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FDA Delays UDI Enforcement for Some Lower-Risk Devices

Mon, 2018-01-15 23:00
The Food and Drug Administration (FDA) has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk medical devices by at least two years, according to a Jan. 16 guidance document. These requirements were originally scheduled to be enforced starting this fall.

Joint Commission Names Mills’s Successor

Mon, 2018-01-15 23:00
Kenneth Monroe was appointed senior associate director of The Joint Commission's Standards Interpretation Group’s Department of Engineering in late December. Monroe replaces George Mills, who held the position for nearly 13 years.

AAMI Founder, Cardiac Surgeon Remembered for Lasting Contributions to the Field

Thu, 2018-01-11 23:00
W. Gerald Rainer, a renowned Denver heart surgeon and founding AAMI member, died suddenly of natural causes on Nov. 14, 2017, the day after his 90th birthday.

Former FDA Director, AAMI Board Member Dies at 87

Tue, 2018-01-09 23:00
Pioneering medical device regulator and early AAMI leader David Link died on Dec. 23, 2017 in Massachusetts General Hospital.

Medical Device Tax Returns to Dismay of Industry

Thu, 2018-01-04 23:00
After a two-year reprieve that many in the healthcare technology industry expected to be permanent, the medical device tax is back. This 2.3% excise tax on medical device sales, first imposed by the Affordable Care Act (ACA), was reinstated at the start of 2018 to the disappointment of many in the medical device industry. Following the passage of the ACA in 2010, the tax drew increasingly bipartisan opposition. It was eventually suspended—but not repealed—at the end of 2015.

FDA Proposes Program to More Efficiently Report Medical Device Malfunctions

Wed, 2017-12-27 23:00
Medical device manufacturers may soon have a simpler and less time-consuming way to report device malfunctions to the Food and Drug Administration (FDA) using a proposed program developed to cut down on paperwork and improve transparency during postmarket surveillance.

Divisive Medical Imaging Service Standard to Undergo Revision

Tue, 2017-12-26 23:00
A Medical Imaging & Technology Alliance (MITA) Canvass Group failed to reach consensus earlier this month on a draft American national standard for the servicing of medical imaging equipment.

FDA Says Early Clinical Research of Medical Devices Coming Back to U.S.

Wed, 2017-12-20 23:00
More than double the number of investigational device exemptions (IDEs) were submitted in 2017 compared to 2014, a sign that critical clinical research of innovative new medical devices is returning to the United States, according to the Food and Drug Administration (FDA).

HIMSS Conference to Focus on Solving Health IT Challenges

Wed, 2017-12-13 23:00
The Healthcare Information and Management Systems Society (HIMSS) will be holding its annual conference March 5–9, 2018, in Las Vegas, NV.

FDA Draws Line between Regulated and Unregulated Digital Health Products

Wed, 2017-12-13 23:00
The Food and Drug Administration has published three guidance documents, two drafts and one final, intended to clarify the agency’s role in regulating digital health products, including areas where the agency sees no need for its involvement.

FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

Tue, 2017-12-12 23:00
The Food and Drug Administration (FDA) says it will step up its efforts to modernize its review process for medical devices, placing a greater emphasis on the use of postmarket data and relying more on international standards to help evaluate products in 2018.

Hospital Group Calls on FDA to Get Tougher with Device Manufacturers on Cybersecurity

Mon, 2017-12-11 23:00
A national organization representing hospitals of all sizes is calling on the Food and Drug Administration (FDA) to hold manufacturers of medical devices “accountable” for their cybersecurity practices and to flex new muscle in its oversight of industry on this front.

FDA Prepares for ‘Wave of New Technologies’ as 3D Printing Takes Off for Devices

Thu, 2017-12-07 23:00
The Food and Drug Administration (FDA) released its first-ever technical guidance concerning the additive manufacturing of medical devices on Dec. 5.

Health System Turns Safety Scare into Initiative to Improve Training on Complex Health Technology

Mon, 2017-12-04 23:00
Leaders at Memorial Hermann Health System, located in southeast Texas, were able to turn a scary lesson into a patient safety initiative that changed the way its staff looks at and are trained on complex medical devices.

Draft Service Standard for Medical Imaging Equipment Sparks Mixed Reactions

Mon, 2017-11-13 23:00
The Medical Imaging Technology Alliance (MITA) has released a draft of a standard for the servicing of medical imaging equipment to a mixed early reaction from stakeholders. The proposed national standard would apply to any entity that services imaging equipment.

Ten Holiday Gifts from AAMI

Sun, 2017-11-12 23:00
The holidays are here and we would like to share these free gifts that AAMI developed that will help you in the new year!!

Cybersecurity Threats Named Top Health Technology Hazard for 2018

Tue, 2017-11-07 23:00
Ransomware and other cyberthreats are the number one health technology safety concern to watch out for in 2018, according to an annual report published by experts at the ECRI Institute.

Experts Promote Information Sharing to Protect against Growing Cyberthreats in Healthcare

Mon, 2017-11-06 23:00
No organization can go it alone when confronting evolving cyberthreats, according to experts who presented at the Medical Device Innovation, Safety and Security Consortium’s fall conference, held last week in Arlington, VA. For conference participants, information sharing is key to protecting medical devices—and patients—from potential attacks by a variety of actors.

Tech Entrepreneurs, Lawmakers Champion Business Value of Federal Research Funding

Mon, 2017-10-30 23:00
Entrepreneurs from eight technology (six healthcare technology) companies and members of the Senate Competitiveness Caucus shared stories of gritty success and called for more federal funding for basic research during a Capitol Hill briefing with other lawmakers. According to speakers at the Oct. 25 event, such funding is not just essential for fueling innovation but also for strengthening the U.S. economy.

FDA Qualifies First Medical Device Development Tool

Thu, 2017-10-26 23:00
The Food and Drug Administration (FDA) has qualified the first tool under its new medical device development tool (MDDT) program. After approximately 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in their submissions.