Dutch startups are developing an increasing number of digital tools aimed at relieving the burden on healthcare professionals in primary care, elderly care and prevention. Their products range from apps that analyse skin abnormalities to sensors that monitor elderly people at home, but all of them run into the same questions around certification and reimbursement.
The healthcare market is demanding: a product that has not been clinically validated or is not reimbursed will rarely make it into everyday practice. That makes the step from prototype to daily use at least as challenging for many of these companies as the technical development itself.
Prevention and early diagnosis via smartphone
SkinVision, founded in 2011 in Amsterdam and backed by a total of approximately €11 million in funding, allows users to photograph a skin lesion, after which an algorithm assesses the risk. The company has obtained MDR Class IIa certification and was previously the first AI-driven medical device to receive CE registration under the old Medical Device Directive. Clinical validation was carried out in collaboration with LMU and Erasmus University. Independent research points to a sensitivity of over 90 percent for the most common forms of skin cancer.
On the reimbursement front, SkinVision is further along than most of its peers. CZ covers the app under the basic insurance package, FBTO offers it free of charge to its own policyholders, and from 1 January 2026, all Aevitae basic insurance holders will be able to use the app at no cost. Zilveren Kruis and Nationale-Nederlanden are also partners. The fact that more than twenty million Dutch people can use the app for free or with reimbursement illustrates that broad insurer coverage is achievable, though it took well over a decade to get there.
Screenpoint Medical from Nijmegen is working on a comparable model for breast cancer screening. Its software supports radiologists in analysing mammograms. The company raised a Series B of €27 million in 2023 and focuses on earlier detection within existing screening programmes.
Digital guidance inside and outside the hospital
Caro Health (Amsterdam, founded 2019, €6 million seed funding in 2024) offers digital patient guidance in more than thirty hospitals. The software accompanies patients before and after treatment, with the aim of reducing unnecessary contact moments. Ancora Health from Groningen (founded 2019, €9 million seed) focuses on digital care, prevention and remote recovery via an AI platform.
Pacmed (Amsterdam, founded 2014, €24 million Series A in 2021) operates at the other end of the care spectrum: its platform optimises ICU capacity and patient outcomes in hospitals. Although this concerns secondary care, better ICU planning also has an effect on patient flow from primary care.
Regarding reimbursement for digital guidance, health insurers can make arrangements for reimbursing digital self-management tools and digital treatment modalities under the Zorgvernieuwing e-health performance category. In practice, this varies per insurer and per year, which creates an uncertain business case for startups.
Sensors and robots in elderly care
Sensara (Rotterdam, founded 2013, €9 million Series A) installs smart sensors in the homes of elderly people and in care homes to monitor health and safety without the use of cameras. Momo Medical (Delft, founded 2017, €6.5 million Series A) uses AI to predict when residents are about to get out of bed, enabling care staff to respond more effectively and reducing the number of routine rounds they need to make.
Zorgenmetsara (Eindhoven, founded 2019) is developing a robotic assistant that the company says can relieve care workers of up to three hours of work per day. The company received €390,000 through the European Regional Development Fund and is therefore at an earlier stage than the other players.
Remote care in home nursing can be reimbursed under the Health Insurance Act (Zorgverzekeringswet), provided the client has an indication for district nursing or personal care. Care organisations can claim up to 6.5 additional hours per client per month under code 1062. Whether sensor or robot solutions fall under these codes depends on the specific application and the agreements reached with the insurer.
Certification as a gateway
For virtually all of the companies mentioned, certification is a prerequisite for seriously entering the healthcare market. The European MDR regulation, which replaces the old MDD, sets stricter requirements for clinical evidence and quality systems. SkinVision complies with ISO 13485 and ISO 14971. Aiosyn (Nijmegen, founded 2021, €4.4 million Series A), which develops AI software for pathology diagnostics and cancer care, must also go through this process.
Zorginstituut Nederland and the Nederlandse Zorgautoriteit assess whether digital care qualifies for reimbursement. That process requires clinical evidence, a clear description of the service, and a willingness on the part of insurers to enter into agreements. For young companies with limited resources, this process is both costly and time-consuming.
The combination of MDR certification, clinical validation studies and insurer negotiations explains why it takes many of these startups years before their product is deployed on a structural basis. SkinVision took more than ten years to achieve broad coverage. That is not an exception in this sector.
For other founders in Dutch health technology, this pattern confirms that the go-to-market in healthcare is fundamentally different from other markets. Investing early in clinical validation and regulatory expertise appears to be a prerequisite, not an afterthought. Investors and policymakers looking to strengthen this ecosystem may want to take this into account when designing support programmes and procurement policies.