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Early Europe Approvals for Medical Devices Could Fade

Faster approval times have made Europe an early market for new medical devices, with U.S. approval often following a few years later.

That could be changing as regulators in the U.S., Europe and Japan look to unify their approval processes, according to an article on investor website Seeking Alpha.

“The geographical strategy that device makers have historically relied on may change now that we’re seeing greater regulatory convergence among the three major markets for device makers,” said Debbie Wang, an analyst with Morningstar Research Inc. who wrote the article.

The bad news for device makers is that approvals could become tougher in Europe, rather than easier in the U.S., according to Wang.

In Europe, medical device makers now are required to show the risk-to-benefit ratio of their products based on clinical data.

Before, they only had to show the safety of the device at the time of implant with no effectiveness requirements.

Post-marketing registries to track patients now are mandatory in Europe, according to the story.

Wang said she expects device makers to face a longer clinical process, as well as higher development costs in Europe.

“This could lessen the incentive to head for Europe first,” she said.

Typically, device makers introduce products in Europe, followed by Food and Drug Administration approval and then a Japanese launch about three years after U.S. approval.

Wang’s piece also addressed some changes underway at the FDA.

“Much uncertainty” surrounds tightening standards for the FDA’s 510 (k) medical device clearance program for approving devices similar to those already on the market, she wrote.

Earlier this year, the FDA released a report containing more than 70 proposed changes to the program.

Some 3,000 medical device applications per year, or a majority of those submitted to the FDA, are evaluated through 510 (k).

“Considering over 85% of medical device approvals are handled through (the process), versus the more rigorous premarket approval pathway, we can see why the medical device companies are sitting on pins and needles to see how the dust settles,” Wang said.

Device Company Raises $4.7M

Minnow Medical Inc., a Laguna Hills maker of devices to treat blood vessel diseases, said it raised $4.7 million in a combination of funding and debt financing.

Minnow said it plans to use the money to pay for European clinical trials and paying off bank loans.

The company makes a catheter that uses radiofrequency heat to treat peripheral blood vessel diseases and to restore blood flow and reduce plaque.

Minnow sold $3.2 million in preferred stock and $1.5 million in convertible debt as part of the financing.

Neomed Management, a Norwegian investment firm, led the funding. Other investors included San Diego-based Christopher Weil & Co., and Olav Bergheim, a veteran healthcare investor who heads Fjord Ventures, a Laguna Hills venture capital firm.

Sybron Opens Education Center

Orange-based dental products maker Sybron Dental Specialties Inc. recently opened a continuing education center in Anaheim.

Programs are set to include a broad range of topics and trends in dentistry, such as dental implants, root canals, restorative dentistry, general dentistry and orthodontics.

Sybron said that it would be able to offer continuing education for dentists in various formats, such as lectures, video presentations, live-patient procedures, hands-on demonstrations and computer assisted self-learning.

Features include a primary surgery suite, a 50-person laboratory with an adjoining observation room, and an X-ray room equipped with various types of imaging.

UCI Medical Center Changes Name

UCI Medical Center, the University of California, Irvine’s teaching hospital in Orange, changed its main building’s name to UC Irvine Douglas Hospital.

The hospital changed the building’s name in honor of M.A. Douglas, whose estate donated $21 million to the hospital after his death in 2008 at the age of 97.

The gift allowed UCI to reach a $50 million fundraising goal for its 482,000-square-foot main hospital, which was finished in 2009 and stands next to the original UCI Medical Center.

Douglas was a local real estate developer who built and managed more than 10,000 apartments, primarily in Orange County.

Bits and Pieces

Placentia-Linda Hospital completed the first round of installing electronic medical records. The hospital said the records include things such as reporting measurable patient outcomes and full clinical documentation … Aesthetic Eye Care Institute, a Newport Beach medical practice, moved from an office on Superior Avenue to nearby Hoag Health Center … West Coast Radiology Centers in Santa Ana and Santa Ana Tustin Radiology Medical Group signed three-year deals with Indianapolis-based Zotec Partners, a medical billing company with an office in Santa Ana.

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