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FDA approved

NICO.LAB ready to revolutionize U.S. stroke care following FDA clearance

By | News, Press Release

The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB’s artificial intelligence powered solution in stroke care. StrokeViewer enables physicians to provide every stroke patient with the right treatment, as fast as possible. Two million brain cells die every minute until blood flow is restored (Saver, 2006), starting treatment earlier can make the difference between recovery or life-long disability.

StrokeViewer LVOThis week the FDA approved a 510k application (FDA K200873) for StrokeViewer LVO, an artificial intelligence algorithm for fast triaging of stroke patients. StrokeViewer LVO detects image characteristics associated with a Large Vessel Occlusion (LVO) and alerts physicians. The FDA application was supported by a multi center clinical study where the performance of the algorithm was retrospectively evaluated in 384 patients from multiple US stroke centers. An expert panel assessed the data to identify LVOs (ICA, M1 and M2) and comparison with the algorithm showed results that exceeded the performance goal.

StrokeViewer was developed by the Dutch medtech company NICO.LAB. The cloud-based solution uses artificial intelligence to support physicians in the emergency stroke setting. The FDA-cleared LVO algorithm is embedded in a cloud-based system that sends a notification to the medical specialists involved just minutes after a stroke patient arrives in the hospital. The physicians are able to use their smartphones, in the hospital but also at home, to inspect the CT images in a web viewer and diagnose a stroke.

Merel Boers CEO & Founder“Medical specialists are under enormous pressure to make fast decisions day and night, but it’s not easy. Complicated assessment and interhospital communication sadly make life difficult for physicians motivated to treat stroke victims effectively” – said Merel Boers, CEO and co-founder of NICO.LAB. “With our first FDA clearance we are now able to show U.S. physicians how impactful the combination of human and artificial intelligence is. And yes, more will follow as we are fully committed to unlocking the full healthcare potential for every patient.”

StrokeViewer is currently in use in Australia and Europe where it has proven to reduce the time from hospital arrival to start treatment for patients with acute stroke, leading to reduced patient disability in the short-term and more clot removal treatments performed.

Stroke is a leading cause for serious long-term disability in the United States. The economic burden of stroke exceeds an astonishing $100 billion per annum (Girotra, Lekoubou et al., 2020). Stroke incidence and associated costs are rising drastically due to an ageing population and increasing unhealthy lifestyle. NICO.LAB is dedicated to playing a crucial role in reducing these stroke related costs and improving quality of life of patients by combining human and artificial intelligence to revolutionize emergency stroke care.

FDA approvalStrokeViewer consists of a comprehensive set of tools to support the entire stroke workflow. StrokeViewer LVO is the first with FDA approval. Local availability of StrokeViewer functionality is subject to applicable CE marking, TGA and FDA approval (actual status on www.nico-lab.com).

References:
Saver, 2006 – “Time is brain—quantified.” Stroke 37.1 (2006): 263-266
FDA K200873 – StrokeViewer LVO is approved as HALO under FDA submission number K200873
Girotra, Lekoubou et al. 2020 – “A contemporary and comprehensive analysis of the costs of stroke in the United States” Journal of Neurological Sciences, volume 410, 116643

Nico.lab is selected for the Techleap.nl Rise Program

By | News, Press Release

AMSTERDAM, 28 MAY 2020

Nico.lab has been selected for Techleap.nl Rise program, the showcase for future unicorns

The Netherlands, under the Techleap.nl-program, has officially launched Techleap.nl Rise. With this ambitious programme, Techleap.nl and top entrepreneurs like Pieter van der Does (Adyen), Ali Niknam (bunq), Steven Schuurman (Elastic), Chris Hall (Bynder), Michiel Muller (Picnic) and Gillian Tans (Booking.com) are helping the most promising scale-ups in the Netherlands to grow faster internationally. Scale-ups participating in the first batch along with Nico.lab are: Easee, Floryn, LTO Network, Mapiq, Online Payment Platform, Polarsteps, Quicargo, Starred and Wizenoze.

As part of the programme, we will be put on the international map with corporates, investors and media. We are encouraged in groups of ten to fifteen participants to also learn from each other about the challenges of scaling up a company.  We will receive support and feedback from top Dutch entrepreneurs who share their own insights and lessons learned with the new batch of promising scale-ups. Every quarter Techleap.nl Rise will help a new group of entrepreneurs.

Merel Boers, CEO Nico.lab: ‘We are so thrilled to have been selected as one of the highest potential scale-ups in the Netherlands. We are looking forward to cooperating with the other talented entrepreneurs to learn and grow together, taking the Dutch tech world to the next level!’

Two unicorns a year, best ecosystem in Europe
The aim of Techleap.nl Rise is to support the emergence and development of world champions in the technology sector, to become less dependent on technological solutions from other countries and to create a climate in which two unicorns per year can ‘rise’. By 2023, Techleap.nl Rise wants to have supported 250 promising scale-ups. The insights from the program will also be shared to further improve the tech-ecosystem in the Netherlands and to define bottlenecks and solutions for the growth challenges of scale-ups.

Strict selection
The criteria to participate are strict: a scale-up qualifies for the program if they meet the following criteria: currently €10M+ is being raised in a funding round or they are preparing to raise it with their next round (which has probably already been funded €1-5M); an annual turnover in excess of €1 million; more than 10 FTEs employed; at least 50% annual growth and a clear understanding of the product/service and the market they serve. 

Constantijn van Oranje, Special Envoy Techleap.nl : “With Techleap.nl Rise we want to create more Dutch technology companies that can measure themselves against the best internationally. We have found the best entrepreneurs in the business willing to help our most promising scale-ups with honest hard and constructive feedback. By learning from each other’s experiences and connecting them to the right parties, we create an innovative climate in which the tech leaders of tomorrow can rise above themselves.” 

Gillian Tans, Chairwomen Booking.com : “The Techleap.nl Rise program allows me to give back the insights of my own scaleup journey with Booking.com to today’s most promising companies.”

Koen Droste, CEO Polarsteps: “Techleap.nl Rise is important to us because it paves the way for us to the international tech scene: from investors, to media and techtalent. We expect the program to have a real impact on the growth of our company through the connections we can make.” 

Read more about the selected scale-ups and the program here.

Nico.lab join forces with expert partners to fight Covid-19

By | News, Press Release

Nico.lab is proud to announce the establishment of the ICOVAI consortium; a collaboration between science, clinical and technology experts. We believe AI can relieve some of the overwhelming pressure on medical staff and together will develop a valuable not-for-profit solution. The goal of ICOVAI is to support medical staff during the crisis by developing and deploying an AI solution for triaging and risk stratification of COVID-19 patients.

We see an increasingly clear case for using chest CT scans to assess the severity of COVID-19 and the likelihood of patients requiring ICU care. We recognised that our understanding of the clinical workflow and experience in developing AI for CT coupled with that of consortium partners can be leveraged to increase the speed and accuracy of these assessments during this critical time. 

About ICOVAI:

  • ICOVAI is a not-for-profit initiative aiming to leverage experience and knowledge of consortium partners in  the fight against Covid-19. 
  • ICOVAI aims for fast development and implementation of an AI-powered solution to help healthcare professionals deal with assessing the severity of COVID-19.

Deployment at scale in clinical practice

Beyond development, ICOVAI is well-equipped to validate and deploy the AI solution at scale across hospitals in Europe, aiming for these key results: 

  • European adoption and safe use of AI in COVID-19 triaging and risk stratification 
  • Increase speed and accuracy in COVID-19 triaging and risk stratification 
  • Reduce workload in COVID-19 imaging workflow

The COVID-19 pandemic is endangering people and healthcare systems across the world. AI has the potential to guide rapid decisions on patient care, risk management and hospital planning. To make a contribution during this crisis, we need to act quickly and work together.

More info on ICOVAI here→ https://www.icovai.org/

WE NEED TO FIGHT COVID-19 TOGETHER.

Press Release: Better treatment of stroke using artificial intelligence and blockchain

By | News, Press Release

Amsterdam, 21th March 2018  Every year about 50,000 people in the Netherlands are affected by a stroke. About 10,000 of these patients die and this number continues to increase. In order to reduce mortality, it is crucial to start the right treatment as soon as possible. Innovative technologies such as artificial intelligence and blockchain can help improve the outcome of a stroke.

For this purpose, Nico.lab, a spin-off of the Academisch Medisch Centrum (AMC) and developer of medical artificial intelligence, in collaboration with Tymlez, a provider of enterprise blockchain technology, have joined forces. Both companies are starting a pilot this month with a number of hospitals for superior treatment of strokes. They received funding from the Ministry of Economic Affairs and climate, which underlines the importance of these innovations.

Stroke is the leading cause of death after heart diseases and cancer in our country.

Rapid treatment crucial
Every hour that doctors are going to treat earlier, the number of patients who will recover without major problems increases by 15%. This means not only a significant improvement in the quality of life, but also a decrease in the economic cost of stroke. These amounts are currently more than EUR 1.7 billion per annum for the Netherlands.

A doctor can only choose the right treatment if there is a lot known about the problem in the patient’s brain, as with an infarction, the exact location of any blood clot. Viewing the scans by a doctor is however complex and time-consuming. Moreover, in practice, the analysis of the brain scan does not always lead to the correct diagnosis, which can have major consequences for the treatment and how the patient eventually recovers from the stroke. This also leads to unnecessarily high costs.

Artificial intelligence: fast and precise
The use of artificial intelligence in the treatment of stroke is an important improvement. These algorithms are, by applying the latest computer technology, not only fast, but also precise due to their learning ability. Nico.lab also makes the artificial intelligence solution available via the cloud, allowing hospitals to use it in a low-threshold way. These savings are estimated at over € 200 million on an annual basis, in light of the current costs of € 1.7 billion per year.

Because the computer for this artificial intelligence is not in their own hospital, the scans are encrypted and sent to Nico.lab via an internet connection at lightning speed. After analysis, the specialist receives the notification that he can log in to view the scans and the result itself. It is not important whether the neurologist is in a hospital or in a foreign hotel room while visiting a major medical conference or enjoying a day off at home.

Blockchain technology guarantees patient data confidentiality.
Naturally, confidentiality must be guaranteed when exchanging patient data. Because this is an exchange of privacy-sensitive data in a chain of medical professionals, the use of blockchain technology is the solution. Where many blockchains are known for cryptocurrency such as Bitcoin, the power of blockchain is security in data exchange. Tymlez ensures that all parts in the chain of people and machines are connected to the system via an unbreakable and safe process. The brain scans are then uniquely coded, so that they can only be shared with chain participants who are authorized to do so. The security of patient data is fully guaranteed in this way.

Note for editors:
For more information please contact:
Robert A. Kuipers, CEO Nico.lab: 06 1258 6631.

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