A Diagnostics & Imaging Week

Samsung Electronics (Seoul, South Korea) reported completing development of a flat-panel X-ray detector (FPXD) for radiology machines, in collaboration with Vatech, a South Korean medical machinery manufacturing company.

Samsung said that by using digital imaging with thin-film transistor (TFT) technology, “the diagnostic process is enhanced in many ways.”

It said that in addition to delivering a “much more precise image,” the new FPXD imaging sensor can save medical labs considerable time and money because no film or development process is needed.

Samsung bills itself as the world’s largest provider of thin-film transistor, liquid crystal display panels. It describes an X-ray detector as “an elaborate imaging sensor that converts invisible X-ray images into digital signals, which are then instantly transformed into pictures.”

The company said that the medical profession “still relies primarily on costly, plastic-based analog film for X-ray photography applications, which can take an excessively long period of time to develop in many medical situations.”

Executive VP Yoon Jin-hyuk, chief of the Mobile LCD Division in the Samsung Electronics LCD business, said, “The analog film camera market almost completely switched over to digital cameras within a decade. The X-ray detector market should move even faster and become completely digitized within a few years.”

The new FPXD measures 45 cm wide x 46 cm high and features a 9.4 megapixels resolution, providing ultra-high-definition images.

The new Samsung technology has what the Korean firm termed “an endless range of applications beyond conventional X-ray systems.” For example, it can be adopted for more advanced diagnostics such as CAT scans, for building inspections (scanning rebar structures) and for airport security scanners.

To create its FPXD, the company said it attached photodiodes to a TFT substrate that was produced using its proprietary amorphous silicon technology. The X-rays are detected photon by photon and then converted into visible light, which in turn is converted to electrical signals that can be displayed as diagnostic images on a flat-panel screen.

In addition, Samsung has created an image enhancement function to eliminate most digital image noise interference, “to provide the highest radiographic sensitivity in the industry,” according to the company.

The device will be available worldwide beginning in 1Q08.

Grant in-licenses molecular HPV test

Grant Life Sciences (Los Angeles) said it has signed a final agreement with Alphagenics Diaco Biotechnologies in Italy to exclusively in-license the manufacturing and marketing rights to Alphagenics’ molecular diagnostic test for human papillomaviruses (HPVs) in China and the U.S., and non-exclusively in all other countries.

The test in-licensed by Grant is a DNA-based diagnostic that uses standard molecular diagnostic equipment found in most commercial laboratories. Alphagenics’ HPV DNA test complements the HPV blood test that Grant has been developing to detect the presence of antibodies produced only by cancer-causing HPV types.

There are some 100 types of HPV, but only about seven to 15 HPV-types cause most cervical cancers, Grant said. While it said it still views a blood-based test to detect precancerous evidence and cancer of the cervix as the preferred test methodology to address the needs of the developing world, molecular testing is currently the approved test protocol in both the U.S. and Europe to identify the presence of different subtypes of HPV in the cervix.

The Alphagenics test will be able to be used in the current gynecological regimen to help qualify Pap test results in the case of ambiguous readings, at a cost less than the current approved molecular test.

Grant said it expects to launch the Alphagenics HPV DNA-based test in the Asian and Indian markets during 1Q08 as an analyte-specific reagent to reference laboratories.

biospace med closes on $18 million round

Orthopedic imaging company biospace med (Paris) has reported the closing of 112 million ($18 million) in venture capital financing, led by NBGI Ventures (London) and Cr dit Agricole Private Equity (Paris).

Edmond de Rothschild Investment Partners (Paris) and UFG PE (Paris), current investors in the company, also have subscribed to the new financing round.

The company said that Infusion of new capital from these venture funds, combined with their strong expertise in the med-tech industry, will allow the worldwide market expansion of its EOS ultra-low-dose 2-D/3-D X-ray product.

“This is a quantum leap in technology for the orthopedic and imaging communities, which have been waiting for a solution to address their specific needs,” said Marie Meynadier, president/CEO of biospace. “This new round of financing will accelerate the worldwide commercial deployment of EOS, which already is installed in several European countries and Canada.” She added: “With the recent FDA approval to market EOS in the U.S., this financing package will accelerate our market penetration there as well.”

EOS captures a whole or partial body image in a single scan without the need for any digital stitching, all using a reduced dose. The system also allows simultaneous bi-plane image acquisition (frontal and lateral).

Information submitted to the FDA in support of biospace med’s U.S. marketing application demonstrated up to 10 times reduction in dose when compared with commercially available film systems, without compromising image quality.

The company said EOS also can also generate a 3-D skeletal reconstruction from the two simultaneously acquired planar images. It said the product also will feature automatic measurement software designed to calculate a variety of length and angle calculations between individual bones and joints, “potentially helping to evaluate global balance and posture.”

EOS is based upon a patented particle detector technology for which Georges Charpak received the Nobel Prize in physics. Along with Charpak, Dr. Jean Dubousset, a noted French pediatric orthopedic surgeon, and Dr. Gabriel Kalifa, professor and chairman of radiology at Saint Vincent de Paul Hospital (Paris), assisted in the design of EOS.

Charpak founded biospace med, which has headquarters in both Paris and Atlanta, and an additional office in Montreal.

Lung Flute receives CE mark

Medical Acoustics (Buffalo, New York) said it has successfully registered its Lung Flute as a Class 1 medical device for sale in the European Union.

The company said it “demonstrated conformity with essential health and safety requirements set out in European directives,” and now is qualified to apply the CE mark for marketing the Lung Flute in the EU, for both diagnostic and therapeutic applications.

Medical Acoustics officially launched the Lung Flute within the European Union at last month’s Medica trade fair in Dusseldorf, Germany.

The company said its strategy is to penetrate the EU market through leading distributors, particularly those that serve the pharmaceutical, medical and public health markets specializing in lung and respiratory diseases.

“The Lung Flute provides EU clinicians with a safe, easy-to-use means of obtaining high quality sputum samples for the improved diagnosis and treatment of a myriad of lung and respiratory diseases,” said Terence Cryan, president of Medical Acoustics. “The applications for our device are far-ranging. They include, for example, public health officials using the Lung Flute to quickly and effectively gather sputum samples to screen for tuberculosis, or health clinics using it to clear the lungs of asthma patients.”

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