Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, ...

Despite hypertension being a highly recognized, potent, and modifiable cardiovascular risk factor, it remains the leading cause of death and disability worldwide [1]. It is essential that the blood ...

The AAMI/ESH/ISO Universal Standard considers children as a “special population” for validations requiring separate investigation [3,4,5]. For BP devices intended only for children, a full 85-subject ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Real-World Plasma Thymidine Kinase Activity in High-Risk and Metastatic Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer Treated With Cyclin-Dependent Kinase ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The communication IPs (Intellectual Property) designed for and used across industry follow standard protocols. They need to interact with either data transmitters or receivers present on other SOCs ...