FDA approved almost all medical devices in the last year

FDA officeThe Food and Drug Administration says it approved 98 percent of all high-risk medical devices submitted during the most recent fiscal year, the highest rate in at least 15 years. The list includes heart valves, cancer tests, gastric balloons, spinal implants and other devices used by doctors and hospitals around the country.

The 98 percent approval rate compares to 86 percent last year and 70 percent in 2012, according to recent FDA figures. It’s the highest level since at least 2001 and the first time the approval rate was in the 90s since 2005, when it was 90 percent. For the medical-device industry — including Chicago names Abbott Laboratories and Baxter International — the approvals could translate into billions of dollars worth of new revenue and profits.


About Peter Coffaro 1426 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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