News: Medical e-News Round-Up - Issue 49

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New Rigel 288 safety analyser is a big Plus for faster medical device testing

The new Rigel 288 Plus from Rigel Medical brings faster and safer testing of medical devices and installed equipment in hospitals and healthcare facilities.

In this new battery powered tester, Rigel’s renowned 288 automated safety analyser incorporates new features to provide enhanced performance and faster testing of electrical safety in accordance with IEC/EN 62353, AAMI/IEC /EN 60601-1, IEC 61010, NFPA-99 and AS/NZ 3551.

The Rigel 288 Plus now offers insulation testing between 50 VDC - 500 VDC to meet the test requirements of low voltage DC power supplies, and because it is the smallest analyser of its type, it is easier to transport from site-to-site by field engineers.

Point to point leakage tests can now be carried out from battery power alone, making the Rigel 288 plus a highly portable instrument for testing leakage, earthbond and insulation without the need of connecting to mains power.

The 288 Plus also features Rigel’s unique earth bond technology, which combines high and low test current to ensure the accuracy of the protective earth path, helping to accurately identify any potential wear and tear and it is the only tester providing automated verification of secondary earth paths and incoming mains configuration.

John Backes, Associate Director at Rigel Medical, said the company has moved to meet the market need to improve the test functionality of the popular 288, delivering faster and safer testing of medical devices and installed equipment. He said: “Our customers wanted even more flexibility by testing medical installations and fixed installed equipment for earth continuity and leakage current using batteries alone. Now they can with the new Rigel 288 Plus.”

Review of key medtech market regulatory changes

In a special review, the trade publication Medical Device and Diagnostic Industry has taken an interesting look at the main regulatory changes in five major medtech markets around the world.

The Global Regulatory Update 2015 provides an overview of the main changes in the medical device markets of India, China, Japan, South Korea and Brazil. All of these countries have seen updates to their regulatory systems of late and the review looks at their future trends and prospects.

In summary the article concludes that the five medical device markets covered reflect major differences regarding ease of market entry and compliance from country to country.

For example, while regulators in Japan, South Korea, and Brazil seem to be moving toward less cumbersome requirements, China’s CFDA apparently has not taken similar steps (yet). In India, meanwhile, the regulators’ efforts to develop a more comprehensive registration process remain a work in progress.

A full copy of the review is available here.

Increase in FDA medical device approval fees

The US Food and Drug Administration (FDA) is raising medical device user fees for fiscal year 2016.

The new rates will take effect starting Oct. 1, 2015 and remain static through Sept. 30, 2016.

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), the FDA is allowed to collect user fees for medical device submissions or applications in order to supplement the agency's federally-appropriated funding.

In exchange, the FDA is expected to use the additional revenue from user fees to conduct more efficient, timely, and transparent reviews.

The standard fee for a premarket application, product development protocol, biologics licensing application, premarket report, and BLA efficacy supplement, is set at $261,388 each for FY 2016. Fees for other submissions are calculated as varying percentages of that amount.

The US Advanced Medical Technology Association (AdvaMed) is lobbying for additional legislation, such as the FDA SOS Act, to exempt FDA user fees from sequestration measures.

Full story here

Strong market for medical device electronics predicted

A new market report looks at the future of the integrated circuits market in wireless portable medical devices (WPMDs).

The global analysis and forecast review predicts that the global integrated circuits market in WPMDs is projected to grow at a compound annual growth rate of 13.5% during the forecast period of 2014 to 2019.

The growth of the global ICs market in WPMDs is driven by factors such as the increasing use of ICs in application areas such as ECG/EKG monitor, heart rate monitor, and blood pressure monitor, among others. In the global market, the Power IC (PMIC) and driver IC segments are expected to be the highest revenue-generators and drive the market in the coming years.

In this report, the global ICs market in WPMDs has been broadly classified on the basis of type into Power IC (PMIC), driver IC, and logic IC. The PMIC and driver IC segments together accounted for a market share of 74.9% in 2014 and are projected to grow at CAGRs of 13.3% and 14.2% respectively, during the given forecast period.

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Dates for your diary

Rigel’s US-based electromedical test specialists will be out and about at forthcoming trade shows.

You can catch up with all the latest Rigel developments and product introductions at the Florida Biomed Symposium (1-3 October, booth 321) to be held at the Disney Colorado Springs Resort, Orlando, Fl. Also in October, Rigel will also be attending the MD Expo (21-23 October, booth 114) at the Redrock Casino, Las Vegas.

Jack Barrett, Rigel’s US based representative will be happy to meet you at either or both events. Full details at www.rigelmedical.com/