Focus

Amendment 1 to IEC 60601-1:2005

13 May 2013 For more than 35 years, IEC 60601-1 has been one of the most widely recognized standards for demonstrating the safety of medical electrical equipment. The IEC 60601 family of standards has long been recognized by regulatory agencies in Europe, North and South America, and Asia as establishing conformance with their regulatory requirements....

Bluetooth Health Device Profile: Compatible Communication for Specialized Devices

Part 1 The Health Device Profile along with the IEEE 11073 protocol is enabling a number of specific medical devices to communicate data via multiple logical channels carried by a single master radio channel for compatible device communication. Profiles play a central role in the Bluetooth Specification. They define the entire protocol stack, usually including...
Interview with Doug Busch of Intel-GE Care Innovations

Interview with Doug Busch of Intel-GE Care Innovations

The medical electronic market continues to heat up as more and more people demand medical electronic solutions. Intel and GE, the two electronic giants formed a joint-venture called Intel-GE Care Innovations. MEDS wanted to find out how it came about and what they wanted to accomplish. Our publisher John Koon interviewed Doug Busch, Senior Vice...

CES 2012: Digital Health Reality Check

I attended the CES 2012 in search of new and interesting ideas for MEDS (Medical Electronic Device Solutions magazine www.medsmag.com). According to CES, this year the record attendance reached 153,000.I attended two panel discussions. Compared to the conferences I attended last year, there were a lot of repeated themes such as the importance of wireless...
Software Platform for Medical Devices Complete with Compliance Documentation

Software Platform for Medical Devices Complete with Compliance Documentation

A new software platform for medical devices is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, U.S. Food and Drug Administration’s (FDA) 510(k), or the more stringent premarket approval. The Wind River Platform for Medical Devices is a commercial off-the-shelf (COTS) development and run-time platform enabling...
Ultra-low-Dose CT Technology with Greatly Improved Image Clarity

Ultra-low-Dose CT Technology with Greatly Improved Image Clarity

GE Healthcare has announced 510(k) clearance of its new Computed Tomography (CT) technology, called Veo, which may help physicians deliver accurate diagnoses by enabling profound CT image clarity at dramatically lower dose. Veo represents what is called Model-based Iterative Reconstruction (MBIR) technique, and is already available on GE Discovery CT750 HD systems in Europe, Canada...
250 Watt Medical Power Supply in low Profile 3” x 5” Package

250 Watt Medical Power Supply in low Profile 3” x 5” Package

A new series of AC/DC power supplies offers 250 watts of performance-packed design and is compliant to UL/cUL60601-1 and TUV 60601-1 medical safety standards. Units also bear the CE Mark and are RoHS compliant. This lowprofile PPWAM250 Series from Power Partners is suitable for a variety of patient vicinity medical and dental applications. The PPWAM250...

GE’s radiology Mobile Access receives FDA Clearance for Advanced, Diagnostic CT and Mr Image review

GE Healthcare has demonstrated new capabilities for its Centricity Radiology Mobile Access platform, enabling radiologists to use their iPad and iPhone devices to remotely diagnose select patient images from Centricity PACS. Centricity Radiology Mobile Access 2.0 is a mobile product with clearance for primary diagnosis that accesses images and reports from Centricity PACS. This new...

Siemens’ Iterative reconstruction Protocol Cleared by FDA

A new generation of image reconstruction software and hardware has reportedly been developed within Siemens Healthcare’s initiative Agenda 2013, which allows for a robust reduction of radiation dose in CT examinations. And recently, Siemens Healthcare has announced that its computed tomography (CT) iterative reconstruction algorithm SAFIRE—Sinogram Affirmed Iterative Reconstruction—has been cleared for domestic sale by...

Philips Opens Hospital research Area to Develop Innovative Healing Environments

Royal Philips Electronics has announced that it is stepping up its healthcare re- search into healing environments by opening a dedicated research facility at its Eind- hoven-based Research Laboratories. Based on Philips’ understanding of the hospital patient experience and implemented through the intelligent use of technology, the heal- ing environments concepts aim to accelerate and...
IEC 60601 Update

IEC 60601 Update

First published by the International Electrotechncial Commission (IEC)[1] in 1977, IEC 60601 has become the most widely recognized international family of standards dealing with the safety of medical electrical equipment and systems. The third edition of IEC 60601-1 published in 2005 introduced a major new paradigm for dealing with the safety of electrically powered medical devices...
Compact CT System Offers Enhanced Diagnostic Ability at Optimized Dose

Compact CT System Offers Enhanced Diagnostic Ability at Optimized Dose

GE Healthcare has announced FDA clearance of Optima CT660—a powerful and compact Computed Tomography (CT) system offering improvements from its predecessors in diagnostic capabilities at low dose levels, and designed for sustainability and ease-of-use. Powered by GE’s advanced CT technologies and applications, this intelligent platform is scalable from 32 to 128 slices through purchasable options...