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September 10, 2015

Nipro to Acquire Infraredx

September 11, 2015—Nipro Corporation announced that it has signed a definitive agreement to acquire Infraredx, Inc. The acquisition, which is subject to certain conditions, is expected to close in October 2015.

According to the company, Nipro will combine its global cardiovascular portfolio and resources with Infraredx’s expertise in near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). Infraredx’s NIRS-IVUS imaging system is approved to detect lipid-core plaques. The agreement will help introduce Nipro’s cardiovascular product line into the United States and support Infraredx’s focus on imaging tools for interventional cardiology.

Nipro, which is headquartered in Osaka, Japan, offers products and technologies in a wide range of medical fields. Infraredx is based in Burlington, Massachusetts, and was founded in 1999 by James E. Muller, MD.

Infraredx’s multimodality TVC (true vessel characterization) imaging system is approved in both the United States and Europe for the detection of lipid-core plaques. The TVC imaging system was launched in November 2011. In March, Infraredx introduced the Advanced TVC imaging system and the Muller NIRS-IVUS catheter at ACC.15, the American College of Cardiology’s annual scientific session. The Advanced TVC imaging system is designed to rapidly, specifically, and reliably identify lipid-core plaques. The Muller NIRS-IVUS catheter features extended bandwidth IVUS technology.

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September 11, 2015

FDA Issues Draft Report for National Medical Device Evaluation System

September 11, 2015

FDA Issues Draft Report for National Medical Device Evaluation System