10 Hot Devices We Can’t Get in the U.S.

FDA officePatients in the United States enjoy some of the best medical care in the world, but many observers worry that the country’s regulatory environment is pushing medical innovation to other shores. Whether you believe FDA oversight is too stringent, too lax, or strikes the right balance, there are numerous medical devices that have achieved CE Marking, but aren’t yet FDA approved.

Here are 10 hot medical devices that have CE Mark, but are not yet available for commercial use in the United States.

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About Peter Coffaro 1436 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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