New CEO, 510(k) clearance at Carl Zeiss Meditec

Jena, Germany

-Ludwin Monz, PhD, MBA, is the new chief executive officer of Carl Zeiss Meditec AG, succeeding Michael Kaschke, PhD, who now is chairman and a member of the company’s supervisory board.

“I am looking forward to the new task and will continue the path the company has taken toward sustainable growth,” Dr. Monz said. “Customer-oriented innovation, excellent service, and expansion into new markets as part of our corporate RACE [Rapid Achievement of Company Excellence 2010 strategic plan] program are clearly the three most important strategic initiatives for the coming months.”

Dr. Monz joined the Carl Zeiss Group in 1994 and has worked in medical technology since 2000. In addition to various research and development positions, Dr. Monz has worked in numerous key roles within the group. He has been a member of Carl Zeiss Meditec AG’s management board since 2007 and is responsible for the largest strategic business unit, ophthalmological systems. Formerly, he led the microsurgery strategic business unit for more than 6 years. During that time, he developed the unit into a highly profitable part of the company, and numerous products were launched on the market under his leadership, according to the company.

In other news, Carl Zeiss Meditec announced that the FDA has granted a 510(k) class II clearance for its autoperimeter (Humphrey Field Analyzer II-i with Guided Progression Analysis software).

The software applies the same criteria used in the Early Manifest Glaucoma Trial in an effort to determine accurately which test points in the visual field have changed. It also uses a new visual field index to measure the overall rate of visual field progression. The software automatically summarizes all available visual field test results on a single page and calculates each patient’s rate of visual field deterioration in an effort to help eye-care providers more closely monitor vision changes to identify when a patient’s visual field loss is progressing rapidly versus when loss has been stabilized by surgical or pharmacologic intervention.

“The [proprietary autoperimeter] has been the leading perimeter in the eye-care industry for more than 25 years, and we are excited to have achieved another important milestone with the FDA’s clearance of . . . [the] software,” said Dr. Monz.