States. Currently, the differences between FDA regulations and ISO 13485 are less than 5 per cent, with plans in place to reduce this further. Te FDA plans to roll out its revised quality system regulations by April. ‘Next April there will be a deadline that the ISO 13485:2016 version needs to be implemented at medical device manufacturers,’ said Behringer. ‘Tis means from April on, these manufactures will have the need for a dedicated supplier management system. From April onwards there will be a lot more discussion about supplying ISO 13485-compliant products.’ According to Basler, the Med Ace is the first


‘standard’ camera on the market that is produced, distributed and serviced under ISO 13485:2016 certification. While Behringer expects other camera


manufacturers to follow suit in producing ISO 13485-compliant products, he believes this will be very challenging to achieve. ‘For medium-


From April onwards there will be a lot more


discussion about supplying ISO 13485-compliant products


sized camera manufacturers, especially, this will not be a very easy process, because the ISO certification is very complex, and a very high- quality level will be needed, before it can even be implemented.’ A range of new feature sets that target medical


and life science applications have been developed for the Med Ace, each of which take advantage of the cameras’ Sony Pregius or On Semiconductor Python CMOS sensors. Tese include a low light imaging feature set, to capture weak light signals from fluorescence microscopy, and a colour calibration, which will benefit medical imaging in many clinical diagnostic applications that rely on exact colour information. Ophthalmology, for example, will benefit from the Med Ace’s high colour accuracy, according to Behringer.


Switching to CMOS Te increasing prominence of DNA sequencing has opened up new fields of research, such as cell therapy, synthetic biology and personalised medicine, into which imaging and machine vision distributor Multipix – a supplier of Basler’s Med Ace cameras – has been selling into, according to Simon Hickman, the firm’s director. He explained that CMOS sensors from Sony and


www.imveurope.com @imveurope


On Semiconductor that offer a high dynamic range, exceptional low-light sensitivity, and very good quantum efficiency, are now driving a lot of these applications, and that they have been increasingly taking over from the cooled CCD technology still used by a lot of researcher customers. ‘Noise reduction is a key factor in life sciences.


Lots of applications in the field involve looking at very small levels of fluorescence, where high sensitivity and low noise are the key parameters,’ Hickman said. ‘Tese new sensors also offer very low dark current noise in addition to low-read noise – which itself is less than 10 per cent of what would be expected from an equivalent CCD sensor. Tis enables these new CMOS sensors to be used in applications where you would have previously required a cooled CCD sensor, the setup for which is very expensive and considerably larger.’ According to Behringer, the CCD cameras still


used in many research and high-end applications are in the range of €10,000, whereas cameras such as the Med Ace, based on new CMOS technology, can be found starting at around €600. Tese cameras can also be offered in a much smaller physical footprint – the Med Ace is around 29mm3 in volume and weighs around 80g – because they don’t require a cooling system, which CCD-based cameras typically do. Behringer expects CMOS technology will become even more powerful in the future, with upcoming sensors from Sony and other manufacturers, and that over the next two years the high-end market of cooled CCD technology will be replaced by very compact cameras using CMOS sensors. One firm that has been reaping the benefits of


advances in CMOS technology is Huron Digital Pathology, which incorporates area scan CMOS RGB cameras from Teledyne Dalsa into its scanning systems, which are used to image glass biopsy slides containing a patient’s tissue samples. ‘In the past, line scan cameras were commonly


used in many whole slide scanning systems in digital pathology,’ said Patrick Myles, CEO of Huron. ‘By standardising on area scan cameras, we were not only able to increase the scan speed significantly – by being able to do a single pass versus three passes with line scan – but we were also able increase the perceived quality of the image being produced. We can image a 15mm2 area at 20 times magnification in less than a minute, and can resolve features as small as 0.2µm.’ Myles also said this adoption of area scan cameras into applications that have traditionally used line scanning is accelerating thanks to advances in CMOS technology.


NEw


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THE FUTURE DEPENDS ON OPTICS


Feb. 5 - 7, 2019 | Booth 1141 Visit us at


UK: +44 (0) 1904 788600


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