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Minnesota pushes for faster device review | MassDevice.com On Call

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MassDevice On Call

MASSDEVICE ON CALL — Minnesota legislators penned a letter to FDA head Margaret Hamburg pushing for a faster and simpler review process for medical devices.

Sens. Amy Klobuchar (D) and Al Franken (D) were joined by Reps. Erik Paulsen (R), Betty McCollumn (D), John Kline (R) and Michelle Bachman (R) in raising concerns over "increased review times, inconsistent expectations, and poor communication from the FDA."

The North Star State is home to some of the world’s largest med-tech companies, including Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ).

The Minnesota legislators were joined by 35 other members of Congress in signing the letter, which suggested four areas for improvement in the watchdog agency’s review process:

  • Recognizing and correcting the disparity between "FDA time" versus real time when tracking device approvals
  • Considering potential benefits of harmonization with international testing standards
  • Addressing the unintended consequences of the conflict of interest rules for advisory panels
  • Creating a transparent tracking and review system for applications and clearance decisions

U.S. needs an opening to probe Olympus scandal

U.S. regulators have limited access to probe the Olympus Corp. (TYO:7733) scandal regarding concealed losses over two decades because Olympus stock isn’t traded on the U.S. exchange and the company is out of U.S. jurisdiction, Law360.com reported.

Brain stents don’t prevent strokes, study says

A new study debunks the assumption that stents used to widen blood vessels in the brain can prevent strokes, the New York Times reported.

Medtronic debuts new spinal fusion products

Medtronic expands its spinal fusion product line with the T2 Altitude spine correcting and stabilizing vertebral replacement cage and the MIDLF minimally invasive surgery system that does away with surgery through a tubular retractor, Medgadget reported.

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