Hitachi has gained FDA clearance for its RGPT systems
Hitachi and Hokkaido University have announced that it has recently received US Food & Drug Administration (FDA) 510(k) clearance for the commercialisation of “Real Time Image Gating System for Proton Beam Therapy Systems” (RGPT)
The system will allow patients in the US to be treated with cutting-edge motion management, together with its advanced Spot Scanning irradiation technology.
Proton therapy is a type of radiation used to treat cancer in which protons from a hydrogen atom are extracted and accelerated up to 60 times the speed of light. Its energy is concentrated directly on the tumour while avoiding radiation dose to the surrounding healthy tissues.
Patients experience no pain during treatment and the procedure has very few side effects compared with that of traditional radiotherapy.
In most cases, patients can continue with their normal daily activities while undergoing treatment, thus maintaining their quality of life. For these reasons, demand for this type of cutting-edge irradiation therapy continues to grow around the world.
In 2010, a grant under the Funding Program for World-Leading Innovative R&D on Science and Technology (the “FIRST Program”) sponsored by the Japanese government was awarded to the project between Hitachi and Hokkaido University to jointly develop an advanced technology to treat moving targets with proton beam therapy.
By 2014, RGPT and the advanced irradiation technology of Spot Scanning were integrated into Hitachi’s system for the first time. Spot Scanning irradiation technology does not scatter proton beams as with conventional proton beam therapy. Rather, it repeatedly turns a narrow proton beam on and off at high speed as it progressively changes location to irradiate entire tumor volumes. Protons can be aimed with high precision according to the targeted tumors, even those with complex shapes, while minimizing the impact on nearby healthy tissue.
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Conventional motion management simply tracks the surface of the patient’s body and irradiates with the proton beam based on a predetermined timing. By tracking the location of gold markers placed near the tumor with X-rays, RGPT is able to irradiate the targeted tumor while in motion and with greater accuracy with a proton beam.
Hitachi received clearance from Japan’s Pharmaceuticals Medical Device Administration for its Proton Beam Therapy system equipped with RGPT in 2014. Jointly developed with Hokkaido University Hospital and its Clinical Research and Medical Innovation Center, RGPT has been used in approximately 70% of patients treated in the past three years at the hospital.
RGPT has been highly acclaimed and has been awarded the Imperial Invention Prize of 2017 – an honour bestowed by the Japan Institute of Invention and Innovation for the most outstanding inventions.
Dr. Hiroki Shirato, Director of Hokkaido University Hospital’s Research Group with which Hitachi conducted the joint development, stated, “Hokkaido University has been developing motion tracking technology in the field of X-ray therapy.
By combining this technology with Spot Scanning technology, the accurate irradiation of tumors, including those attached to large organs in motion which are difficult to irradiate with X-rays, will be possible and will lead to greater adaptation. I am very pleased that this innovation for highly precise irradiation will become broadly available around the world.”
With this FDA clearance, Hitachi will move forward with plans to install RGPT at facilities under construction in the United States.
NHS care homes are better than private, report finds
A new survey has found that 60% of people with parents in NHS care homes believe the quality of care has improved, compared to just 49% of respondents with parents in private care facilities.
The survey was conducted by Kepler Vision Technologies, an AI-driven company formed at the University of Amsterdam. It was carried out among UK adults with parents over the age of 75.
Respondents cited more capable care staff and better monitoring systems as being the main reasons for improvement.
However those who do not have parents in assisted living facilities had a different viewpoint - in this case only 35% of respondents believe that NHS facilities are improving, compared to 32% who believe it is only improving in the private sector.
Only 18% of people whose parents live with them or independently believe care home staff are able to look after residents to a good standard.
Kepler Vision say this difference in opinion is due to perceived budget cuts and financial pressures, with 67% of people commenting that a lack of funding has had a negative effect on care in both NHS and private care facilities.
Other key findings of the survey include:
* Out of those who say quality has declined in care homes, 69% say the NHS is dealing with budget cuts and increased financial pressure, while 65% also said that the private system is dealing with these pressures too
* 55% said that they or their parent have money saved specifically to pay for their future care
* 35% said the idea of their parent in a care home makes them feel frightened, although 32% say it makes them feel secure
* 52% are worried about their parent catching COVID
* 47% are worried about their parent being lonely
* 46% are concerned they could fall over alone
The announcement of this research follows the UK government's decision to delay presenting its social care budget till the autumn.
Commenting on the research, Dr Harro Stokman, CEO of Kepler Vision Technologies said: “While it is good to see that people recognise the importance of staff and face-to-face interaction in elderly care, the huge gap in opinion between those with parents in care and those without shows that there are unfair negative perceptions around the residential care space.
"More can and should be done by care homes to give people the confidence that their relatives will receive the very best care - by highlighting the excellent work of staff and how well they are able to monitor resident’s needs with easy-to-use technology.”