CLINICAL IMAGING/PHOTODYNAMIC THERAPY: FDA approvals advance clinical systems

New approvals of biophotonics-based tools by the U.S. Food and Drug Administration (FDA) include Pinnacle Biologics' (Bannockburn, IL) premarket supplemental approval for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber—a light delivery system used in photodynamic therapy (PDT) with the intravenous drug Photofrin (porfimer sodium). The combination has been approved for use in treatment of non-small cell lung cancer (NSCLC) and esophageal cancer.

According to thoracic surgeon Patrick Ross, MD, Ph.D., chairman of Pinnacle's scientific advisory board, the fiber provides improved compatibility with current endoscopic equipment. This may allow use of bronchoscopes with small therapeutic channels and easier access to challenging anatomic areas. The company announced in January 2014 that it reached an agreement with the FDA under a special protocol assessment to enroll patients with an advanced form of bile duct cancer—for which there is currently no approved therapy—in a pivotal Phase 3 clinical trial.

Ophthalmic equipment developer Nidek (Fremont, CA) has received FDA approval for its RS-3000 Advance optical coherence tomography (OCT) system, which incorporates a scanning laser ophthalmoscope to evaluate the retina and choroid. The system also offers high-speed scanning of 53,000 A-scans/s during acquisition, and integrates with most electronic medical record (EMR) systems using the company's NAVIS-EX image filing software.

And finally, GE Healthcare has received clearance for its Discovery IGS 740 mobile angiography system, which is simpler to install thanks to freedom from ceiling-rail mounting. GE's goal was to "revolutionize the field of interventional imaging" by putting radiologists at the center of their procedures and enabling better access to affected areas on a patient's body. A rotating laser continuously scans the room so the system knows where it is at all times.

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