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Looking for answers? Start your search in our DesignMED resources. The DesignMED resources pages are populated with whitepapers, tutorials, datasheets, etc., all related to the design of medical electronics devices. Click here to find information necessary to avoid the pitfalls associated with medical system design. Areas covered include board design and layout, IC selection and placement, software architectures, operating systems, and much more.
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People often think of a battery as an energy-storage device that’s similar to a fuel tank dispensing liquid fuel. For simplicity reasons, this is somewhat accurate. However, measuring stored energy from an electrochemical device is far more complex. The battery fuel gauge is generally poorly understood, particularly in the medical field.
While an ordinary fuel gauge measures liquid flow...
FDA today released draft guidance for artificial pancreas device systems for treatment of type 1 diabetes, an event one advocacy group is hailing as a “huge opportunity for patients.”
A press release issued by FDA says the draft guidance provides “flexible recommendations for design and testing” of the systems—including leeway in the choice of clinical study length...
Insulin pump with infusion set. Photo by Mbbradford at en.wikipedia [Public domain], from Wikimedia Commons.
FDA today received a petition urging the administration to issue “clear and reasonable” gui dance for development of an artificial pancreas.
More than 100,000 people throughout the United States signed the petition, which was launched by the Juvenile Diabetes...
When the third edition of IEC60601-1 was published, it marked the beginning of a new era. The standard now incorporates the concept and application of risk management in the design and production of devices. Implementation of risk management has implications for not only the end-product manufacturer but component providers as well, and further cascades through the entire supply chain. All parties...
Last week, we brought you a feature on new reliability tests in line with RoHS. Little did we know how timely it would be. India recently became the latest country to enact such legislation, as our sister site EBN reports.
RoHS legislation has also been enacted in the EU, Japan, China, Korea, and California. Ken Manchen, of Newark/element14, wonders which country will be next:
Will it be...
The first Restriction of Hazardous Substance (RoHS) legislation out of Europe, in 2006, provided an exemption for medical electronics. However, a second version that modifies this exemption has been released. Medical devices will be covered as of 2014, in vitro diagnostic equipment as of 2016, and industrial monitoring and control instruments as of 2017. The importance of planning for lead-free...
Wind River is the next major operating system (OS) vendor to understand the value of having an enriched medical offering. The company recently introduced a platform for medical devices, which is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, FDA 510(k), or the more stringent Premarket Approval.
The...
The newly upgraded intrinsically safe Earth-Rite TELLUS II from Newson Gale offers effective, constantly verified static ground monitoring for drums, IBCs, and other mobile or portable equipment during hazardous area operations. It’s suitable for use in the handling, transporting, or mixing of combustible products. The TELLUS II provides the operator with a bright green flashing LED to...
Medical devices have to be reliable—people's lives depend on them. But current reliability testing standards don't cover all of the specific stresses faced by implantable medical electronics products, including implantable subcutaneous glucose monitors and retinal implants. Now, one industry organization is trying to change that.
The International Electronics Manufacturing...
Bluetooth low energy is an important wireless medium for the medical space. We’ve covered it lately and readers have told us how critical it is. Texas Instruments (TI), one of the innovators in wireless technologies, recently launched ten Bluetooth low energy technology (Bluetooth v4.0) profiles with associated sample applications for compliant sensor devices.
The Bluetooth low energy...
Medical developers must think differently
The biggest difference between a mainstream embedded application and a medical application is that the medical device usually has to work right all the time, every time. For the majority of embedded applications, it a product has an infrequent error or needs a reboot, it’s a nuisance, but not much more than that. For medical applications, product...
Anytime FDA starts proposing new regulations for medical devices, designers understandably get wary. But according to experts, the administration’s proposed regulations for medical mobile apps might result in more clarity than confusion.
According to the draft guidance issued last week, FDA is proposing to regulate apps that “are used as an accessory to a medical device already...
As promised, FDA has issued draft guidance laying out plans for the oversight of mobile applications used for medical or healthcare purposes.
In a press release dated July 19, the administration explained that the proposed guidelines will only impact applications that “are used as an accessory to a medical device already regulated by the FDA” or “transform a mobile...
Boston Scientific CEO Ray Elliott celebrated the Fourth of July by exercising his right to freedom of speech. Three days after an attempt to repeal the medical device excise tax stalled out, Elliott wrote an opinion piece in the Minneapolis StarTribune calling for Congress to “immediately repeal the medical device tax included in the year-old national health care law.”
Elliott’s...
The Advanced Medical Technology Association on Monday laid out a set of policy recommendations it says should be implemented in order to maintain the United States' position as the world leader in medical technology innovation.
"We know medical technology has a bright future. The question is: will that future be made in America—or somewhere else?" AdvaMed President and CEO ...
What a wild week it was at the Embedded Systems Conference (ESC). I spent Tuesday and Wednesday last week in San Jose with the world’s leading embedded developers and came back with some great ideas.
The highlight of the trip was a meeting with Steve Wozniak (co-founder of Apple). It was an impromptu meeting, but one I’ll surely remember. Steve was the event’s keynote...
The healthcare industry has been trying to cut the electric cord since the 1950s when Earl Bakken and Palmer Hermundslie invented the first transistorized cardiac pacemaker with an internal battery. Over the ensuing decades, manufacturers have continued to introduce devices—hearing aids, digital thermometers, defibrillators, nerve stimulators, suction pumps, ultrasound equipment, all manner...
Emergo says mobile medical apps should soon see some guidance.
"Manufacturers have thus far received little official guidance from FDA regarding how CDRH would handle mobile medical applications. Although some medical devices incorporating mobile applications have already been cleared by the FDA—GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’...
The New York Times recently stepped into the world of medical imaging (again) to show what can go wrong when workers aren't trained properly. Although news of it only surfaced this month, a doctor at a NY hospital discovered four years ago that premature babies were being given full-body x-rays. In addition, radiation levels on CT scanners were set too high for infants and the babies weren't...
Play nice. That would be my advice for both the European Commission's health and consumers department and FDA. And it hasn't typically been a problem. But EC officials were miffed after CDRH director Jeffrey Shuren made some opaque remarks about the safety of medical devices in the United States vs. the European Union. Devices reach the market faster in Europe, but Shuren has repeatedly said...
Less than a week ago, Philips revealed that it was investigating possible bribery involving one of its subsidiaries. (In case you're curious, the bribery law in question is the U.S. Foreign Corrupt Practices Act, which you can read more about here).
Dow Jones now says that 16 hospital directors accepted bribes from Philips' representatives totaling about $1.04 million. However,...
It wasn't long ago that we encouraged readers to keep track of FDA's new innovation pathway. We hold to that. But since FDA has been busy creating other paths to market—namely the new Class I Medical Device Data Systems category—it makes sense for folks to keep a close eye on that as well. From FDA's news release:
Medical Device Data Systems are off-the-shelf or...
Philips Electronics revealed in a regulatory filing earlier today that it is reviewing sales of its medical equipment because those sales may violate U.S. foreign bribery law. The investigation is tied to an incident in 2009 in which three workers involved in equipment sales at the subsidiary Philips Polska were indicted. —Lawrence Lloyd
Three-dimensional technology continues its penetration in the medical device technology market. Hologic has just earned FDA approval of its Selenia Dimensions System, the first 3-D mammography imaging system ever approved by the agency.
"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,...
Following up on our previous post, the FDA panel reviewing the classification of devices used in electroshock therapy (also known as electroconvulsive therapy, or ECT) recommended that the devices remain in Class III and undergo the strict premarket approval testing that is required by that designation.
After a two-day meeting to review the treatment, which, according to the...
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