News | AAMI

Recent News

FDA Resumes Inspections After COVID-19 Halt
The Food and Drug Administration (FDA) has resumed some domestic facility inspections following a temporary halt in in March as cases of COVID-19 increased in the United States.
FDA Issues Final Guidance on Electronic Submissions for Medical Devices
The Food and Drug Administration (FDA) has issued final guidance on electronic submissions for medical devices. However, the agency says one guidance document is insufficient for all the information that needs to be shared with industry and more communication will be coming from the FDA on specifics such as electronic formats and timing for implementation of the new guidance.
COVID-19 Innovations Highlighted at Pediatric Device Competition
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), based in Washington, DC, recently announced eight winners in a special pediatric device competition focused on treating COVID-19. Among the winners were a DIY origami facemask that shows facial expressions and improves communication, a portable smart ICU ventilator for both children and adults, and a wearable platform for remote patient monitoring of vital signs.
CMS, FCC Push for Permanent Telehealth Expansion
Actions by both the Federal Communications Commission (FCC) and the Centers for Medicare & Medicaid Services (CMS) are on track to establish telemedicine as a permanent fixture of the United States healthcare system during and after the COVID-19 pandemic.

Press Releases

AAMI Consensus Reports Guide ‘Bubble Helmet’ Development as COVID-19 response
AAMI's COVID-19 response team has released two consensus reports (CRs) to guide manufacturers in making safe and reliable ventilatory assistance helmets - bubble-like helmets designed to delay a patient's for an invasive mechanical ventilator.
CINDE and AAMI Bring Medical Device Industry Training to Costa Rica
Recognizing Costa Rica's growing importance to medical device manufacturing, the Association for the Advancement of Medical Instrumentation (AAMI) has joined forces with the Costa Rican Investment Promotion Agency (CINDE). The collaboration will bring the highest quality professional training in standards utilization and product development to Costa Rica’s device manufacturing campuses.
AAMI to Leverage Cognitive Science to Deliver Online Training
AAMI is announcing a new strategic partnership with Amplifire, the leader in leveraging cognitive science to radically improve training outcomes. As a part of the partnership, AAMI will become a member of the Amplifire Healthcare Alliance, leveraging AAMI expertise to add medical device and health technology courses to the Alliance network.

Newsletters - the latest in your inbox

AAMI Newsweekly

Delivered to your inbox midweek, giving you a broad overview the latest in health technology news and at AAMI. Update your AAMI profile to subscribe.

Subscribe Now

Tech News Net

For clinical engineers, biomedical equipment technicians, and other healthcare technology management (HTM) professionals, this monthly newsletter provides a concise roundup of news in the health technology world. Update your AAMI profile to subscribe.

Subscribe Now

Sterilization Today

An essential resource for sterilization professionals, this newsletter provides a curated focus on news about both hospital and industrial sterilization. Update your AAMI profile to subscribe.

Subscribe Now

The Latest in Health Technology, Sterilization, and Industry

Recent News

Press Releases

AAMINews

Newsletters - the latest in your inbox

AAMI Newsweekly

Tech News Net

Sterilization Today