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Updated: 3 hours 24 min ago

FDA Issues Final Guidance on 510(k) Submissions for Peripheral Vascular Atherectomy Devices

Mon, 2020-02-17 23:00
A final guidance document issued by the Food and Drug Administration (FDA) on Feb. 13 details recommendations for 510(k) submissions for peripheral vascular atherectomy devices, which are designed to remove plaque from arteries outside of the heart. The guidance pertains specifically to atherectomy devices used in the peripheral vasculature (regulated under 21 CFR 870.4875 with product code MCW).

Health Technology Alliance to Offer Interoperability Session at HIMSS20

Tue, 2020-02-11 23:00
The Health Technology Alliance (HTA), a joint collaboration between AAMI, the American College of Clinical Engineering (ACCE), and the Health Information Management Systems Society (HIMSS), is developing a session for the 2020 HIMSS Global Health Conference & Exhibition (HIMSS20) that explores the increasing connectiveness of medical devices—as well as the importance of minimizing potential security risks.

FDA Reclassifies Certain Medical Image Analyzers

Mon, 2020-01-27 23:00
In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration (FDA) identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required. The final order, which was published in the Federal Register on Dec. 30, amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

AAMI Risk Management Standard, TIR Recognized by FDA

Tue, 2020-01-14 23:00
The FDA has designated two AAMI risk management resources as recognized consensus standards: ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices and AAMI TIR97, Principles for medical device security—Postmarket risk management for device manufacturers.

FDA Exempts Some Devices from Premarket Notification

Sun, 2020-01-12 23:00
In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration (FDA) identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required. The final order, which was published in the Federal Register on Dec. 30, amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

First Fully Disposable Duodenoscope Receives FDA Clearance

Tue, 2020-01-07 23:00
The Food and Drug Administration (FDA) has granted 510(k) premarket clearance to the first fully disposable duodenoscope. The EXALT Model D duodenoscope, developed by Boston Scientific, is intended to eliminate the risk of transmitting infection-causing bacteria from one patient to another.

FDA Final Rule Requires Medical Device Submissions in Electronic Format

Mon, 2019-12-16 23:00
Effective Jan. 15, 2020, medical device premarket submissions will be required to be sent in electronic format, according to a final rule issued by the Food and Drug Administration (FDA) on Dec. 16.

Stephen Hahn Confirmed as FDA Commissioner

Mon, 2019-12-16 23:00
The U.S. Senate confirmed Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center in Houston, TX, as the new Food and Drug Administration (FDA) commissioner. This will be Hahn’s first government post for Hahn, a radiation oncologist and educator.

Performance Criteria for Magnetic Resonance Coils Detailed in FDA Draft Guidance

Mon, 2019-12-09 23:00
In support of the Food and Drug Administration’s Safety and Performance Based Pathway framework, the agency has specified performance criteria for magnetic resonance (MR) coils in a Dec. 6 draft guidance.

FDA Approves Myopia-Slowing Contact Lens for Children

Thu, 2019-12-05 23:00
The Food and Drug Administration (FDA) has granted premarket approval for the first contact lenses shown to slow the progression of myopia (i.e., nearsightedness) in children aged 8–12. The soft, disposable contact lenses, called MiSight, sharpens distance vision like a typical contact lens. Concentric rings help prevent the eye from elongating and progressively worsening the condition.

Webinar Will Provide MDS2 Insights

Wed, 2019-12-04 15:07
Join us for a free webinar hosted by the Health Technology Alliance to learn about the new version of the Manufacturer Disclosure Statement for Medical Device Security form and why it’s important for your organization.

CDRH Pilot, Innovation Challenges Address Ethylene Oxide Hurdles

Mon, 2019-11-25 23:00
The Food and Drug Association (FDA) Center for Devices and Radiological Health (CDRH) has launched a voluntary pilot project for industry to help facilitate new sterilization methods that use less ethylene oxide (EtO) and hasten approvals for sterilization site relocations. The new program is among the FDA’s recent efforts to prevent potential shortages of safe and effective medical equipment and to reduce reliance on EtO for device sterilization.

FDA Guidance Describes Process for Requesting Review of Denied Export Certificates

Mon, 2019-11-18 23:00
The Food and Drug Administration (FDA) has issued final guidance describing the process an establishment must undertake if seeking review of a denied request for a Certificate to Foreign Government (CFG) for a medical device.

Fully Implantable Heart Pump Wins FDA Breakthrough Designation

Tue, 2019-11-05 23:00
The Food and Drug Administration (FDA) has awarded breakthrough status for an implantable and fully internal left ventricular assist device (LVAD), or heart pump. Developed by Medtronic, the new LVAD design is intended to increase oxygenated blood flow through the body for patients with advanced heart failure without the need for wires leading to an external power source.