Imaging

1. What fluoroscope machines models are suitable for imaging?

All compatible C-arm fluoroscope machines must meet the following requirements:

• Capability of capturing frame rates of 15fps or greater
• Stationary / not-mobile
• Rotation of at least +/- 72degrees from AP
• Automatic Exposure Rate Control (or equivalent) equipped
• A detector panel size of nominally 40 cm x 30 cm (W x H).

2. What is the imaging protocol?

Please refer to the protocol video in the Video Hub.

3. Why do I need to have a CT on file when ordering an XV Lung Ventilation Analysis Software (LVAS)?

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.

4. What types of patients can I order a XV LVAS?

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.

5. Can I order an XV LVAS for a 9-year-old patient with cystic fibrosis?

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.

6. What is the radiation dose of XV LVAS Scan?

‘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.’

IT

7. How is 4DMedical connected to the hospital?

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.

8. Who is Laurel Bridge?

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.

9. What are Laurel Bridge’s credentials?

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.

10. How long does it take to get connected?

Once a contract is executed, it takes less than a week for Laurel Bridge to fully remotely install a system for your Institution.remotely connect a hospital to 4DMedical.

11. How do I get 4DMedical installed in my hospital?

Please complete the Expression of Interest (EOI) form on the bottom page of the virtual exhibit.

Operational

12. What is the 4DMedical report workflow?

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.

13. What other products do 4DMedical offer?

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).

14. What value does 4DMedical bring to BioPharma Discovery and Development?

4DMedical has a dedicated offer to Pharmaceutical R&D departments. Please see the 4DMedical Pharmaceutical Offer video contained in the Video Hub.

15. How do I become a 4DMedical research collaborator?

Please email us at collaborations@4dmedical.com

Financial

16. What does a XV LVAS Ventilation Report cost in the USA?

Pricing starts at USD $200 per report with additional discounts based on hospital (or hospital network) volume.

Other

17. Is XV LVAS available in Veteran’s Affairs System in the USA?

Yes, there are a variety of possibilities to implement at VA facilities in the USA.

18. Any other questions not listed that you may have?

Simply use the Chat Function to ask any other questions you may have.

19. Is this product CE cleared for clinical use in the EU?

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)