Dozens of patients claiming they were permanently injured by LASIK procedures have banded together on the Internet to exchange information and pressure FDA to take strong action against LASIK marketers.
By Jim Dickinson
What happens when an irresistible force meets an immovable object? Although logic says the two cannot exist at the same time, FDA may be about to find out, as it did in 1988, when persistent street demonstrators forced it to adopt emergency regulations slashing the review time for AIDS drugs.
This time, short of actual street demonstrations, the unreformed agency faces an equally persistent though numerically much smaller community of LASIK victims determined to force it to warn the public about an...
Medtech suppliers are the innovation engine that drives the overall medical device market worldwide.
To recognize that, UBM Canon invites MD&M West exhibitors - based in the U.S. and Canada - to participate in the Supplier Innovation Challenge, a contest that will acknowledge the most innovative products, services, and technologies developed in recent years by exhibitors.
Do you offer a breakthrough antimicrobial coating that could dramatically reduce instances of hospital-acquired infections, for example? Or have you pushed the boundaries of...
The medical device tax is being collected over the past two years, but with solid Republican control in Congress, talks of a repeal has heated up.
Some are predicting that it will be struck down as early as March although it's unclear whether President Obama will veto the repeal.
Others, however, don't think the tax is going away.
"I think it’s a lot of happy talk," said Brent Ahrens, seasoned life sciences VC with Canaan Partners, in an interview at the JPMorgan Healthcare Conference in San Francisco, Tuesday. "And at the end of the day, our companies have said, 'It is what it is. It’s a change in the ecosystem, it’s the cost of doing business, what...
Bioresorbable polymers are enabling the development of an increasing number of next-generation medical devices that benefit from the materials' ability to perform a specific function and then dissolve safely in the body. But the potential applications for bioresorbable and biodegradable polymers have been limited, to some extent, by the inherent properties of PLA and PGA, the most commonly used bioresorbable polymers.
Secant Medical is hoping to help push the boundaries of bioresorbable polymers, however, with the introduction of its Regenerez bioresorbable elastomer.
"[Regenerez] is very tough, elastic, elongates. This is a big differentiator," notes Brian Coffin, business development engineer at Secant Medical. "It's a bioresorbable that's elastomeric in nature instead of very stiff and tough like the PGAs and PLAs that have been in the market...
Talk of medical device tax repeal is back in circulation.
What was a bitter pill in 2013 and 2014 that the industry had largely swallowed is now on the front burner given that Congress is now firmly under Republican control. A bipartisan bill in support of the repeal has been introduced in the House and some predict the 2.3% medical device tax can be repealed by March.
The question is how much overall damage has the device tax done? And what is the true tax burden? Numbers like $20 billion and $30 billion in taxes collected over a decade are getting thrown around a fair bit in media coverage, so it's a question worth asking.
Industry proponents and critics of the tax have loudly proclaimed...
Corporate turnaround stories are not that common. Boston Scientific is an exception.
The Natick, Massachusetts company's new management has been hard at work to reverse its fortunes and modify the impression of it as a medtech has-been. Like a phoenix rising from its own ashes, Boston Scientific is well poised to make that ascent in 2015 and beyond.
Wall Street analysts presenting their thoughts on the future of the device market and the outlook for individual companies all point to Boston Scientific as one that will most likely win this year. The company also won upgrades recently from two.
Take Danielle Antalffy, an analyst with healthcare investment Leerink Partners.
Older consumers represent a lucrative market for digital health—if companies can get them to adopt their technology.
With the population of Americans over the age of 65 expected to soar to 19 million by 2050—more than tripling since 2010—makers of digital health technology are homing in on this potentially lucrative demographic.
Digital technologies promise to help older people age at home, hopefully more comfortably than generations past. But there’s one problem: Getting older consumers to adopt digital health solutions.
Venture capitalist Wainwright Fishburn Jr. says there will be three phases in the digital health revolution: monitoring, organizing and analyzing, and acting.
Fishburn explained that there will be three phases in the digital health revolution: monitoring, organizing and analyzing, and acting.
We’re already past the monitoring phase, which saw the rise of sensors and wearable devices for tracking health metrics. Pioneers of that era included companies such as Fitbit, Jawbone,...
The secret to designing useful mobile health devices is identifying the end-user and having a clear understanding of what problem your product solves for them.
By Alexa Konstantinos
A key theme at last month’s HIMSS mHealth Summit was “engagement.” Engaging patients. Engaging healthcare providers and administration. Engaging the worried well and quantified selfers. In contrast to a few years ago when the buzz was the whiz-bang app of the day, this year was all about people. And the message was this: Your technology doesn’t matter if the intended users don’t, won’t or can’t use it.
In this very human-centric approach, the profile of the end-user depends on the product, the user scenario, and the...