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Updated: 4 hours 47 min ago

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.

TRIMEDX Completes Acquisition of Aramark’s Healthcare Technology Business

Mon, 2018-11-19 23:00
TRIMEDX closed a $300 million deal to buy Aramark’s Healthcare Technologies business last week, adding more than 500 U.S. healthcare providers that used HCT for clinical engineering services to its portfolio.

AAMI’s New Office Transforms the Member Experience

Sun, 2018-11-18 23:00
AAMI staff have finished moving into a new state-of-the-art office space that will bring new opportunities for members, standards professionals, and the health technology community.

Next Generation Wireless Technology Predicted to Have ‘Tremendous Impact’ on Healthcare

Mon, 2018-11-12 23:00
As health technology grows increasingly connected, the launch of a fifth generation of wireless technologies (5G) is poised to impact the industry. This new generation of technology promises to deliver WiFi-like speed throughout the network, the ability to connect millions of devices simultaneously, and low latency (the delay between receiving and sending signals).

FDA Pushes Back Direct Label UDI Requirements

Mon, 2018-11-05 23:00
The Food and Drug Administration (FDA) is giving medical device manufacturers additional breathing room to adopt unique device identification (UDI), specifically as it relates to direct mark requirements, in which a UDI is placed directly on a reusable device that is reprocessed between uses.

FDA Announces Proposed Guidance for FY 2019

Thu, 2018-11-01 23:00
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has announced the guidance documents it intends to publish in fiscal year (FY) 2019, and the topics include prioritizing digital health, advancing device safety and security, and engaging patients.

FDA to Host Workshop on Medical Device Servicing and Remanufacturing

Mon, 2018-10-22 23:00
The Food and Drug Administration (FDA) has opened registration for a public workshop on Dec. 11–12 as part of what it describes as “the agency’s continued commitment to promoting high-quality, safe, and effective medical device servicing and remanufacturing.”

Medtronic’s Earl Bakken, AAMI and Industry Pioneer, Dies at 94

Mon, 2018-10-22 23:00
Earl Bakken, a driving force in AAMI’s infancy and chairman emeritus of Medtronic, a multi-billion-dollar medical technology company that he co-founded in a Minneapolis garage, passed away at his home in Hawaii on Oct. 22. He was 94.

FDA Issues Cybersecurity Premarket Guidance

Sun, 2018-10-21 23:00
In an effort to stay “a step ahead” of cybersecurity vulnerabilities, the Food and Drug Administration (FDA) has issued a draft guidance to help manufacturers incorporate cybersecurity best practices into their medical devices and address threats before entering the market.

Preparing for an AI Revolution in Healthcare Technology

Sun, 2018-10-14 23:00
Healthcare organizations are generating and collecting enormous amounts of data. Coupled with advances in wearable technology and sensors, the conditions are ripe for artificial intelligence (AI) and related technologies forever changing the healthcare technology field in the coming years.

Competition Seeks to Bridge Gap for Pediatric Medical Devices

Mon, 2018-10-08 23:00
“There has to be a better way.” That was the theme for the healthcare technology innovators, clinicians, regulators, and investors who convened in Philadelphia earlier this fall to discuss, encourage, and—perhaps most important—provide a total $150,000 in grants for six companies developing innovative healthcare technology that focuses on the needs of children.

FDA Announces Special 510(k) Program Pilot

Mon, 2018-10-01 23:00
The FDA has announced the launch of a pilot program that would test an expansion of the agency’s Special 510(k) premarket clearance process, an optional—and faster—pathway to clearance for certain well-defined modifications to a manufacturer’s own medical device. All Special 510(k) submissions received on or after Oct. 1, 2018 will be included in the program pilot, according to the FDA.

Dave Harrington, ‘Larger Than Life’ Clinical Engineer, Dies at 77

Sun, 2018-09-30 23:00
Dave Harrington, a longtime clinical engineer who was beloved by the healthcare technology community, died last week after a long illness. He was 77. Harrington, who lived in Medway, MA, was known by his friends and colleagues as a dedicated educator, prolific writer, and volunteer who had a true love and commitment to the field and helping others.

Blockchain Technology Moving into Healthcare

Sun, 2018-09-23 23:00
What is blockchain, and what does it mean for healthcare technology?

FDA Panel to Discuss Ways to Harness Social Media to Help Evaluate Medical Devices

Thu, 2018-09-20 23:00
The FDA will hold a public meeting on Nov. 15 to discuss how it might leverage social media to inform the regulatory evaluation of medical devices and healthcare technology.

TRIMEDX to Buy Aramark’s Healthcare Technologies Business

Mon, 2018-09-17 23:00
Two major providers of healthcare technology management services are coming together. TRIMEDX, an Indianapolis-based company focused on clinical asset management and clinical engineering services, has announced a $300 million purchase of Philadelphia-based Aramark’s Healthcare Technologies (HCT) business.

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