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RPM sensors can be affixed to the individual or their assistive mobility devices such as canes and walkers. [4] The sensors monitor an individual's location, gait, linear acceleration and angular velocity, and utilize a mathematical algorithm to predict the likelihood for falls, detect movement changes, and alert caregivers if the individual ...
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Home medical equipment is a category of devices used for patients whose care is being managed from a home or other private facility managed by a nonprofessional caregiver or family member. It is often referred to as "durable" medical equipment (DME) as it is intended to withstand repeated use by non-professionals or the patient, and is ...
The initial list includes common prescriptions such as penicillin, metformin, lithium and albuterol asthma inhalers, as well as drugs for high cholesterol, high blood pressure and other chronic ...
The Food and Drug Administration (FDA) Center for Devices and Radiological Health, which regulates home medical devices, has been receiving an increasing number of “adverse event reports ...
It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines. [2] The PhMDA has been eCTD compliant at least since December 2017 ...
Embotrap III Revascularization Device [7] Embovac Aspiration Catheter [8] Cerenovus Large Bore Catheter [9] Cerenovus Nimbus [10] Cerebase DA Guide Sheath [11] Trufill n-BCA Liquid Embolic System [12] Orthopedics (DePuy Synthes) Velys Digital Surgery platform [13] Attune Cementless Fixed Bearing Knee [14] Actis Hip Stem [15] Inhance Shoulder ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.