People In Brief
This article was originally published in The Gray Sheet
Executive Summary
Spine Wave names CFO: Carmen Diersen signs on as CFO at orthopedic start-up Spine Wave, effective Sept. 1. Diersen will resign from American Medical Systems (AMS) where she helped guide five acquisitions during her CFO tenure, including AMS' $715 mil. purchase of Laserscope in July (1"The Gray Sheet" July 24, 2006, In Brief). Prior to AMS, Diersen spent 12 years in the cardiac rhythm management and spinal surgery businesses at Medtronic. Spine Wave has raised $90 mil. in funding to date, including a Series C financing worth $36.5 mil. this year. The Conn.-based firm plans a full U.S. launch of the StaXx XD expandable vertebral body replacement device this fall. The company is also developing the NuCore injectable nucleus and the StaXx FX fracture repair system. AMS appointed Jill Burchill as interim CFO...
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People In Brief
GHTF selects new heads: FDA Office of Science & Engineering Laboratories Director Larry Kessler is appointed chair of the Global Harmonization Task Force, effective Jan. 1. For the next 18 months, Kessler will serve alongside AdvaMed's Executive VP-Technology & Regulatory Affairs Janet Trunzo in her recently announced position as GHTF vice chair to promote the convergence of global regulatory practices for the medical device industry. Since its founding in 1992, the voluntary group of medical device regulatory authorities and trade associations from the United States, Europe, Canada, Japan and Australia has issued a variety of harmonized guidances on the safety, effectiveness and quality of medical devices, promotion of technological innovation, and international trade. Kessler, who replaces outgoing GHTF Chair Georgette Lalis from the European Commission, previously headed a GHTF study group that set a standard for a unified, international system for reporting medical device adverse events and established the National Competent Authority Reporting program for regulators to share post-market information...
People In Brief
GHTF selects new heads: FDA Office of Science & Engineering Laboratories Director Larry Kessler is appointed chair of the Global Harmonization Task Force, effective Jan. 1. For the next 18 months, Kessler will serve alongside AdvaMed's Executive VP-Technology & Regulatory Affairs Janet Trunzo in her recently announced position as GHTF vice chair to promote the convergence of global regulatory practices for the medical device industry. Since its founding in 1992, the voluntary group of medical device regulatory authorities and trade associations from the United States, Europe, Canada, Japan and Australia has issued a variety of harmonized guidances on the safety, effectiveness and quality of medical devices, promotion of technological innovation, and international trade. Kessler, who replaces outgoing GHTF Chair Georgette Lalis from the European Commission, previously headed a GHTF study group that set a standard for a unified, international system for reporting medical device adverse events and established the National Competent Authority Reporting program for regulators to share post-market information...
AMS gains Laserscope
American Medical Systems announces July 20 it has completed its $715 mil. acquisition of Laserscope, complementing its TherMatrx microwave system for nonobstructive benign prostatic hyperplasia with Laserscope's Greenlight surgical laser (1"The Gray Sheet" June 12, 2006, p. 10)...