Hi Coads, I have a very vague recollection WP saying we would get reimbursement for the US trial/s only, under a Category B IDE clinical trial. Category B refers to "non-experimental" devices, as opposed to Category A which refers to "experimental" devices. I assume this means our device is not considered a completely novel or experimental device (i.e. we're using components/methods like catheters and cages that have already been proven to work by others). Reimbursement for non-experimental devices but not experimental devices seems counterintuitive to me but thats how I read it below? I dont think Breakthrough Status is necessary for reimbursement but I guess it wouldnt hurt....
https://www.massdevice.com/how-to-secure-medicare-coverage-for-your-ide-clinical-trial/
https://www.fda.gov/media/98578/download
Ann: Proposal to Negotiate Non-Binding Letter of Intent - Merger, page-135
-
- There are more pages in this discussion • 7 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add AVR (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$15.68 |
Change
0.680(4.53%) |
Mkt cap ! $331.4M | |||
| Open | High | Low | Value | Volume |
| $14.90 | $15.75 | $14.85 | $431.9K | 28.2K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 200 | $15.21 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $15.95 | 300 | 1 |
View Market Depth
| Last trade - 16.10pm 16/08/2024 (20 minute delay) ? |
| AVR (ASX) Chart |