Deep Breath B.V.

Deep Breath B.V. develops AI-based platforms designed specifically for intensive care units (ICUs). These systems focus on collecting and analyzing high-resolution data from existing medical devices in real time. The solutions support clinical decision-making, quality management, and educational applications within ICU settings. Their products are not standalone medical devices but rather integrated platforms that enhance the functionality of existing equipment.

Deep Breath B.V. is based in the Netherlands. Since its devices fall under the scope of the EU Medical Device Regulation (MDR), they must comply with MDR requirements. The company’s products are registered in the EU’s official database, eudamed, which tracks medical devices authorized for use within the European Economic Area.

Deep Breath B.V.’s devices are classified as Class I and Class IIa under the EU Medical Device Regulation (MDR). Classification is determined by factors like intended use, risk level, and interaction with the patient. Class IIa devices pose a moderate risk, requiring additional scrutiny and compliance measures compared to Class I, which are considered low-risk. The classification ensures appropriate regulatory oversight based on the device’s potential impact on patient safety.

Yes, Deep Breath B.V.’s devices are registered in eudamed, the EU’s official database for medical devices. This registry is maintained by the European Medicines Agency (EMA) and is required under MDR for all authorized medical devices placed on the EU market. Listing in eudamed ensures transparency, allows healthcare professionals and regulators to verify device compliance, and facilitates traceability in case of recalls or post-market surveillance activities.

Deep Breath B.V.’s platforms are designed to be vendor-independent, meaning they can interface with a wide range of medical devices already present in ICUs without requiring proprietary hardware. The systems collect high-resolution data in real time, process it using AI algorithms, and provide actionable insights for clinical decision support, quality management, and research. This integration allows hospitals to leverage their existing infrastructure while adding advanced analytics capabilities.