As of August 2021, the 510(k) submission for the FreeStyle Libre 2 IOS App Glucose Monitoring System designed by...
FDA
Designing a Joint Replacement
As technology and science in medicine continue to progress, joint replacements continue to prove a challenge...
Aduhelm, an Accelerated Approval for Alzheimer’s
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s...
Impact of COVID-19 on People of Color
As the COVID-19 pandemic hit the United States, people of color were bearing the brunt of the virus. African Americans...
Trends In 2020 FDA Pharma Warning Letters
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
Non-Destructive Testing Methods
Non-destructive testing methods are critical in characterizing the properties and features of any material or product...
Sex Differences in Infectious Diseases
Women and men are different in many aspects when it comes to disease-causing pathogens. An interesting fact is that...
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
Label Warning for Pfizer and Moderna
Last week, the FDA announced that Pfizer-BioNTech and Moderna will require warning labels for vaccines for young...
Neural Electrode Implants
The brain is a sea of electrical impulses and currents traveling along axons in order to transmit and receive...
Essential Drug Shortages and the FDA
Patients who rely on a consistent supply of needed medication to sustain a normal life, such as insulin or heparin are...
Blood Test Supports Cancer Screening Use
A study published in Annals of Oncology reported that a blood test can successfully detect more than 50 types of...
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