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The Jenoptik Group (Jena, Germany) reports sales for 2007 were up 7% over 2006, delivering revenues of €520 million ($765 million) with what the company termed “a very strong contribution” from the laser and optics business, with results better than forecast.

A specialist in photonic and mechatronic technologies, Jenoptik develops and manufactures components for applications in medical technology, automotive, and the defense and aerospace industries.

The company is one of the few suppliers to produce commercial volumes of complex lasers and laser systems with the quality and process reliability required for medical applications, it said.

In early January, Jenoptik fully acquired Epigap Optoelektronik (Berlin) to reinforce its strength in medical technology, with a stated goal of capturing market share for applications home diagnostics as well as minimal-invasive surgery.

Epigap’s technology and expertise is specialized in the manufacture of selective photo diodes and LED semiconductor chips for optoelectronic components at the heart of emerging medical devices for imaging, diagnostics and interventional surgeries.

In 2007, Jenaoptik said it has reached a 1,000 unit-per-year manufacturing capacity in Jena-Göschwitz for green thin-disk lasers used for outpatient eye operations that increasingly are replacing the larger-scale lasers formerly used in this procedure.

The company said sales figures for the thin-disk lasers have climbed steadily since production began in 1999.

Green laser radiation is used to reattach the retina in the fundus of the eye, a procedure that can counter major detachment of the retina caused by old age or illness. The lasers are also used in dermatology in the treatment of skin problems, for example to obliterate varicose veins.

The green thin-disk laser is currently being developed for new applications in surgery and urology that require higher output powers, and also for analysis in biotechnology where significantly lower outputs are required.

Jenoptik Polymer Systems (JPS), another division focused on medical technologies, marked its first full year of operations in a €2.5 million ($3.65 million) facility finished in 2006 that the company says is Europe’s largest site dedicated to plastic optics product development and manufacturing.

Plastic optics are a low-cost alternative to glass optics increasingly being deployed in medical equipment, mainly in optoelectronic systems for so-called one-off diagnostics, including capsule cameras, and for in-home applications.

JPS produces customer-specified modules for that include these optics as well as image sensors, light detectors and the micro-lighting units that typically surround the lenses in medical devices.

New scandal rocks French Health Ministry

Following hard on the heels of sweeping actions taken by the French Ministry of Health to quell a national crisis of confidence in radiotherapy treatment (Medical Device Daily, Dec. 14, 2007) a new scandal involving almost 7,000 patients was revealed this month.

Five radiology centers in Normandy were at the center of a new investigation by the Health Ministry which said patients receiving routine exams were exposed to over-radiation, diagnostic errors for mammographies, and viral contaminations for both AIDS and hepatitis C.

A telephone hot line was set up to field calls from 6,791 patients believed to be at risk who will be re-examined to determine if they were victims of the negligence in radiology practice that was apparently routine at the five centers. The number of patients could be as high as 8,000, according to the regional newspaper Paris-Normandie.

The health ministry said employees at the centers revealed their concerns at the end of November, and an investigation confirmed that there were “serious disfunctions,” including unqualified staff operating radiology equipment, unqualified staff reading radiology images, failure to maintain controls and quality procedures for the equipment, and a failure to respect procedures for basic hygiene for transrectal ultrasound and endopelvic echography probes.

The centers, owned by Farid Alsaïd, MD, were closed in early December and are now running a gauntlet of investigation that includes the Inspection Générale des Affaires Sociales, the Autorité de Sureté Nucléaire and experts from the Société Fran aise de Radiologie.

Following an assessment of the risks and injuries to patients, the ministry said “complementary investigations” will determine damages owed to patients, penalties, as well as steps necessary to re-establish safe and secure radiology services for the region.

The physicians practicing at the centers have been suspended subject to a review by the regional board of physicians.

“It’s a nasty business run by insensitive doctors,” said blunt-speaking Health Minister Roselyne Bachelot, using the French word “crapuleux,” which suggests the doctors were only interested in financial gain.

CE marks for systems from ConforMIS

ConforMIS (Burlington, Massachusetts), a privately held developer of minimally invasive medical devices for the treatment of osteoarthritis and joint damage, said it received CE-mark approvals for both the iUni uni-compartmental resurfacing device and the iJig instrument system for use with the iUni.

The two products were approved separately, with those approvals allowing ConforMIS to begin sales throughout the European Union and potentially providing the basis for approval or registration in other countries outside the U.S., including Australia and Canada.

The iUni is a uni-compartmental resurfacing implant for the knee designed for patients whose arthritic damage is isolated to one of the tibiofemoral compartments of the knee, with little to no damage present in the other compartments.

The company said that as with all of its implants, each iUni is designed off an individual patient’s CT scan, using the iFit technology and made specifically for that patient. The implant is available for the medial or lateral compartments.

The surgical procedure uses patient-specific instrumentation — iJigs — that are designed off the same imaging data as the implant. The company said the iJig cutting and placement guides “significantly reduce the number of instruments required for the surgery, simplify the steps involved and increase the reproducibility of surgical results.”