The Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.
MilliporeSigma received a $136.7 million contract award from the U.S. Department of Defense (DoD), on behalf of the U.S. Department of Health and Human Services (HHS), to support the new facility. It will be the company’s first U.S.-based facility capable of producing diagnostic-grade membrane.
The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.
The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
The two new members bring more than 40 years of leadership and IT experience to the HUMA.AI advisory boards, following a recent round of funding and the introduction of new post-market surveillance technologies.
Not talking, doing is the mantra of the medtech professionals behind Diversity by Doing (DxD), an organization committed to helping small- to mid-sized medtech companies build a foundation of diversity, equity and inclusion into their companies’ DNA.
The research team used focused rotary jet spinning to create polymeric materials that were then seeded with cardiomyocytes to create a biohybrid model of human ventricles with helically aligned beating cardiac cells.
Balwani was charged with 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors.
The committee will be discussing skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings as well as the potential reclassification of approved computer-aided melanoma detection class III devices.
Guidance includes information about what’s protected—and what is not—when using period trackers and other health information apps on smartphones.