MUNICH, Germany — BrainLAB (Feldkirchen, Germany) struck a nerve among orthopedic and neurosurgeons by giving them control again over radiology images with its new Digital Lightbox and has been shipping units as fast as they can be produced since the product's launch this past summer.

Last week the company reached outside of its core customer segments, offering the Digital Lightbox to gastroenterologists and general surgeons in a distribution deal it signed with Olympus Medical Systems Europa (Hamburg, Germany).

With a list price of €50,000 ($63,850) Digital Lightbox is a front-end system for a hospital picture archiving and communication system (PACS) that not only gives a surgeon access to the full set of images for each patient but also the ability to manipulate, fuse and scroll through the scans with fingertip controls.

It has been called the world's largest iPhone, as it uses a large tactile-resistive screen the size of a home cinema with fingertip controls now familiar from the best-selling mobile phone from Apple Computer (Cupertino, California).

Like the traditional radiology lightbox, the Digital Lightbox also is wall-mounted and brings surgeons back into a familiar setting for consultations and reviews of images from magnetic resonance (MRI), computer tomography (CT), positron emission tomography (PET) and X-ray, as well as all types of endoscopic images and videos.

Critically, it allows surgeons to leave the PACS workstations that they tend to dislike.

In recent years hospitals have eliminated hard copies of X-rays and other imaging modalities in favor of the paperless but powerful databases of PACS, according to Bernard Meyer, director of neurosurgery at Klinikum Rechts der Isar and chair of neurosurgery at the Technical University of Munich, who helped develop Digital Lightbox by using a prototype model.

"The problem with PACS is that they are the property of the department of radiology, and as a front-end user, surgeons do not have access to the full range of images as they did with film copies," he told Diagnostics & Imaging Week.

In the PACS workflow, radiologists select a series of images for the surgeon to view, and a surgeon often needs to become adept at the functionality of several different PACS workstations even within the same hospital.

A request to fuse the tissue characterization images from an MRI with the clear skeletal images from CT requires 10 days at Klinikum Rechts der Isar, he said.

To demonstrate his new power of control, Meyer walked to the Digital Lightbox in his office, selected a patient's file, tapped on an MRI and then a PET image, fused the two with another tap, and then by moving his finger up and down on the screen blended in and out of the respective views, which are precisely matched in three dimensions.

Total elapsed time was under one minute.

"This lightbox is connected with another one in the operating room, which physically is 800 meters from this office," he said.

"When one of my guys calls from surgery and asks me to look at something, I can see what he is doing in real time and with the same views he is looking at so we can discuss whether he should or should not do a certain thing," said Meyer.

He added that he looks forward to the day his colleagues in Berlin and Switzerland receive the Digital Lightboxes they have ordered so they can connect and consult as well.

Meyer said any two or more surgeons with the BrainLAB lightboxes can connect over secured servers and conference, though for the moment he feels like the first person who ordered a fax machine, waiting for everyone else to connect.

The sales curve for Digital Lightbox promises to follow the same, now classic curve of the fax machine's distribution until reaching a critical mass among surgeons.

Olympus said Digital Lightbox will serve as a front-end viewer for its EndoALPHA integrated endosurgery system, allowing clinicians to access and exchange information for surgical planning and collaboration.

Olympus Europe is the second-largest group within the Tokyo-based company after Japan and reported sales for 2007 of 572.5 million ($726.5 million).

Stefan Vilsmeier, the founder and CEO of BrainLAB, told D&IW the feedback for Digital Lightbox "has been absolutely phenomenal. Every neurosurgeon and subspecialists wants to have one."

He said 37 units were sold in the first three months and he is "very comfortable with the take-up."

The agreement with Olympus focuses on general surgeons and gastroenterologists, and is the first deal to move a BrainLAB product beyond what Vilsmeier called BrainLAB's "native markets," which now extend to orthopedics, neurosurgery, ear nose and throat, radiotherapies and combined magnetic field procedures.

A company spokesperson said the agreement calls for Olympus to market Digital Lightbox throughout Europe, Russia and Israel.

Concerning production of the units, the company said while the software is installed and tested at the Feldkirchen facility, BrainLAB holds an agreement with the supplier of the Lightbox hardware that guarantees a volume sufficient to meet the expected need.

New system for MRSA, other screenings

Smiths Detection (London) said it is developing a rapid diagnostic system, initially for use in hospital screening programs for infectious diseases such as MRSA and Clostridium difficile.

The company said the Bio-Seeq system will provide easy-to-use tests suitable for either a laboratory or point-of-care setting where it can be operated by non-specialist staff. Clinical trials are expected to start early next year.

The technology platform, for which Smiths Detection expects to provide a wide range of tests, is based on the Bio-Seeq portable veterinary laboratory, which is due to undergo field trials for foot & mouth disease testing with the UN Food and Agriculture Organization later this year.

Using the clinical diagnostic version of Bio-Seeq, the patient sample is introduced into a disposable Sample Preparation Unit, which is then placed on the instrument. The company said no manual sample preparation steps are needed and the unit can process a variety of solid and liquid samples making it ideally suited for combating healthcare-associated infections which kill thousands of patients each year.

A Reagent Pack, inserted into the Sample Preparation Unit, contains all the components for the specific test and includes a bar code used to set up the instrument, further reducing the operator input required. It is anticipated that Reagent Packs for a wider range of tests will be developed, either by Smiths Detection or selected development partners.

The tests will use the LATE PCR technique licensed from Brandeis University (Waltham, Massachusetts) to amplify and analyze the genetic material of the infectious agent. The power of LATE PCR will be used to detect multiple diseases in each test, and to provide clinically important information such as antibiotic resistance and genetic mutations.

Bill Mawer, head of Smiths Detection's newly formed Diagnostics business unit, said, "We are developing a powerful, flexible platform suitable for a wide variety of diagnostic tests and are keen to make that platform widely available."

Smiths Detection is seeking partners to co-develop a wide range of tests to run on the Bio-Seeq system.

NHS approves study of BT Test

Provista Life Sciences (PLS; Phoenix) said that the UK National Health Service's Ethical Committee approval has been granted to proceed with a validation study of its Biomarker Translation Test (BT Test) in the UK.

The BT Test, a new blood test developed by Provista Life Sciences to aid healthcare providers in early breast cancer detection, will undergo a validation study in the UK. The BT Test evaluates multiple cancer-related proteins in the blood and combines the results with a brief patient medical profile to help physicians in their efforts to find breast cancer as early as possible.

Clinical research conducted on the BT Test showed an accuracy rate above 80% for all women. The BT Test is designed to be used in conjunction with mammography and other diagnostic imaging procedures as part of a comprehensive breast cancer screening effort to assist healthcare providers in detecting breast cancer earlier.