Two studies point to the need for a more efficient, informed medical device approval process at FDA.

Jim Dickinson

Their pedigrees and their scholarship couldn’t be faulted—two deeply researched studies emerged in the dog days of August when most Washington policymakers were away, each providing potent reasons for speeding up the FDA approval process for medical devices.

The first, with no fewer than 26 authors from diverse professional settings in academia, industry, clinical practice, informatics and government, came from FDA with far-reaching recommendations to integrate existing and developing data systems and registries to “promote continuous accrual of benefit/risk and safety knowledge from invention to obsolescence.”

Entitled Recommendations for a...

September 2nd, 2015
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Despite the technology’s potential to help with everything from reducing costs to customizing devices, 3-D printing has barely scratched the surface in medtech.

Jamie Hartford

 

Still not sold on 3-D printing for medical? Today at the MEDevice San Diego conference, Derek Mathers, business development manager at Minneapolis-based product design firm Worrell Design, presented a convincing argument to make doubters change their minds.

Sales of 3-D printing machines and materials have quadrupled since 2010, with the market currently valued at $4.1 billion, Mathers said. Consumer tech giants like...

September 1st, 2015
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Pay attention to these four best practices when developing a combination product.

Arundhati Parmar

Combination products are complex by the very fact that they involve the confluence of multiple elements - drug and device; device and biologic, or biologic and drug.

That is precisely why it's imperative to follow best practices when developing these products, says David Amor, managing partner and principal at MEDgineering Inc at the MEDevice San Diego Conference and Tech Showcase Tuesday.

Here are the four that all companies developing combination products should consider:

Figure out Your Primary Mode of...

September 1st, 2015
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Medical device makers that have facilities outside the United States and use foreign suppliers are still being scrutinized by FDA. An expert weighs in on the specific challenges device manufacturers face today.

Marie Thibault

The medical device industry is becoming increasingly global, with U.S. companies gaining foreign facilities and trial sites through outsourcing, acquisitions, and geographic expansions. Suppliers from outside the United States are providing the components for medical devices cleared and sold in the United States.

But even though these facilities and suppliers are physically located far beyond the U.S. borders, FDA still has responsibility to ensure U.S. devices are safe. This means FDA has had to expand its OUS presence as well. 

What is FDA doing to...

September 1st, 2015
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Reflexion Health

San Diego-based startup Reflexion Health wants to replace physical therapy for joint-replacement patients with Vera, a digital avatar that can walk them through their rehabiliation exercises at home.
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August 31st, 2015
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Geneva Healthcare

Not every employee is trained to interpret readouts from implatable cardiac devices such as pacemakers and ICDs, so Geneva Healthcare wants to make it easy with graphical dashboards that integrate all the data they need to know.
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August 31st, 2015
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EchoPixel

Mountainvew, CA-based EchoPixel gives depth to medical imaging with its True-3D system, which allows physicians to prepare for procedures with three-dimensional images of a patient's anatomy.
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August 31st, 2015
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BioSig Technologies

Minneapolis-based BioSig Technologies wants to improve the success of ablation procedures to treat cardiac arrhythmias with its Pure EP System, which cuts out noise to improve electrophysiology recordings.

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August 31st, 2015
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T2 Biosystems

FDA cleared Lexington, MA-based T2 Biosystems's T2Candida test and T2Dx analyzer in less than four months last year, paving the way for the company to change the way sepsis is diagnosed—and save lives.
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August 31st, 2015
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Direct Flow Medical

Transcatheter Aortic Valve Replacement (TAVR) is one of the hottest technologies in medtech at the moment, and Santa Rosa, CA-based startup Direct Flow Medical is hoping to tap into the market—and take on big guys like Medtronic and Edwards Lifesciences—with its TAVR device.
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August 31st, 2015
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