Medical

With two recalls on implanted devices and the impending threat of major cyber attacks, St. Jude Medical Inc. has begun looking for solutions to its compounding problems.

The FDA's approval of the first hybrid closed loop pump and sensor is a major game changer for people living with diabetes. Here's why this design is a big deal, and what it means to people coping with this illness.

Common FDA Regulatory Pathways for Uncommon Devices

A team of engineers led by Tufts University have created smart medical thread using embedded sensors to monitor, collect, and wirelessly transmit patient data in real time. This new development in thread-based diagnostic devices (TDDs) will serve to continuously monitor of patients' health status, diagnose, and treat diseases.

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.

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."

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.

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.

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Administration (FDA) and the European Union (EU)’s DOCOPOCOSS (Date of Cessation of Presumption of Conformity of the Superseded Standard).

The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.