All compatible C-arm fluoroscope machines must meet the following requirements:
Please refer to the protocol video in the Video Hub.
4DMedical software solution analyzes cinefluorography images and a CT. A CT is needed to overlay the cinefluorographic images. Our patented software combines both and transforms the data to a 4-dimensional (3D plus time = 4D) representation allowing a unique quantification of regional ventilation. Only one prior CT is needed.
The FDA indication for use is to quantify ventilation of pulmonary tissue for use in adult patients. E.g. asthma, COPD, Cystic Fibrosis, Lung Transplant, etc.
No. XV LVAS requires REC approval to operate. (find out more here http://www.eurecnet.org/index.html). In the USA, the FDA indication for use is in adult-only patient population.
‘For a patient with an existing thoracic CT scan on file; the radiation dose is approximately 3% the dose of a thoracic CT. The subject device can use a previously acquired CT and therefore the effective radiation dose is significantly less than both of the predicate devices providing a considerable benefit to the patient.’
4DMedical has integrated Laurel Bridge Software into the lung function imaging analysis workflow. Laurel Bridge Software solutions automate a seamless cloud-based exchange of HIPAA-compliant, de-identified patient medical images and ensures the re-identification and delivery of XV Technology LVAS results into
the radiologist’s clinical workflow.
Laurel Bridge is a leading provider of medical imaging workflow solutions that enables healthcare providers, teleradiology service providers and OEM device manufacturers to orchestrate complex medical imaging workflows. For the last 30 years, Laurel Bridge Software has been providing healthcare organizations (2,000 installations in 30 countries) with enterprise imaging workflow solutions for image
routing, prior exam fetching, migration, and modality worklist management.
Laurel Bridge Software is an established, well-known company with a familiar presence amongst its customers. Because of its breadth of solutions, the organization supports HIPPA and standard compliant security, encryption and data anonymization while being vendor neutral and is easily customizable to meet workflow needs. For further information visit www.laurelbridge.com.
Once a contract is executed, it takes less than a week for Laurel Bridge to fully remotely install a system for your Institution.
Please complete the Expression of Interest (EOI) form on the bottom page of the virtual exhibit.
Please see XV LVAS Introduction video for an overview of the 4DMedical imaging workflow. This workflow can be fully automated from the point the imaging technician sends the report to the PACS.
4DMedical offers the XV LVAS Ventilation Report, an FDA cleared device. 4DMedical is also developing two additional products being, (i) Ventilation Perfusion – VQ (Perfusion) and (ii) Contrast Free Pulmonary Angiography – CFPA (Vasculature).
4DMedical has a dedicated offer to Pharmaceutical R&D departments. Please see the 4DMedical Pharmaceutical Offer video contained in the Video Hub.
Pricing starts at USD $200 per report with additional discounts based on hospital (or hospital network) volume.
No. CE clearance is anticipated to be obtained in 2021. XV Technology requires REC approval to operate in the EU. (find out more here http://www.eurecnet.org/index.html)
Yes, there are a variety of possibilities to implement at VA facilities in the USA.
Simply use the Chat Function to ask any other questions you may have.