co. Ltd. (Gyeonggi-do, Korea), Biochemical Systems International (Arrezo, Italy), Apex Biotechnology (Taiwan), SensLab (Leipzig, Germany) and Disetronic Medical Systems AG (Burgdorf, Switzerland), selling the FreeStyle glucose meter and test strips manufactured by TheraSense (Alameda, California).

Both A. Menarini and Disetronic have developed continuous glucose monitoring devices, competing with Medtronic MiniMed (Northridge, California) and Cygnus (Redwood City, California). The GlucoDay from Menarini features a subcutaneous glucose biosensor that monitors glucose levels in the interstitial fluid through a microdialysis membrane. The membrane isolates the sensor from compounds in the interstitial fluid that would otherwise cause fouling and degrade accuracy of the readings. The sensor can be implanted for 24 to 48 hours. Studies have shown that there is a delay of about two minutes between changes in blood glucose and changes in the sensor readings, due both to equilibration between blood and interstitial fluid as well as across the membrane. However, for its intended use, which is to store a record of blood glucose trends throughout the monitoring period to assess a diabetic's individual metabolic trends, the delay is not an issue. A single fingerstick whole blood glucose reading is used to calibrate the system. The GlucoDay was launched in January of last year and is priced at Euro 4,500. The product may augment Menarini's position in the diabetes monitoring market in Europe, where it currently holds a 6% to 7% share of the whole blood glucose monitoring market.

The Disetronic continuous glucose monitor, developed in collaboration with the University of Lubeck (Lubeck, Germany), also uses a dialysis membrane, along with an electrochemical sensor that does not require an oxygen compartment, and a pump (a modified version of the Disetronic insulin infusion pump). The membrane is contained in a cannula that is implanted subcutaneously, and a push-pull pumping process is employed wherein dialysis fluid is pumped into the cannula. Glucose in the interstitial fluid equilibrates across the membrane in the dialysis fluid, and the fluid is then pumped out of the cannula to the extracorporeal glucose sensor. There is about a 10-minute delay between changes in blood glucose and changes in sensor response. The system records six measurements per hour. Both the Menarini and Disetronic systems are intended for use in characterizing trends in a patient's glucose levels over a one- to two-day period, so that the physician can determine a protocol that will optimize a particular patient's glycemic control.

Pendragon Medical (Zurich, Switzerland) exhibited a development-stage noninvasive glucose monitor at MEDICA that uses radiowave impedance spectroscopy, operating at frequencies of 1 megahertz to 100 megahertz, to monitor changes in glucose concentration. Pendragon has found that radiowaves traveling through the arm are modulated by changes in the body's electrolyte concentration, particularly sodium concentration, which are in turn a function of glucose concentration in the blood. The sensor is a miniaturized version of a vector network analyzer, comprised of a voltage controlled oscillator and a microstrip antenna, and operates at frequencies that are modulated specifically by glucose levels, according to the company. The current beta-test version of the monitor is configured as a wristwatch unit worn on the lower forearm. An initial study of nine subjects whose glucose levels were manipulated over the range from 100 to 300 mg/dL gave acceptable correlations with the levels established by a biostator. Pendragon was formed in March 2000 and is performing clinical studies with a goal of launching the noninvasive monitor in the second half of this year.

Advances in point-of-care testing

A number of other advances were described at MEDICA in point-of-care (POC) testing, including new systems for POC cardiac marker testing, new systems for critical care POC testing, and products for measuring tumor markers in the physician's office. Rennesens GmbH (Berlin, Germany) exhibited the CardioDetect, a rapid (15-minute) test for fatty acid binding protein (h-FABP), a marker of myocardial infarction (MI) that gives an earlier indication of a heart attack than markers such as Troponin I or myoglobin. Studies described by Rennesens show that h-FABP becomes elevated within 35 minutes after a heart attack, vs. about one hour for myoglobin and up to three hours for troponin. The test is configured as a qualitative card assay requiring three drops of whole blood and has been shown to have 97% sensitivity and specificity for MI detection. As with some other cardiac marker tests, kidney disorders may affect the test results, causing an extended elevation of the readings. Rennesens is working to develop a quantitative version of the test.

77 Elektronika exhibited its POC test for prostate specific antigen, performed on the company's portable reader. The test features a strip format, and readout is performed using image analysis of the strip. The results are provided in a semi-quantitative format, classified in one of five ranges (0 to 4, 4 to 10, 10-20, 20-50 and 50-100). The test strips are priced at Euro 1.40 each, and the reader costs about Euro 700. The measurement time is only two seconds after the strip is inserted.

Another POC testing platform, the Colibri system, was introduced by Beijing Blue Cross Biotech Co. Ltd. (Beijing, China) at MEDICA. The company claims the No. 1 market position in rapid tests in China, selling 400 million test strips per year, with an estimated share of 63%. The new Colibri platform will perform a wide range of chemistry and immunochemistry tests at the point of care, with a menu of 50 tests planned. Initial tests will include a high-sensitivity CRP, D-dimer, hemoglobin A1c and urine albumin. Although the company was not yet able to quote pricing, the goal is to offer the tests at a much lower price than existing point-of-care chemistry/immunochemistry test systems.

Biognosis GmbH (Julich, Germany) displayed a prototype POC testing platform designed to perform multi-parameter testing using a cartridge format. The system uses the proprietary ABICAP (Antibody Immuno Column for Analytical Processes) technology, which provides more rapid reaction times than conventional ELISA plates and combines the advantages of affinity chromatography and immunoassay. Two versions of the ABICAP system are under development for clinical use, including one for small labs and niche markets and a second for bedside testing. The system can perform up to five different tests per cartridge. Sample types include whole blood, urine and saliva. Blood samples are collected in a capillary containing a buffer to provide automatic pre-dilution, and then loaded directly on the system. Initially, the test menu will be focused on infectious disease assays such as tetanus, diphtheria, rotavirus and adenovirus. Assays for HIV and hepatitis also are under development and Biognosis is evaluating the possibility of performing cardiac marker tests on the system. While the initial assays will be qualitative tests, it is possible to perform quantitative tests using the platform technology. Key features of the system are rapid turnaround, with most tests completed in ten minutes, and high sensitivity approaching that available on central lab analyzers.

Innotrac Diagnostics (Turku, Finland) has been marketing its Aio! POC testing system in Europe for about two years and is now planning to submit a 510(k) to enter the U.S. market. The Innotrac POC system employs time-resolved fluorescence, a highly sensitive detection technology, and cuvettes that contain all reagents needed to perform a test. The test menu includes cardiac markers (Troponin I, CK-MB and myoglobin), with high-sensitivity CRP and hCG in development. Test turnaround time is 18 minutes for one analyte or 20 minutes for a panel of three. Up to 88 samples can be loaded on the central lab version of the system. The tests are priced at five to seven Euros each, and the analyzer is priced at 30,000 Euro. The Aio! would compete in the U.S. market with the Stratus CS marketed by Dade Behring (Deerfield, Illinois) and the Triage Cardiac System from Biosite (San Diego, California). Innotrac is searching for distributors in the U.S.

Mitsubishi Kagaku Medical (Tokyo), another supplier that will enter the market for rapid POC testing systems for cardiac markers and other rapid immunoassays next year, exhibited its Pathfast system. The Pathfast, which will be introduced at next year's MEDICA exhibition with a cardiac marker panel, uses chemiluminescence detection and will provide results in 15 minutes at a cost of one Euro to eight Euro. The reader will be priced at 18,000 Euro. The system is targeted at the emergency diagnostics segment and will be designed for operation by non-laboratory personnel. Up to six patient samples can be loaded for a single analyte, or a six-test panel can be run for a single patient. The system will use whole blood samples, and will offer high sensitivity (0.1 ng per ml).

Advances in molecular testing

As in the U.S., molecular diagnostics represents a growing market in Europe. Sales in Europe are projected to account for about 37% of the global market for molecular diagnostic products in 2002. In addition to current-generation systems for molecular testing, such as the Amplicor from Roche Diagnostics, the Abbott LCx and the ProbeTec ET from BD (Franklin Lakes, New Jersey), a number of companies have described next-generation systems using microarray technologies for molecular diagnostics.

Clondiag Chip Technologies GmbH (Jena, Germany) has developed the AT Platform for applications in genomics testing, including POC and alternate site diagnostics. The company's AT Platform uses a microchip array bonded into the bottom of a standard microtube, eliminating the need to aspirate the final reaction mixture for pipetting onto the detection array. Arrays have been designed both for nucleic acid analysis as well as for proteomics analysis. A new labeling system using gold particles and silver staining allows readout of the chip at relatively low cost.

Clondiag is partnering with Bruker Daltonics GmbH (Leipzig, Germany) to commercialize the technology for clinical diagnostics. Although the Clondiag arrays can have up to 16,000 sites, the existing device has only 4,096, as that has proven sufficient so far for the applications under development by the company, which include genotyping and SNP analysis as well as immunoassay. Readout is simple and low-cost, using transmission light microscopy. The company plans to introduce a version for clinical applications in partnership with Bruker this coming spring. Because the ArrayTube AT is the same size as a standard microtube, assay processes can be automated using equipment that is already available in most labs. The tube also includes an attached cap, so that it can operate as a closed system to avoid problems with evaporation and contamination. A second configuration, the ASPIS platform, uses an Array Processor that integrates a microarray into a microfluidic PCR chamber, creating a cartridge that can be used to perform integrated amplification and detection. The ASPIS system controls parallel PCR processing of up to eight Array Processors. The system also includes a fluorescence reader module that performs rinsing, readout, and data analysis. An initial application for genotyping of the human CYP2D6 gene has been developed.

Roche Applied Science (Penzberg, Germany) exhibited its matriXarray platform for custom gene analysis, which will be available in Europe this month at a price of Euro 80,000. The matriXarray uses the CombiMatrix microarray technology acquired by Roche, which provides arrays with 1,000-spot density. Higher-density arrays with up to 10,000 spots will be available in the future. Roche provides custom chip synthesis services, primarily targeted at applications in genomics research.

Miniaturized diagnostic devices are being developed by a number of companies that will have applications in automation of molecular diagnostic tests, as well as other types of tests now performed on large laboratory analyzers. A new entrant in the lab-on-a-chip field, Digital Bio Technology (Seoul, Korea), has developed a number of miniaturized devices, including the C-Reader microchip blood cell counter, the C-Film plastic microchip hemocytometer, a microchip erythrocyte analyzer, the DBCE microchip flow capillary electrophoresis device, the ABO View point-of-care blood typing microchip, and the C-Box, a benchtop flow cytometry unit using a disposable microchip that integrates fluidics, optics and electronics onto a single miniaturized device. The C-Box micro flow cytometry system includes hydrodynamic focusing capabilities and fluorescence detection, and is priced at $25,000. Individual tests are priced at $1 each. Digital Bio also has developed a DNA chip scanner, the DCR250 Genoscope, a $13,000 (base price) system with a low-luminescence CCD camera detector, which can be used with existing DNA microarrays for assay readout.

New monitoring technologies

Advances in patient monitoring technologies were also described at the MEDICA exhibition that will allow physicians in a number of disciplines to monitor the results of treatment more effectively. For example, LEA Medizintechnik (Giessen, Germany) exhibited the O2C monitor for noninvasive determination of oxygen supply in blood-perfused tissues. The device performs laser Doppler measurements of blood flow along with measurement of oxygen saturation and relative amount of hemoglobin in blood flowing in the skin at two different depths (2 mm and 8 mm) simultaneously. A key feature of the O2C is its ability to measure blood flow, oxygen saturation and capillary filling at the venous end of the capillaries, which is the critical point for determining true oxygen supply to tissues. Applications include intra-operative and post-operative monitoring of skin grafts and deep muscle transplants, monitoring of wound healing, including chronic wounds in diabetes, and assessment of diabetic foot syndrome.

An implantable version of the probe, launched in December, can be inserted in an auxiliary drainage catheter in organ transplant patients to monitor the blood and oxygen supply to transplanted kidneys, livers, hearts and other organs. Detection of impaired flow or low oxygen delivery can allow the surgeon to re-intervene at an early stage, for example, by giving heparin to reduce clotting or by surgically modifying an anastomosis. The O2C has been on the market in Europe for about eight months, and the company plans to file a 510(k) to enter the U.S. market in mid-2003. The system is priced at Euro 40,000. Another potential application is detection of sepsis using a gastric probe.

Cardiosonix (Ra'anana, Israel) exhibited the Quantix/OR vascular Doppler device for intraoperative blood flow measurement. The non-invasive device has applications in cardiac surgery for evaluating the quality of the anastomosis in bypass procedures, in vascular surgery and monitoring of organ perfusion during surgical procedures. It uses angle-independent ultrasound technology to quantify blood flow in a few seconds and does not require manipulation of the blood vessel as do certain alternative techniques. The system is priced at Euro 20,000 to Euro 25,000, depending on options.

Another noninvasive product, the Bytec device from Wilddesign (Gelsenkirchen, Germany), can be used to detect intracerebral hemorrhages by measuring diffusely scattered laser light. It is designed primarily for use in remote or rural areas where sophisticated imaging equipment may not be available.

VSM MedTech (Vancouver, British Columbia) is developing a device for non-invasive monitoring of arterial blood pressure that may revolutionize pressure monitoring in the operating room, intensive care unit and emergency department. The VSM monitor employs optical sensing of the transit time for blood pressure pulses between two sites, one on the patient's earlobe and a second on the fingertip. The pulse transit time can be related to changes in elasticity of the arterial wall, which are in turn related to changes in blood pressure. The system is calibrated when first attached to the patient using a standard blood pressure cuff measurement, and subsequently tracks changes in blood pressure on a beat-to-beat basis. Conventional noninvasive blood pressure monitors can only provide a reading every three to five minutes and can cause some arterial trauma to the patient. Invasive monitors using an indwelling catheter to measure continuous blood pressure are considerably more expensive and pose risks of trauma and infection. As a result, only 5% to 10% of patients in the OR, ICU or ER receive invasive pressure monitoring, in spite of its ability to provide much more informative data on patient status and response to vasoactive drugs as compared to conventional non-invasive blood pressure monitoring. The VSM device will potentially provide data that is equivalent to invasive pressure monitoring non-invasively and at considerably lower cost. VSM quotes estimates of the potential market for a continuous noninvasive blood pressure monitoring device at $1 billion to $2 billion. The company estimates that the disposable components for the optical monitor will sell for $10 to $12 per set. VSM plans to commercialize the product through a partner with an established position in the patient monitoring market, such as a supplier of pulse oximetry products. A U.S. patent was allowed on the CNIBP technology last October.

Neurological monitoring advances

Advances in neurological monitoring, including new technologies for guidance of neurosurgery procedures, also were described at MEDICA. The U.S market for neurological monitoring products exceeded $150 million in 2001, and is expected to exhibit moderate growth over the next five years. The worldwide market is at least twice the size of the U.S. market. VSM also is participating in the neurological monitoring/diagnostics segment with the Omega magnetoencephalography (MEG) functional mapping system, manufactured by the company's CTF Systems subsidiary. The Omega system provides whole cortex mapping of brain function, with one millisecond temporal resolution and 1.4 mm spatial resolution. It can be used for real-time monitoring during brain surgery and also has applications in evaluation of patients prior to undergoing surgery to treat epilepsy, as well as for intraoperative monitoring of such procedures. The Omega system is priced at $1.3 million to $2 million, and reimbursement for MEG monitoring is available in the U.S. VSM has a 66% worldwide market share, according to the company, with Neuromag (Helsinki, Finland) accounting for the remainder.

Another important segment of the neurological monitoring market is level-of-consciousness monitoring. Aspect Medical Systems (Newton, Massachusetts) is the leading supplier of level-of-consciousness monitoring products, with a worldwide installed base of 15,500 BIS monitors at the end of 3Q02 and installations in about 27% of all operating rooms in the U.S.

Danmeter A/S (Odense, Denmark) supplies a competing monitor, the AAi, that uses auditory evoked potential rather than passive EEG monitoring to determine the level of consciousness for patients undergoing anesthesia. The device emits an audible click and measures the EEG response using a 3-electrode sensor. The monitor is priced at $10,000 to $12,000 and has FDA clearance, but has not yet been actively marketed in the U.S., with most placements in Europe.

Eldith GmbH (Ilmenau, Germany) introduced a new system that combines EEG monitoring with patient feedback for the treatment of epilepsy. The company received its initial round of venture funding in May and has developed two products, Neuro Prax and Neuro Home. Neuro Prax incorporates a 32-channel DC EEG amplifier that allows recording of very slow potentials and that also includes proprietary software for analyzing the signals and displaying information that the patient uses to modify his or her neurological patterns. Studies have shown that 70% of epileptic patients can use the feedback technique to avoid seizures. About 50% of epileptics are refractive to drug therapy, and the Eldith technology can be used by those patients as an alternative to control their seizures. Even patients who are responsive to drug treatment can benefit from the system by allowing a reduced dosage of drugs to be used to control their epileptic seizures. The Eldith system, which was launched at MEDICA, is priced at Euro 35,000.

Medtronic Surgical Navigation Technologies (Louisville, Colorado) described new developments in surgical guidance technology with primary applications in neurosurgery. The company has established a partnership with Odin Medical Technologies (Newton, Massachusetts) to integrate the Odin PoleStar open MRI system with its StealthStation Treon surgical navigation system. More than 1,000 StealthStation systems have been installed worldwide, and 14 PoleStar 0.17 Tesla PoleStar systems have been installed. Both systems are FDA-cleared. Under an exclusive agreement signed in April of last year, Medtronic Surgical Navigation and Odin are developing a system that allows data from intra-operative MRI scans to be combined with the guidance information provided by Treon, and which provides a visual reconstruction of the target combined with electronic guidance information for the surgeon.

The PoleStar design confines the magnetic field to a region between the magnet poles and its immediate vicinity and avoids the need to rebuild the operating room in order to accommodate the installation. During a procedure, the MR assembly can be moved into place for a scan whenever needed, and the MR image data is automatically transferred to the Treon navigation system. The MR assembly is then removed, allowing the procedure to proceed under electronic guidance, without the need for all instruments to be MR-compatible. The design minimizes the number of instruments and devices in the OR that must be MRI-compatible. In addition, it provides the advantages of intra-operative MR guidance, resolving issues with shifts in position of brain structures during a procedure.