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FDA Publishes Final Guidance for Medical Device EMC

The U.S. Food and Drug Administration (FDA) issues final guidance for medical device electromagnetic compatibility (EMC). The final guidance document details a number of primary components that are needed from U.S. manufacturers in order to obtain premarket clearance or approval for supporting claims of medical device EMC.

IEC Publishes Technical Report on Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC TR 60601-4-2:2016. This technical report covers "Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems."

Electrical Graphene Chip Detects DNA Mutations

Researchers have taken a big step toward developing an implantable chip that can detect DNA mutations in real-time and transmit them wirelessly to a smartphone or computer. A team of bioengineers and the University of California, San Diego designed an electrical graphene chip that can detect a common mutation in DNA.

Terahertz Laser Detects Skin Cancer

An electrical engineer at the University of Queensland has developed a prototype for a terahertz laser imaging system that can identify tumors in their early stages.

Upcoming Effective Dates for Medical Electrical Equipment Safety Standards

Several medical electrical equipment standards are approaching their effective dates for the U.S. Food and Drug Administration (FDA) and the European Union (EU)’s DOCOPOCOSS (Date of Cessation of Presumption of Conformity of the Superseded Standard).
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FDA Seeks Comments on 3D Printing for Medical Devices

The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.

New Synthetic Models for Testing Communications via Human Body

Researchers at the Universitat Politècnica de València in Spain developed new synthetic models that simulate the electromagnetic properties of human tissues and organs. They will be used for developing and testing medical devices that use human tissue as a transmission medium for communication.

Wearable Artificial Kidney Could Give Freedom to Dialysis Patients

The results of a breakthrough clinical trial for a wearable artificial kidney device have...

Radar and Sensors Aid with Medical Care for the Elderly

Researchers at the University of Missouri (MU) are developing technology that can help elderly people remain in their homes longer by providing long-term medical monitoring. Radars and sensors placed throughout the home can identify subtle physical and behavioral changes that can alert patients and caregivers to early signs of illness.

Battery Packs Used on Patient Monitors Recalled for Fire Risk

Medtronic Respiratory & Monitoring Solutions is recalling certain battery packs due to a manufacturing...
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