Feds Reopen Probe into Medical Scanners

Did you think it was over? Well, the feds thought otherwise. Federal inspectors are again looking into allegations by FDA scientists that they were pressured to approve medical devices that were potentially harmful to patients. Such devices include CT scanners and other imaging devices that use radiation to treat or detect diseases. A lead inspector told the Associated Press that the case is being revisited to investigate manager misconduct.

 

"The original intent of the investigation was to look at criminal matters and our agents did that," said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. "But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective."

 

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September 30th, 2010
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North American EBCIs Rebound

NEMA's electroindustry business confidence index (EBCI) for the North American sector rose 7.3 points in September to 52.6. (A reading over 50 indicates that the majority of panelists reported improved conditions.) The index for future North American conditions increased 12.1 points to 66.1, which is a decent sign after three consecutive months of declines. Take a look at the full report here.
 

 

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September 29th, 2010
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DesignMED conference tracks are live!

The DesignMED conference is aimed at designers of medical electronics. The program features a combination of technology professionals and industry's leading experts. The conference takes place February 8-10, 2011 in Anaheim, Ca.

The conference portion of DesignMED will start off with a Keynote Address (check back soon as we’re still finalizing the speaker). That will be followed by about 30 technical classes, broken into roughly six tracks. Those tracks are:

  • Imaging
  • Diagnostics and Monitoring
  • Implantable Devices
  • Personal and Home Healthcare
  • Wireless/Networking
  • HCI (Human-Computer Interfaces)
  • Device Safety and Security

Attendees will hear practical information and innovative solutions they require to take their products from concept to market.

In addition to the classes, the exhibit floor will be stocked with vendors with products designed specifically for medical electronics. They...

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September 24th, 2010
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Medical class at ESC Boston

I sat in on a class yesterday at the Embedded Systems Conference in Boston. The class was given by IBM, and it talked about the validation of medical device software using model-driven development (MDD).

While I thought the class was taught at a level that was too high for the technical audience, there were some good ideas/concepts discussed. For example, the instructor talked about the five forces that affect the medical community:

  • Legal
  • Markets and financial
  • Technology
  • Regulations
  • New product development

I hadn’t seen such a concise list like this one, but it’s a nice way to break down the various components of the medical industry. In this space, we generally discuss the technology, but each of the other four topics has a direct impact on the technology. If there are issues in any of the five topics, the road to product launch can be long and...

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September 23rd, 2010
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ESC Boston helps gauge the embedded community’s interest in medical

With the Embedded Systems Conference coming up next week in Boston, it’ll give me an opportunity to gauge the interest of the embedded guys in the medical space. They all tell me that they’re very interested, but now we can have some real discussions to see what their real plans are.

The keynote address is being delivered by Hugh Herr, a walking billboard (literally) for medical-electronics technology. If you’re not familiar with Herr, he lost both of his legs in a winter mountain-climbing expedition. He vowed to develop a technology that will not only get him back to where he was, but to improve upon his “old” legs. Amazingly, he has succeeded.

I’ll be meeting with the RTOS vendors, the processor/MCU guys, and some of the board makers over the next few days. Check back to find out of their interest is real...

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September 17th, 2010
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Reimbursement May Get Quicker

Makers of electronic medical devices jump through several hurdles to get their product on the market, and sometimes an even bigger hurdle is reimbursement. In what can only be seen as good news, FDA and CMS announced plans to review devices together. Private insurers often look to CMS's coverage policies before crafting their own. In addition, a positive decision from Medicare can speed a device's acceptance in the marketplace.

Send comments to the agencies by December 16. Click here for more information.

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September 17th, 2010
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Eurotech to Supply Embedded Components for Diagnostic Devices

Embedded technologies supplier Eurotech (Columbia, MD) has signed a $1.5 million contract to supply embedded computers to a medical OEM that specializes in diagnostics and information technologies. The six-month contract involves the supply of chemistry analyzers with the Eurotech Sphere II single-board computer, which extends the life cycle of these products using ARM technology. The devices are used to test for diseases in minutes and connect to a laboratory information management system that collects all results into an electronic medical record.
 

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September 16th, 2010
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Medical Imaging for the EVO

The iPhone isn't the only smartphone with relevance in the medical device world—or at least that's what Sprint is hoping. The carrier has partnered with Calgary Scientific to develop an imaging tool that the companies say could help improve patient outcomes, treatment decisions, and the cost for long-term patient care.
 
ResolutionMD Mobile is designed to offer physicians advanced visualization of medical images on their HTC EVOs (disclosure here—I have an EVO and I'm in love with it). The program is HIPAA compliant and Calgary is seeking FDA approval for certain diagnostic elements of it.
 
“As our nation’s population ages, and the number of people with acute care requirements and chronic illnesses continue to grow, mobile...

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September 15th, 2010
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What a surprise: A medical electronics conference

I spent many hours over the past few years creating technical conferences for design engineers. In my previous life, it was the Embedded Systems Conference (ESC), a highly successful conference aimed at software and hardware developers putting together the latest embedded systems for a variety of applications. Many of you should be familiar with ESC, as in the last couple of years, there was a fairly detailed medical design track.

Now that I’m full immersed in the medical space, I’m working on a conference on medical electronics. Called DesignMED, the conference will focus on all aspects of designing the electronics portion of a medical device. That “device” could range from something small, light, and battery-powered like a glucose monitor, up to something big, heavy and expensive, like an MRI machine.

While many of the challenges of designing those devices are varied, many of...

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September 10th, 2010
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Back to blogging about electronics (the medical kind)

I’ve been blogging about medical issues lately, but mostly as they relate to medical electronics. I’ve been posting those blogs on our sister site, Medical Device and Diagnostic Industry, aka MD+DI, but they really belong here on MED, the acronym we use for Medical Electronics Design.

The issues associated with medical electronics and embedded systems, which I’ve been writing about for many years have a lot of similarities. Like medical, the priority list for many embedded systems includes performance, security, availability of components, etc. While cost is on the list, it’s generally not at the top of the list. Those medical devices (at least the kind that house electronics) typically contain a processor, an operating system, lots of analog and digital circuitry, and so on.

So the bottom line is that I’ll be contributing and blogging regularly in this space about issues related to medical...

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September 9th, 2010
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