Medical Devices (Class II and Class III)

Pandemic and supply shortage among factors in slow transition to new rules.

Data shows patients don't always know they are having AF symptoms, bolstering need for continuous monitoring.

ClariMed formed to provide pharma and medical device manufacturers an integrated, human-centric approach to medical product development and is headed by CEO Kelley Kendle.

A Scottish-based research group has developed a stent-graft combination for Type A dissection, which studies show greatly improved survival rate.

Trial will compare patients that undergo cardiac radioablation with Varian's CRA system vs. standard-of-care catheter ablation.

The ACL TightRope® II implant is a new device for reconstructing torn knee ligaments in children and adolescents.

As a medical school and hospital system that provides clinical care on an inpatient and outpatient basis, Mount Sinai also trains medical students and graduate students. One of its goals was to enrich faculty and residency programs and train the next generation of medical scientists by bringing engineering principles to solve problems.

The joint pilot will test the use of a single eSTAR, an interactive form that guides applicants through the process of preparing FDA medical device submissions.

A project led by Illinois Tech Professor of Chemical Engineering Ali Cinar has received $1.2 million from the NIH over the next four years to develop a machine learning system that can be integrated into his artificial pancreas system to enhance the accuracy of the artificial pancreas.

Over the past year, federal agencies, medtech associations, manufacturers and academics have been working out the steps for a predictive pathway to reimbursement that would satisfy seniors’ needs as well as the different mandates of CMS and FDA agencies.

The challenges surrounding projects in this space

Cloud-based Enterprise Labelling helps companies adjust to supply chain challenges.