medical devices

Medical Device Recalled Due to Electrical Issues

The U.S. Food and Drug Administration (FDA) is reporting the voluntary recall of certain...

Company Warns Insulin Pump May be Vulnerable to Cyber Attack

Johnson & Johnson has issued a warning to diabetes patients and their doctors that...

FDA Proposes Labeling Submission Rules for Some Home-Use Medical Devices

In an effort to make information on the use of certain higher-risk home-use medical...

Batteries in Implantable Defibrillators May Fail

The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical...

FDA Updates Draft Recommendations for 510(k) Device Modifications

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

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FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...

Home Use Medical and Wellness Devices

Why are home use medical and wellness devices drawing so much attention and growing at an explosive rate?

U.S. Marketing Authorization of Novel Medical Devices

Common FDA Regulatory Pathways for Uncommon Devices

Digital Hearing Aids: Designing for EMC Compliance

To protect the hearing health of hearing aid users, researchers in the relevant areas have been studying the effects of EMI on hearing aids.

Alere, Inc. Recalls INRatio Monitoring Systems

Alere, Inc. is voluntarily recalling their INRatio® and INRatio®2 PT/INR Monitoring System after working with the U.S. Food and Drug Administration (FDA).

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FCC to Move Forward on Auto Safety Spectrum Rules

Military and Aerospace EMC: Bandwidths Used in Measurements

FDA Annual Medical Device Regulations Conference Set

Manuel Sierra Castañer Awarded Distinguished AMTA Honor

AMTA Awards Life Membership Award to Peter Collins

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