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.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
The annual SupplyTech Breakthrough Awards program honors excellence within the supply chain and logistics sectors.
John Mastrototaro, Ph.D., biomedical engineer and CEO of Movano discusses strategies to improve data accuracy, the convergence of consumer wearables and medical remote monitoring devices and what healthcare providers are seeking in remote data delivery.
The pandemic and resulting “Great Resignation” is forcing companies to re-examine their workplace cultures and employee needs. Luke Otto, executive recruiting manager at Actalent, shares insights into what today’s medtech teams are seeking in an employer.
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
