Medical device security needs to address the cyber-physical threats, not just patient health information risk.
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.
Jennifer Fried, CEO of ExplORer Surgical, explains the stress that COVID-19 has placed on healthcare and the shift in how medical device reps are connecting with hospitals and healthcare providers.
The pandemic has revealed some inadequacies in the way medical device suppliers manage regulated product information. The following is a look back on a challenging year and suggestions for practical improvements to cope with continued uncertainty in 2021.
Physicians need technology that helps them track disease progression and response to therapy.
As one of the nation’s largest industries, and one that is experiencing serious issues with cost, staffing and customer experience, healthcare is a prime candidate for IoT solutions.
To achieve success in this market, device manufacturers should consider working with providers to help contain costs and enhance outcomes.
The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.
Fueled by an urgent need for diagnostic testing to respond to COVID-19, the in-vitro diagnostics market is experiencing explosive growth across Asia and around the globe.
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.