The Food and Drug Administration has released a draft guidance outlining a pilot program designed to accredit third-party testing laboratories for premarket review of medical devices.

The number of ambulatory surgery centers in the U.S. is growing, as is the number of procedures these outpatient centers perform.

How can a patient’s perspective improve the design of the medical devices that they use?

George Washington University Hospital has partnered with Novarad, a Salt Lake City, UT–based company that provides healthcare IT and imaging solutions, to implement what the company says is the first augmented reality medical solution in a surgical setting.

News from the field.

At this year’s MD Expo in Baltimore, MD, Dennis Wulf, founder and board chairman of Innovatus Imaging, described how his company benefited from implementing a quality management system (QMS) that’s compliant with ISO 13485.

A team of researchers are testing a new artificial intelligence–powered automated system for diagnosing pneumonia from chest radiographs (i.e., X-rays).

The Food and Drug Administration’s Center for Devices and Radiological Health has released its final and draft guidance publication priorities for the 2020 fiscal year.

John Wilkinson is director of devices at the Medicines and Healthcare Products Regulatory Agency, London, UK.

William A. “Bill” Hyman, a dedicated educator, pioneering clinical engineer, and prolific writer passed away in July.

Do you know a health technology innovator, safety advocate, or revolutionary? How about a standards leader or humanitarian? You can make sure that health technology’s finest are recognized for their achievements by nominating them for an AAMI or AAMI Foundation award.

A new AAMI technical information report provides detailed guidance for addressing the unique challenges of maintaining the security of a medical device during its entire life cycle.

Becky Crossley, CBET, is a BMET specialist in the Biomedical Engineering Department at the University of Pittsburgh Medical Center Susquehanna-Williamsport in Williamsport, PA.

University of Connecticut students attend simulated patient training.

This regular feature showcases questions and answers from professionals participating in AAMI’s online discussion groups, collectively known as AAMI Connect. AAMI does not endorse specific practices or advice. Participants in these forums are sharing their own experiences and insights.

Nadia Ayoubzadeh led the launch of a new customer service training program that focuses on developing soft skills—i.e., people skills or professional skills—for IS and clinical engineering employees.

HERMAN MCKENZIE, MBA, CHSP, is director of the department of engineering, standards interpretation group at The Joint Commission in Chicago, IL.

Meet Sweta Gupta, a biomedical engineering project manager at Biomedical Services Inc., Prime Healthcare, in Ontario, California.

Who, what, and where and AAMI members.

The National Electrical Manufacturers Association has published a revision of its Manufacturer Disclosure Statement for Medical Device Security (MDS2), providing device manufacturers with an expanded and standardized form for collecting data about their products’ security capabilities for customers.