11-03-2022 Currently, FUSE-AI is preparing the certification of the software Prostate.Carcinoma.ai for MDR IIa and FDA 510k. The contracts have already been signed in July by BSI as the notified body. . NSF / Prosystem is on our side as a supportive consulting company for a fluent certification process. "The experienced consultants of NSF impressed…

07-28-2022 Matthias Steffen and Dr. Andreas Raguse (Radiology Consultant of FUSE-AI) visited the European Congress of Radiology (ECR) in Vienna. On July 15, they jointly received a market overview of software solutions for AI-based image recognition in radiological diagnostics at one of the most significant radiology congress. New and already available business contacts were keenly…

07-28-2022 Despite all oppressive circumstances that are currently making life hard for medical device manufacturers - and which could potentially threaten the existence of some of these companies - we have succeeded: FUSE-AI and their products will be certified by the Notified Body BSI Group! "We are pleased about our new client FUSE-AI GmbH from…

Bundesministerium für Gesundheit entscheidet Fast Track für Digitale Anwendungen im Digitalen Versorgungs Gesetz (DVG) Am 09. Juli fand das Get Started Health Network #11 im Bitkom Office in Berlin mit Julia Hagen (Director Regulatory & Politics, hih), Sophia Matenaar (Bundesministerium für Gesundheit) und Dr. Lars Hunze (Bundesministerium für Gesundheit) statt. Gegenstand der Veranstaltung war einerseits…