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Public-Private Partnership Provides ‘Security Roadmap’ for Health Technology

Mon, 2019-02-18 23:00
For the medical device industry, healthcare delivery organizations, and federal regulators, trying to stay ahead of evolving cyberthreats can be a struggle. To support this effort, a public-private partnership of health technology companies, healthcare systems, nonprofit organizations, and federal agencies, including the Food and Drug Administration (FDA), has published a reference guide intended to help stakeholders utilize effective cybersecurity practices during medical device development, deployment, and clinical use.

As QMS Rules Change, Device Industry Likely Faces Short-Term Pain—but Long-Term Gain

Mon, 2019-02-11 23:00
The medical device industry is facing a “big quandary” in the face of changing regulations and requirements for quality management systems (QMS), a dynamic that will challenge the ability of companies to effectively stay atop of the shifting rules of the game and compete on the world stage.

FDA Workshop Tackles Ongoing Cybersecurity Concerns

Mon, 2019-02-04 23:00
On its first day of business following the 35-day government shutdown, the Food and Drug Administration (FDA) brought together medical device manufacturers, healthcare delivery organizations (HDOs), researchers, patients, and other stakeholders for a public workshop focused on what FDA Commissioner Scott Gottlieb called one of the agency’s “most critical device safety challenges and priorities”—cybersecurity.

FDA Looks to Future after ‘Record’ Year

Mon, 2019-02-04 23:00
The Food and Drug Administration (FDA) is celebrating a “record year” with 106 new medical devices receiving approval in 2018. These novel devices include the first artificial iris available in the United States, the world’s smallest heart valve designed for newborns, and artificial intelligence technology to diagnose diabetic retinopathy.

FDA Recognizes 138 Consensus Standards

Mon, 2019-01-28 23:00
The Food and Drug Administration (FDA) has added 138 consensus standards to its online recognition database, including 23 developed by AAMI or AAMI-managed committees.

FDA Extends Deadline for Servicing, Remanufacturing Comments

Wed, 2019-01-23 23:00
The Food and Drug Administration (FDA) has extended the deadline for original equipment manufacturers (OEMs), independent service organizations, and healthcare technology management professionals to weigh in on the agency’s continuing effort to address the longstanding debate surrounding medical device servicing.

Updated AdvaMed Code of Ethics Emphasizes Education, Collaboration

Mon, 2019-01-21 23:00
The medical device trade association, AdvaMed, has approved an update to its code of ethics for healthcare technology companies that will go into effect in 2020. The new code emphasizes the importance of instructing, educating, and training healthcare professionals on the safe and effective use of complex healthcare technology and includes new sections focused on education and marketing programs, communication and technical support, and supporting third-party education and conferences.

Potential ‘No-Deal’ Brexit Threatens Medical Device Industry

Thu, 2019-01-17 23:00
With the United Kingdom fast approaching its March 29 deadline for leaving the European Union, and the looming possibility of a “no-deal” Brexit, medical device manufacturers have been left wondering what lies ahead.

FDA Prioritizes Public Safety during Government Shutdown

Tue, 2019-01-15 23:00
The partial government shutdown, now the longest in U.S. history, represents “one of the most significant operational challenges in FDA’s [the Food and Drug Administration’s] recent history,” according to FDA Commissioner Scott Gottlieb via Twitter. In order to continue to fulfill its mission of “protecting the public health,” the agency is taking extraordinary measures to stretch its remaining budget by tapping into operations expenses and shifting funds generated by user fees.

International Conference to Showcase ‘Innovation in Healthcare Delivery’

Mon, 2019-01-14 23:00
More than 60 experts will take to the stage during Future Healthcare 2019, the UK’s largest exhibition and conference showcasing healthcare products and services to an audience of global buyers. AAMI is a partner for this event, which will focus on “embracing innovation in healthcare delivery.”

With Healthcare ‘Under Constant Cyberattack,’ HHS Releases Guidance

Sun, 2019-01-06 23:00
The U.S. Department of Health and Human Services (HHS) released a four-volume report just before the start of the new year that outlined ways healthcare delivery organizations, from local clinics to large hospital systems, can reduce their risk from the most common cybersecurity threats.

Benefits of Unregulated Digital Health Tools Outweigh Risks, FDA Says

Wed, 2019-01-02 23:00
The benefits of many digital health tools that are not regulated as medical devices outweigh their risks, according to a new report published by the Food and Drug Administration (FDA).

FDA to End Extended GUDID Grace Period

Tue, 2019-01-01 23:00
The Food and Drug Administration (FDA) intends to return to a seven-day grace period for submissions to its Global Unique Device Identification Database (GUDID) early this year.

FDA Finalizes Breakthrough Devices Program

Thu, 2018-12-20 23:00
The Food and Drug Administration (FDA) has issued final guidance that details the policies, features, and application process for the agency’s new Breakthrough Devices Program. The program was established by the 21st Century Cures Act to provide developers with “a more agile process” to get feedback from the FDA during the premarket clearance process, paving the way for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition[s].”

FDA Remanufacturing Workshop Promotes Continued Collaboration

Mon, 2018-12-17 23:00
Stakeholders put their heads together at a Dec. 10–11 public workshop hosted by the Food and Drug Administration in Gaithersburg, MD, with the goal of discussing the distinction between medical device servicing and remanufacturing.

FDA Proposes Improving De Novo Pathway

Mon, 2018-12-10 23:00
As part of its effort to modernize the premarket review of medical devices, the Food and Drug Administration (FDA) has proposed a new rule for its De Novo classification pathway in an attempt to make it more “significantly more efficient and transparent,” according to FDA Commissioner Scott Gottlieb.

Healthcare Technology Leader Eddie Acosta Dies at 54

Thu, 2018-12-06 23:00
Adelmiro “Eddie” Acosta, a healthcare technology leader and U.S. military veteran, died in November after a long battle with cancer. He was 54 years old.

FDA Eyes Shift Away from Predicate Device–Based Approvals

Thu, 2018-11-29 23:00
For more than four decades, medical device manufacturers have relied on comparing new designs against previous iterations of a device, called predicate devices, as a way to gain approval from the Food and Drug Administration (FDA) through its 510(k) premarket clearance process. But now the agency is looking to make what FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, call a “generational change” away from those comparisons as it seeks to modernize the 510(k) premarket clearance process.

FDA Doubles Down on Active Surveillance, Real-World Data

Mon, 2018-11-26 23:00
To reach these heights, the FDA will expand its investment in the National Evaluation System for health Technology (NEST) to allow a “more rapid build-out” of the system to help the FDA collect and analyze the real-world evidence it needs to identify, communicate, and act on medical device safety concerns.

Researchers Develop Comfortable, Transparent Nanoneedle Patch

Sun, 2018-11-25 23:00
Researchers from Indiana’s Purdue University and South Korea’s Hanyang University have developed a patch with flexible needles so small that as many as nine can be injected into a cell without damaging it. The patch is intended to help reduce the discomfort associated with previous, more rigid nanoneedle patch designs.