With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.
There has been another ruling in the legal tussle over the classification under the Medical Device Regulation of an app that some contend is not even a medical device.
The product at the center of the row is Dermanostic, an app designed to help diagnose skin conditions fast, marketed...
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
