Fewer doctors today than in 2012 believe that EMRs actually help to improve treatment decisions, reduce medical errors and improve patient outcome. 

Arundhati Parmar

The annual conference of Healthcare Information and Management Systems Society (HIMSS) kicked off Sunday in Chicago, but already there is some sobering news about the value of health IT in medicine.

A new survey conducted by consulting firm Accenture found that while more doctors are using electronic medical records than two years ago, fewer believe that EMR use has improved treatment decisions, reduced medical errors...

April 13th, 2015
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From powered exoskeletons to drones that deliver medical supplies, robots are increasingly making their way into medicine.

Robots have already revolutionized medical device manufacturing, but now they're coming out of the factory and into the clinic. 

Valued at $1.8 billion in 2013, the market for medical robotic systems is expected to more than double, to $3.8 billion, by 2018, according to market research firm MarketsandMarkets. And although surgical robotics date back to the 1980s, robots today are being used for everything from disaster response to diagnosis.

This infographic from Worrell, a product design,...

April 12th, 2015
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An analyst writes that St. Jude Medical's novel implantable heart failure monitoring system may overwhelm some medical centers not equipped to manage influx of data.

 Arundhati Parmar

The CardioMEMS sensor is implanted on the pulmonary artery to monitor CHF patients remotely.

 

St Jude Medical's CardioMEMS implantable device system that monitors the condition of congestive heart failure patients remotely is by all admission a novel technology.

In a clinical trial with 550 patients, the CardioMEMS device implanted on the pulmonary artery showed a 28% reduction in heart failure hospitalizations at six months, and a...

April 10th, 2015
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Direct Flow Medical, which has developed a metal-free TAVR product, is taking on Medtronic in a bid to prove that its TAVR technology is better. 

Direct Flow Medica's TAVR product is going head-to-head with Medtronic's CoreValve

Arundhati Parmar

Many covet a piece of the pie in transcatheter aortic valve replacement for patients with severe aortic stenosis. The technology is proving to have good clinical outcomes compared with the more invasive open heart surgical procedure to repair or replace diseased aortic heart valves.

Edwards Lifesciences and Medtronic are two companies with approved devices in the United States,...

April 9th, 2015
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Turning data into simple numbers can lead to disastrous results.

Stephen B. Wilcox, Ph.D., FIDSA

In many, many fields, the transition from a largely qualitative or intuitive basis for understanding (and prediction) to a quantitative basis for understanding has been extremely productive. Fields as diverse as bridge design, animal breeding, baseball, and, yes, human factors, attest to the power of quantitative approaches.

Quantitative methods replace nonquantitative methods through a relentless process of survival of the fittest. For example, as described in Michael Lewis’ entertaining book Moneyball, the baseball teams that continue to rely on old-school scouts who use their experience and intuition to spot hot prospects have been consistently bested by the ones who’ve hired a new generation of statisticians who’ve developed predictive models based on a version of big data.

Thus, it’s no surprise that...

April 8th, 2015
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Arundhati Parmar

New technology use and adoption is often correlated with youth.

And yet, that focus on youth may be misplaced given that the United States has an aging population. By 2030, there will be about 72.1 million people who are 65 and older. That is more than twice their number in 2000, according to the Administration on Aging. In 2000, the 65-plus crowd represented 12.4% of the population, but is expected to grow to be 19% of the population by 2030. 

So knowing how technology works for older Americans, especially as it relates to health and wellness, is important. A new project aims to fill in some of the gaps in this respect. The American Association of Retired Persons (AARP) ...

April 7th, 2015
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Medtronic has just bought a Dutch clinic and research center focused on diabetes management. Can the company still be called just a device maker?

Arundhati Parmar

A fundamental transformation is underway at Medtronic.

Terms like continuum of care, disease management, population management and integrated care that would have been absent from its lexicon even five years ago  are popping up in presentations by its CEO, in its communication to investors and analysts and yes, in rationales for doing business.

Most recently this was observed in its acquisition of a Dutch diabetes clinic and research center for an undisclosed amount. Medtronic...

April 3rd, 2015
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Until developers of wearable devices get the user experience down pat, the technology will struggle to gain adoption.

Steve McPhilliamy

The Near&Dear wearable device allows remote monitoring by caregivers.

The growing trend of personalized medicine and a movement toward performance-based health outcomes are both responsible for driving significant market demand for wearable technology. However, while wearable sensors and backend analytics are evolving to support these trends, the user adoption puzzle has yet to be solved.

A range of core user-interaction issues persist, preventing companies from...

April 2nd, 2015
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Sonitus Medical raised $80 million from investors including Arboretum Ventures, Aberdare Ventures, and Medtronic, but a negative Medicare coverage decision shuttered the company.

Arundhati Parmar

It's not often that you hear that a startup that raised $80 million from well-known investors, is revenue generating and whose technology has been hailed by the Cleveland Clinic has shut down.

And yet that is the story of California startup Sonitus Medical.

It developed the SoundBite Hearing System system that it billed as the world's first "removable bone conduction hearing device that transmits sound via the teeth." FDA cleared the product for patients who...

April 2nd, 2015
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FDA uses a warning letter to publicize its anti-leasing policy, but is the policy enforceable?

Jim Dickinson


Every now and again, Center for Devices and Radiological Health (CDRH) flexes regulatory muscles it doesn’t have.

There was the time when it lost a federal court case against Utah Medical Products in 2006 over its unsustainable contention that a new good manufacturing practice becomes a regulatory requirement when it's generally accepted by industry, even if not written down and even if a majority of firms do not follow it.

That was blown out of the water by the presiding judge, who observed that in regulatory oversight of compliant companies, “many roads lead to Rome.” The government chose not to appeal, although CDRH wanted to...

April 2nd, 2015
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