Is clearcanvas planning on obtaining FDA approval for the US market?

Unfortunately, this would be a requirement for this product if it plans to be widely adopted.

Would clearcanvas prefer that each developing company that uses the source code obtain their own FDA approval?

Thanks

So how is the FDA approval going?

bump :)

Thanks for your interest in this...We are definitely committed to gaining FDA approval and are currently in the process of doing so. The application process is taking longer than we anticipated so it's unlikely that we would have approval in time for RSNA. However, we are hoping to obtain FDA approval by the end of the year.

Jonathan

 I don't really want to raise everyone's hopes and expectations too high, because the FDA clearance process can always throw you a curve ball when you least expect it. However, since we have given everyone a rough time frame before, I think it's only right that we give you an update.

We have been working very closely with our 510(k) reviewer, and should have all the paper work filed in the next few days. We don't expect there to be any more issues, so we should be getting our clearance roughly 30 days after that. So, it'd be fair to say that I'm hoping to get our clearance letter by the beginning of February.

Regards,

Clinton

Niksavel I'm looking to implement a disaster contingency and recovery system, as I'm in the UK the CE status of parts of Clearcanvas does have some bearing. If it gets FDA approval then I'm happy that it will meet or exceed the relevant CE levels and I will deploy it.
The PACS end should have CE IIa BUT as with all these things until it has been tested in a european members legal system or the euro courts then it is open to interpretation. As long as you or your organisation are happy to hold the liability for your instances use then go for it.
The reporting workstation end is a slightly different CE class (CE 1) but essentially the same applies.
As I'm deploying this in the Breast Screening world there are more rules that will have to be taken into account.
However as my use is as a disater contingency system and there is no way I can budget for a fully approved commercial system ( £30-40K plus another £36K for a dedicated Mammo WS with CAD) I'm inclined to take the line that if the images displayed are on a suitable monitor (5K GS) and they pass a critical QA inspection then this is going to be what we will use.
Rules like this are OK until they actually impede enabling sensible decisions when you just have to apply a modicum of pragmatism.

Hello all:

I'm happy to update everyone that pending the review of our responses to a request from the FDA for a few additional pieces of information, we will be cleared. Can't commit on timelines, because we all know (now) that it's pretty unpredictable.

Re: CE marking

We have begun the required work to get CE marking for the ClearCanvas commercial products. Unfortunately, there is a steep learning curve, and having our ISO 13485 certification only gets us part of the way there.

My position is a bit different from Nick's regarding the classification. We are marketing the entire suite of products as the ClearCanvas RIS/PACS system. Thus, the classification of the entire system takes on the most serious safety classification of its constituent components. In our case, that would be Class IIb.

The reasoning for IIb, is that the ImageServer and Workstation will be dealing with CT and MR images, and thus would be considered a device that influences or drives the use of the scanning modalities themselves. In these cases, the software needs to take on the classification of those other devices (the modalities), meaning that our RIS/PACS becomes a Class IIb device.

Fortunately, ClearCanvas has always taken medical device development very seriously and our processes have been designed to take a very conservative approach, i.e. do as much as we reasonably can to ensure safety of the device. We do have to make some modifications to our systems so that it'll be easier for an auditor to audit us for compliance, so there's definitely more work to do there before we CE mark. However, it's a goal that's within reach.

Clinton

That is really good news on the FDA front for ClearCanvas, that you are also looking at CE certification is from a European perspective even better, but then I'll admit to a degree of bias being on the other side of the Atlantic!
I've installed a few instances of CC mainly out of personal and professional curiosity and have always been impressed by the product itself and the obvious care that has gone into its production. Your move to 13485 , 501 and possibly CE accreditation speaks volumes on the teams desire to provide a safe experience for users.

I'm sure that you are aware of the position in the UK Clinton, a national program put PACS and RIS into a huge number of sites supported by regional suppliers. The contracts and central funding for this program expire in 2012/13 and hospital groups are looking for cost effective replacements.
The RIS instances have been configured in clusters so that wide swathes of the UK can access each others records which is going to be tough to replace as it works so well in patient care. A product looking for any penetration in the UK really needs that sort of capability. I can't imagine that this isn't possible with the CC RIS.
The PACS instances deployed by the national program are more isolated with limited remote (from the hospital groupings and within the clusters) image access. The main competitors are those already in place as a part of this national program (GE, Siemens, Agfa et al) but a lot of consideration is being given to other smaller vendors now and we are seeing smaller suppliers capturing specialist areas of the market like Breast Screening and being given serious consideration in the more main stream NHS hospital market. Having a CE certified product for the PACS market here would add a further choice in the UK and Europe, a commercially supported package is even more attractive.

As to my perception of the needs in a service contingency plan and post disaster recovery I see the context of use being slightly different. The PACS element becomes, or at least can justifiably described as, an intermediary device only and with a primary role of a flexibly configurable routing device between modalities and workstation.
This is one of the reasons that CC looks to be the package to fill that role, I can apply rule sets to handle differing contingencies and circumstances on the fly. That it also retains a copy of those images is a bonus giving me a further level of redundancy for the copy retained on a dedicated work station. It's what I need and what I want to fill a need in what have become very financially challenging times.

Apologies for rambling a bit off topic!!

Hi all,

Just wanted to let you all know that our FDA 510k clearance finally came through! Our newly released Clinical Edition of ClearCanvas Workstation is an officially FDA cleared product.

N.