Dermanostic, a German company based in Düsseldorf, is facing an ongoing legal challenge over the risk classification of its teledermatology software platform from competitor company, Online Doctor 24 but has so far been successful in defending its case.
German Row Over Classification Of Telemonitoring Software Looks Set To Rumble On
Potential implications for telemonitoring software developers across the EU
When does an app qualify as a medical device and when does it not? A German court case appears to have wider-reaching implications for medtech than might first appear.
More from Europe
• By
Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
• By
The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
• By
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.
• By
As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
More from Geography
• By
Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.
• By
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
• By
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.