Mark Carlson, St. Jude Medical’s chief medical officer, explains how the CardioMEMS HF System might evolve and shares his vision for the future of epidemic disease care.

Heart failure patients used to be stuck in the intensive care unit so physicians could manage their condition. But thanks to the CardioMEMS HF System, which uses an implantable wireless sensor and external transmitter to measure pulmonary artery pressure and send it to physicians remotely, they can now be effectively monitored in the comfort of their own homes.

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October 15th, 2014
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By John Pennett and Joseph DiFalco

2014 has seen a surge in medtech companies going public. EP Vantage has reported "a frenzy for device company IPOs" with seven firms going public in April 2014 alone - almost as many the 12 firms that went public in all of 2013.  
 
Once a small medtech company has determined that an IPO is the right strategy, the road ahead might seem uncertain and overwhelming. Up until now, internal efforts were most likely focused on developing a viable product, business strategy, etc. Developing...
October 14th, 2014
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By Rich Quatrocchi

With organizations and bipartisan politicians lobbying for changes and improvements to HIPAA to accommodate mobile apps and technologies it's important to address just how much of an impact that HIPAA-compliant mobile apps can have, particularly in the role of patient engagement.

Now, more than ever, hospitals are under pressure to improve patient outcomes and reduce readmissions. With billions of dollars on the line, patient engagement plays a key role to lowering costs.
 
Medical contact centers combined with mobile applications are positioned to revolutionize post surgical follow up. HIPAA-...
October 13th, 2014
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By David P. Mierswa 

 

The healthcare Industry is facing many legal issues that not only affect healthcare workers, but patients as well. “Obamacare,” also known as the Patient Protection and Affordable Care Act (PPACA), has been the central topic within the healthcare industry for many years now. The constitutional and implementation issues are among some of the most challenging. In the wake of the PPACA, healthcare providers are facing major compliance issues and cost in the millions. However, putting aside the PPACA, there are many other legal issues facing the healthcare industry that are just as important.

The issue of data breaches is another hot button topic facing the healthcare industry. As providers switch from paper to complete electronic systems, they...
October 13th, 2014
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Attendees at AdvaMed's 2014 Conference

One of the top medical device conferences - AdvaMed 2014 - concluded in Chicago, Wednesday and a few themes emerged around an industry that is witnessing seismic changes in what the marketplace is demanding.

Reimbursement Is The New Challenge
An executive from health insurance company Cigna succinctly encapsulated the mood of the medtech industry when it comes to reimbursement.

"The enemy used to be the FDA and now I hear it's us," said Scott Josephs, MD and VP, National Medical Officer, Cigna to the audience, only half joking.

In fact at AdvaMed officials kicked off the conference with the...

October 8th, 2014
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Stuart Karten thinks the world needs to look more like the movie Her, especially with regards to health. “Today it seems like we're obsessed with screen size, resolution, thickness, new gestures, and bendablity,” the principal of Marina del Rey, CA-based Karten Design told the audience at the 2014 USC Body Computing Conference. “Serious issues to be considered, but certainly not going to lead us to the solutions of the future.” 

In the film Her the technology behind Samantha (voiced by Scarlett Johansson)– the artificially intelligent operating system – never draws attention to itself. It simply exists, allowing Joaquin Phoenix's character to work, manage his schedule, play video games, and even fall in love without...
October 7th, 2014
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Innovative, early-stage medtech startups should consider crowdfunding as a potential source of capital and a means of demonstrating market demand to future investors.                   

                         

Crowdfunding, via the rise of such platforms as Kickstarter and Indiegogo, has become a cultural phenomenon in recent years. Entrepreneurs have leveraged the concept to finance ventures ranging from ridiculous pet projects such as The World Speed Project, which aims to collect every available VHS copy of the 1994 Keanu Reeves bus-based thriller Speed, to humanitarian efforts,...

October 1st, 2014
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 By Tom KraMer

Brainstorming is taking lots of heat lately.
 
Some suggest that “out loud” brainstorming favors the bold or other personalities who tend to dominate every meeting. Alternatives include brain-writing or brain-swarming, which focuses more on writing out your ideas so that extroverts cannot dominant introverts and hamper idea generation. Still others suggest that the brain doesn’t make connections in a rigid atmosphere, because there is too much pressure or politics for people to freely respond.
 
Most people are not really knocking brainstorming. What they are criticizing is the results you can pull out of brainstorming.
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October 1st, 2014
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By Jim Dickinson

If your company is among the recipients of more than 100 letters from CDRH rescinding a marketing clearance under Sec. 510(k) of the Food Drug and Cosmetic Act, you’re now arguably free to resume marketing the affected device because FDA’s letters are illegal. That’s the bottom line of a September 26 decision by the Court of Appeals for the D.C. Circuit.

In a 2-1 decision with a whiff of politics about it, the George W. Bush–appointed majority overwhelmed its Obama-appointed colleague to rule in Ivy Sports Medicine v. Burwell that FDA cannot short-circuit the statutory medical device reclassification process by rescinding a 510(k) decision in what FDA...

September 30th, 2014
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If the fanfare over the iPhone 6 has proven anything it's that Apple's customers are just as loyal and rabid as ever. Meanwhile, the last time people waited in line for hours for a Google product was...well, it hasn't ever happened.

However, in a piece for Forbes, writer Dan Munro argues that Apple's popularity won't necessarily give the company a leg up in the healthcare space—especially given how deeply Android phones have penetrated the market. While Apple may be a top selling brand, it's the only one with iOS phones. Phones that run on Google's Android OS outnumber iPhones 2-to-1 according to estimates.
 
Munro argues for three key reasons Google will win out over Apple in the healthcare space:
 
1.) Google is winning with software...
September 29th, 2014
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