Dealmaking in 2009: A Look Back and A Glance Ahead
This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010.
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Device Tax, Health Reform Close To Reality As Conference Committee Meets
As the House and Senate work to meld their respective 2,000-page health care reform bills into a single politically viable plan, the device industry remains most intently focused on a mere seven pages of each: the device tax provisions
Formed by the 2009 merger of CELLective DX and DNA Repair Co., On-Q-ity Inc. is developing personalized molecular diagnostics for cancer. The start-up thinks that combining DNA repair biomarkers with its ability to capture and analyze circulating tumor cells provides a complete view of an individual patient's pending treatment options and allows for more patient-friendly monitoring of the treatment's progress. On-Q-ity is currently conducting large-scale trials analyzing the response of DNA repair mechanisms to breast cancer therapies, focusing particularly on the anthracycline class of drugs. Initial studies are based on tissue samples, but the company will begin trials with circulating tumor cells in various cancers later this year.
CDRH To Abandon Bad Precedents On Path To Predictable 510(k)s
FDA's device center wants to make the 510(k) process more predictable, but one of the first steps to accomplishing this is to break from what CDRH acknowledges are some questionable past decisions, according to a top Office of Device Evaluation official