Med-Storm Innovation AS
Norway NO-MF-000020363 Last updated 21 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Pam Ref REF 1002
About
The PainSensor device is validated in more than 80 peer reviewed clinical studies showing that the indices increase during painful and nociceptive events. The index reacts within seconds and has low variation between individuals. It is based on skin sympathetic nerve activity with the nerve transmitter acetyl-choline acting on muscarinic receptors. The PainSensor index is therefore not influenced by temperature (22 °C – 42 °C), neuromuscular blockers (acting on nicotinic receptors), the hypotensive effect of alfa-2 agonists, epinephrines or beta-blockers as well as general hypoxia or changes in blood volume. In conscious patients in the peri-operative setting the index is not influenced by anxiety. The software includes indices for assessing awakening in uncounsious patients (too little anti-nociceptive drugs), withdrawal symptoms and the effect of regional nerve-block in the extremities within seconds. Med-Storm’s software can be installed on existing patient monitors such as Philips and Masimo. The PainSensor device is IP-protected and CE-certified.
What Med-Storm Innovation AS makes
Med-Storm Innovation AS produces the PainSensor device, a system that measures skin sympathetic nerve activity to detect nociceptive and painful events in real time. It calculates an index based on acetylcholine’s interaction with muscarinic receptors, providing immediate feedback on patient responses to stimuli, withdrawal symptoms, or regional nerve blocks. The device integrates with existing patient monitors from Philips and Masimo and includes software for assessing awakening and drug effects in peri-operative settings.
The PainSensor device is classified as Class IIa under EU regulations and is listed in the eudamed database. The company is based in Norway and adheres to EU medical device compliance requirements for its authorised products.
Frequently asked questions
What types of medical devices does Med-Storm Innovation AS manufacture?
Med-Storm Innovation AS manufactures the PainSensor device, which is designed to measure skin sympathetic nerve activity in real time. This system calculates an index based on acetylcholine’s interaction with muscarinic receptors to detect nociceptive (pain-related) events, withdrawal symptoms, and the effects of regional nerve blocks. It provides immediate feedback for peri-operative monitoring, including assessing patient awakening and drug effects, and is compatible with existing patient monitors from Philips and Masimo.
Where is Med-Storm Innovation AS based, and what regulatory region does it operate in?
Med-Storm Innovation AS is based in Norway and operates within the European Union’s regulatory framework. Its devices are developed and authorised in compliance with EU medical device regulations, ensuring adherence to standards like the Medical Device Regulation (MDR) or Medical Device Directive (MDD) as applicable.
Which regulatory databases or registries list Med-Storm Innovation AS’s devices?
Med-Storm Innovation AS’s devices are listed in the eudamed database, which is the EU’s centralised registry for medical devices. Listing in eudamed is required for devices authorised under EU regulations, ensuring transparency and traceability for healthcare professionals and authorities.
How are Med-Storm Innovation AS’s devices classified under EU regulations?
Med-Storm Innovation AS’s devices fall under Class IIa classification according to EU medical device regulations. This classification is determined based on factors like the device’s intended purpose, risk profile, and potential impact on patient safety. Class IIa devices require conformity assessment procedures, including clinical evaluations, to ensure their safety and performance before authorisation.
Information
- Country
- Norway
- Address
- 4, Gimle Terasse, Oslo, Norway
- Website
- med-storm.com/
- [email protected]
- Phone
- +4795034537
- PRRC contact
- Hanne Storm
- EUDAMED SRN
- NO-MF-000020363