According to Cancer Research UK, over 350,000 people are diagnosed with cancer in the UK each year. It has also been found that up to three times as many people will survive cancer if diagnosed early...
In 2017, Hamamatsu Photonics supplied the national Cancer Vanguard programme with four whole slide imaging scanners and became a part of the Cellular Digital Pathology (CDP) project. The National Cancer Vanguard programme is an established delivery programme in partnership with University College London Hospital, Royal Marsden and Greater Manchester to test and fast track innovation in cancer care.
The aim of the CDP project was to win the ‘hearts and minds’ of the pathology community by demonstrating how digital pathology, if integrated in the future, will add value, both in terms of improvement of clinical outcomes and patient care.
The project aimed to overcome a number of challenges faced by the pathology community. The first related to the increasing workload of pathologists due to the growing number of cases they need to review. In addition, the project also aimed to enhance communication between pathologists by improving the process of obtaining second opinions through digital pathology and therefore reducing delays in diagnosis.
"We want to find out how our colleagues working in cellular pathology feel about working with the new technology, which has the potential to bring significant benefits to patients," said Dr Motta.
In response to overcoming these challenges Hamamatsu Photonics proposed to implement a range of their digital slide scanners including the NanoZoomerⓇ S60 Digital slide scanner, NanoZoomer S210 Digital slide scanner and NanoZoomer-XR. These scanners were placed in five institutions across Greater Manchester where they became part of an end-to-end service capable of safely scanning, storing and the reporting of 1,700 cases to a clinical pathology community over a three month period. From the 1,700 targeted cases to be digitally reported over the period of the project, 1,471 requested and 2,028 specimens were reviewed and validated.
The project was concluded a success with pathologists stating the solution worked and that increased workloads could be partly managed by improving slide flow across pathology departments using digital pathology as an enabler, facilitating a more collaborative and flexible regional working environment.
On behalf of Hamamatsu Photonics, the project provided an opportunity to demonstrate the capabilities digital pathology can offer to clinical institutions when implemented. To be able to offer a solution to those working within healthcare was a significant achievement for our company and we look forward to the future possibilities our technology can offer.
The matrix sheet shows the NanoZoomerⓇ IVD series registered as medical system in each region.
USA | EU/EEA | UK | Swizerland | China | Canada | Taiwan | Republic of Korea | Japan | Turkey | Israel | |
---|---|---|---|---|---|---|---|---|---|---|---|
NanoZoomer S20MD | C16300-21MDEU | C16300-21MDEU | C16300-21MDEU | C16300-31MDCA | C16300-11MDJ | C16300-21MDEU | |||||
NanoZoomer S60v2MD | C16600-21MDEU | C16600-21MDEU | C16600-21MDEU | C16600-21MDEU | C16600-21MDEU | ||||||
NanoZoomer S360MD | C13220-01MD | C13220-21MDEU | C13220-21MDEU | C13220-21MDEU | C13220-61MDK | C13220-11MDJ | C13220-21MDEU | C13220-21MDEU | |||
NanoZoomer S60 | C13210-01 | ||||||||||
NanoZoomer S360 | C13220-01 | C13220-31 | C13220-01 | ||||||||
NanoZoomer S210 | C13239-01 | ||||||||||
NanoZoomer-SQ |
Important Notice
In the USA, the C13220-01MD NanoZoomer S360MD Slide scanner system can be used for primary diagnosis in the following validated FDA-cleared displays:
・JVC JD-C240BN01A *The display is FDA cleared for use with the NanoZoomer S360MD.
・BARCO MDPC-8127 *The display itself is FDA cleared.
In Europe, the following products are regulatory compliant for IVDR (EU), UKCA (UK) and IvDO (CH) for in vitro diagnostic use:
C13220-21MDEU NanoZoomer S360MD Slide scanner system, C16600-21MDEU NanoZoomer S60v2MD Slide scanner system and C16300-21MDEU NanoZoomer S20MD Slide scanner system.
In China, the following products are registered for in vitro diagnostic use:
C13220-01 NanoZoomer S360, C13239-01 NanoZoomer S210, C13210-01 NanoZoomer S60 and C13140-01 NanoZoomer-SQ.
In Canada, C13220-31 NanoZoomer S360 and C16300-31MDCA NanoZoomer S20MD Slide scanner system have Medical Device License.
In Taiwan, C13220-01 NanoZoomer S360 is registered as medical device.
In Korea, C13220-61MDK NanoZoomer S360MD Slide scanner system is registered as in vitro diagnostic medical device.
In Japan, C13220-11MDJ NanoZoomer S360MD Slide scanner system and C16300-11MDJ NanoZoomer S20MD Slide scanner system are approved as medical devices.
In Turkey, C13220-21MDEU NanoZoomer S360MD Slide scanner system, C16600-21MDEU NanoZoomer S60v2MD Slide scanner system and C16300-21MDEU NanoZoomer S20MD Slide scanner system are registered as medical devices.
In Israel, C13220-21MDEU NanoZoomer S360MD Slide scanner system and C16600-21MDEU NanoZoomer S60v2MD Slide scanner system are registered as medical devices.
For other countries, the NanoZoomer series are for research use only and not permitted to use for clinical diagnostic purpose.
The NanoZoomer line-up and medical device regulatory status varies across countries. For more information, please contact your local Hamamatsu sales representative.
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