Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
Vesalio announced two FDA 510(k) clearances for its aspiration devices for peripheral and neurovascular applications, ...
The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.
Medical Device Network on MSN
Zimmer Biomet secures FDA approval for ROSA Knee with OptimiZe system
Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
Medical Device Network on MSN
FDA clears Onward’s ARC-EX System for home use in spinal cord injury care
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System ...
The smart thermometer performs a check-up on your body temperature, cardiac, and pulmonary health in less than a minute.
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Two Chicago-area medical device companies announced federal clearances for their respective spinal surgery devices.
The U.S. DOJ announced that B. Braun subsidiary Aesculap agreed to pay $38.5 million to resolve allegations under the False ...
Withings announced that its multi-function medical device BeamO has received clearance from the FDA. BeamO contains sensors to perform an electrocardiogram, a stethoscope and a thermometer. The ...
Ethicist Art Caplan discusses FDA layoffs and their impact on protection of human research subjects in clinical trials.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback