Riegel v. Medtronic
Good news to medical device makers, and bad news to patients who want to sue them.
Standards & Regulatory
FDA Issues New MDDS Rule
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.
IHE PCD Connectathon - Is Your Vendor There?
The IHE North America kicked off their Connectathon yesterday. This is the second year (?) that the Patient Care Device domain (PCD) has had something to show in the Interoperability Showcase at HIMSS.
I chatted with Todd Cooper via Skype and received the following update:
As background, there are approximately 390 engineers from 70 companies and 2 […]
Is Microsoft HealthVault Safe?
Many have criticized HealthVault regarding privacy and security concerns, or perceived limitations of HV as a personal health record (PHR). I suspect that HV is challenged more by the market's perception of Microsoft's long running security issues than with any actual shortcomings of that type in HV. And since HV is not a PHR, but […]
FDA Raises Bar on Medical Device Software Testing
Blog Medical Devices Today did a post last week on the FDA’s adoption of a relatively new software testing technology in the CDRH’s software forensics lab.
In the past year or so, the forensics lab, housed within the Office of Science and Engineering Laboratories, has used high-power instruments and techniques to analyze “source code” in roughly […]
Sensor Productization Challenges and Potential Solutions
Simon Aliwell, Director of the Sensors and Instrumentation Knowledge Transfer Network, National Physical Laboratory, in the UK, has a piece in the latest issue of MDT magazine. His outfit is a network of excellence supported by the UK Technology Strategy Board to develop innovation in sensing. Check out their web site here.
In his story […]
Premier Claims Safety Improvements with Medical Device Unique IDs
Premier Safety Institute sent out the September issue of their (usually) excellent Safety Share newsletter today. Here was the lead item (emphasis in original):
A major move to improve the safety of medical devices - On September 21, Congress approved a law requiring the Food and Drug Administration (FDA) to put into place a unique […]
Devices for Diabetics Improve
Business Week has an interesting story about recent advances in glucose meters and insulin delivery systems for diabetics. Many of the devices in the story aim to improve usability in various ways to improve patient compliance and outcomes. Proper control of blood glucose levels has a tremendous impact on a diabetic's health, quality of life […]
Patent Awarded for Wireless, Batteryless, Implantable Sensors
MEMS vendor Integrated Sensing Systems, Inc. (ISSYS) announced, “that the U.S Patent Office has granted a patent entitled “WirelessMEMS Capacitive Sensor for Physiologic Parameter Measurement” (US Patent No. 6,926,670) which covers the design, manufacturing, and anchoring of miniature, wireless, batteryless, implantable sensors.” (press release - pdf) The summary from the patent:
The invention comprises a […]
AAMI 2007 - Day Two, Afternoon
The IHE PCD crew presented Meeting the Challenges of Integrating the Healthcare Enterprise. Didi Davis from HIMSS, kicked things off describing the IHE organization, what the IHE does, and how they do it. The IHE takes established standards and through collaboration with interested providers and vendors results in a series of “integration profiles” that specify […]
