Forget fears of a dystopian world controlled by artificial intelligence and robots. Patients are enthusiastic about the potential positives drones, robots, and other technology could bring to healthcare.

Marie Thibault

Who is worried about a future full of drones and robots? Not U.S. healthcare consumers. Turns out, we are pretty interested in taking advantage of technology-enabled healthcare and would welcome drones and robots for help in diagnosing and managing diseases.

That was one of the findings from the Deloitte 2016 Survey of U.S. Health Care Consumers. The survey asked 3751 American adults about...

September 12th, 2016
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Bringing surgeons into the product development process can save time and money for device makers. How big a role are clinicians playing in R&D?

Jeff Schell

The role of physicians in business is evolving. Many are exploring entrepreneurism and developing ideas, procedures, and products that directly serve the needs of their patients. But for many physicians, the time it takes to develop and produce new products creates barriers to bringing new concepts to market.

On a similar note, medical device companies are increasingly seeking physician input to drive innovation. Early stage collaboration with physicians can reduce the need for redevelopment, along with the time and money that comes with it. The rise of physician entrepreneurship along with...

September 9th, 2016
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With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to labeling inspection.

Warren Stacey

Despite the continual tightening of regulations around the packaging and labeling of medical devices, global device manufacturers continue to persist with traditional approaches to and infrastructure for labeling. The result is that the annual volume of medical device recalls remains consistent and the implications for cost, reputation, and—at the worse extreme—patient...

September 8th, 2016
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Football is back. In honor of the NFL season opener, we're highlighting five in-development medical technologies that are trying to make the sport safer for players.

The start of football season is an American tradition, the unofficial start of fall. While the sport is as loved as always, there is growing attention about the potential medical dangers of tackles and takedowns.

NFL, in partnership with GE, Under Armour, and the U.S. Department of Commerce's National Institutes of Standards and Technology, has put a spotlight on efforts to address brain injuries with its Head Health Challenges. Numerous...

September 8th, 2016
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X2 Biosystems

X2 Biosystems, located in Silicon Valley and Seattle, has created the Head Trax system to measure the impact of repeated hits to the head.

The system includes the X-Patch Pro sensor, worn behind the ear; the X2 Sensor Data Management (SDM) app, which allows for collection and analysis of the sensor data; and the X2 Integrated Concussion Evaluation (ICE) app for testing neurocognitive performance before and after the high-contact activity.

X2's Sports Advisory Board is packed with football greats, like Terry Bradshaw and Ray Lewis. The company was recognized earlier this...

September 8th, 2016
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Software for Sideline Imaging

Researchers at the University of Aberdeen in Scotland are focused on developing software that would walk someone through conducting the brain scan on a person with a potential TBI using portable ultrasound equipment. That software would also turn the brain scan into a 3-D brain model that could be transmitted to a remote expert for rapid diagnosis and advice. 

According to a university press release, the software is still in the earlier development stages but is being trialed on hospital patients.

The work is being funded by the Defence...

September 8th, 2016
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BlackBox Biometrics

Rochester, NY-based BlackBox Biometrics has plenty of cred when it comes to military sensors. Its Blast Gauge System sensor, focused on TBI, has been used with the U.S. Army, Special Forces, FBI, and SWAT teams, according to information on the corporate website. 

The company has transferred that technology to sports with its Linx Impact Assessment System (IAS), a thin sensor that offers immediate evaluation of contact incidents. That impact data is available to players, coaches, and families via an app and can help inform decisions...

September 8th, 2016
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BrainScope



BrainScope, headquartered in Bethesda, MD, is working to find a way to determine which patients have concussions. 

BrainScope's Ahead 200 device (pictured above) received FDA 510(k) clearance in May 2015. The device takes an electroencephalograph (EEG) reading of a patient with mild TBI. With a smartphone and a custom sensor, the handheld system is used to assess damage to the brain. According to the corporate website, the Ahead 200, as well as its predecessor, the Ahead 100, are meant for development, not commercial, purposes. Its next-gen system is...

September 8th, 2016
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Quanterix

Lexington, MA-based Quanterix has developed the Simoa platform, which performs extremely sensitive automated detection and quantification of protein biomarkers. This includes blood biomarkers related to brain injury. 

Quanterix was recognized as one of six final winners in the Head Health Challenge I, sponsored by the NFL and GE, for its efforts to speed diagnosis of mild traumatic brain injuries. 

This summer, Quanterix ...

September 8th, 2016
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What is the best way to approach the vital step of usability testing? An expert shows how device makers can understand user needs, generate usability requirements, and perform the necessary assessments.

Dean Hooper

In many organizations, iterative usability testing and sound product design has become a widespread concept to the point of being considered a tautology. The consumer product industry views it as a competitive advantage and regulated product makers are feeling pressure to comply with human factors principles during product development. Indeed, FDA, for one, is requiring many medical device producers to demonstrate product safety and usability characteristics in order to market their products. This is done through simulated use and traditional usability...

September 8th, 2016
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