If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.
Peter J. Arduini, president and CEO of GE HealthCare, began his two-year term as Board Chair last Friday. The same day AdvaMed announced its new Medical Imaging Division under the direction of Patrick Hope, former executive director of the Medical Imaging & Technology Alliance.
Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
Computational simulations play a pivotal role in optimizing the design of point-of-care cassettes prior to manufacturing, shortening the development timeline and enabling swift adaptation to market demands.
Recent developments, specifically artificial intelligence and the ubiquity of smart devices, enable us to monitor cough unobtrusively and continuously for periods of time. Objective cough quantification can be combined with patients’ perceptions to better determine diagnosis, treatment response and prognosis.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal of clarifying the requirements for market actors and protecting EU patients.
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.
The test detects all known variants of SARS-CoV-2, including alpha, beta, gamma and omicron.