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Corsano Health in RTL News
This technology should save thousands of lives: recognise cardiac arrests and sound an alarm. Corsano Health CardioWatch in Radboudumc Cardiac Arrest Clinical Trial.
Smartwatch should save thousands of lives: recognize cardiac arrests and sound an alarm
Corsano Health CardioWatch in Radboudumc Cardiac Arrest Clinical Trial
Every year, approximately 17,000 Dutch people suffer a cardiac arrest outside the hospital. 7000 to 8000 this happens without someone being there to alert the emergency services. Radboudumc in Nijmegen and Corsano Health are now working on a special smartwatch. A first version of a wristband is already available at Radboudumc, says cardiologist and lead researcher Judith Bonnes. If patients have to undergo an operation in which the heart is stopped – for example when an ICD, a kind of pacemaker – is placed, they are given the band. “That measures exactly what happens in a cardiac arrest. We try to collect as much data as possible to properly program the wristband,” she explains.
Corsano Health Wins Call Heart Foundation
We are proud to announce that the Dutch Heart Foundation awarded Corsano Health a development project to recognize cardiac arrest and alert emergency services. Survival of Out-of-Hospital Cardiac Arrest (OHCA) depends on early recognition of Cardiac Arrest and initiation of Cardiopulmonary Resuscitation (CPR). To provide help as early as possible, we will develop a version of CardioWatch 287 bracelets that will signal a cardiac arrest and enable emergency services.
Medica 2021 Stand D24 Hall 12
Corsano Health is launching its CardioWatch 287 at MEDICA 2021.
Corsano’s CardioWatch 287 accuracy of a state-of-the-art bracelet has been validated in six third party clinical investigations. The independent validations of Corsano Health’s CardioWatch 287 is important evidence to prove accurate measurement of five vital parameters. Moreover, Corsano offers access to raw PPG and ACC data for further analysis to academic researchers and contract research organizations. Corsano’s non-invasive ergonomic wearables deliver medically validate data with superior patient compliance. Additionally, patient satisfaction surveys conducted at the closure of the studies cite convenience and ease to use of the CardioWatch 287 devices.
Please visit us at Stand D24 Hall 12.
Corsano Health Receives EU-MDR Certification
Notified Body DARE!! Services B.V. declares that it has audited the quality assurance system in accordance with MDR Annex IX and that the relevant provisions of the Regulation 2017/745 dated May 5, 2017 concerning Medical Devices are fulfilled. The validity of the certificate is three years and includes the surveillance obligations of Annex IX, section 3. CardioWatch 287 is covered by the certificate and may bear the CE marking using the Notified Body number “1912”.
Medical Certification
We are happy to announce that Corsano Health B.V. is medically certified complying with Annex IX (MDR) and EN-ISO 13485 standards.
Accuracy of heartbeat detection
Elsevier’s Journal of Electrocardiology just published a validation study that showed that the Corsano 287 CardioWatch/Bracelet with PPG-technology can determine HR and RR-intervals with high accuracy in a cardiovascular patient population, with high quality output in different subgroups, especially when combined with a signal quality indicator.
Movie
Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring. See the movie here to learn more about the capabilities of our bracelet, the technology and the efficient ways to retrieve data.
CardioWatch 287-1 is in the final stages to be CE medically certified and we have started the process for FDA Clearance. Bracelets are now available as investigative device.
AFNET Clinical Trial
Corsano shipped 2000 CardioWatches 287-1 as Investigative Devices for the AFNET 9 study. The Smart in OAC – AFNET 9 study is testing whether unknown atrial fibrillation (AF) can be detected via an app and a monitoring bracelet. It is the objective to detect AF at an early stage using modern technologies. The number of newly detected, previously unknown episodes of atrial fibrillation and the effectivity of the program will be evaluated.
Corsano Trials
Corsano Trials iOS and Android Applications are now available in Beta! We ship CardioWatch 287-1 as an Investigative Device and accept orders for our Evaluation Package.
Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 8 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.
Researchers can set vital parameters and the sample frequency from the Settings Menu. Date is saved to Corsano’s Health Cloud and available for easy download in CSV, JSON and PDF format. Alternatively, data can be accesed via our API.
Patient ID
The silicon strap of the Corsano CardioWatch Bracelet has a rescessed area to attach a sticker with Patient information. We are also in discussion with hospitals to add RFID identification
Ergonomics
Corsano CardioWatch Bracelets have an ergonomic design to stimulate 24/7 continous wear, particularly important for Hospital-to-Home Use Cases
Pre-Production
We have started to assemble 5000 units of the Corsano CardioWatch Bracelet, to be used in various Clinical and Implementation Trials
Magnetic Charger
Latest versions of the Corsano CardioWatch Bracelet have an easy to use magnetic charger solution with green and orange LEDs to indicate charging and pairing status
Straps
Corsano is studying various silicon straps, including 3M Coated Tissue Tape to attach patient information.
CardioWatch Bracelet
The first 3D printed Corsano Bracelet were received.
CAD-CAM
Corsano’s Bracelet has been developed with state of the art CAD-CAM software.
Design
Initial design was created after extensive discussions with physicians and stakeholders.
