FDA accepts new medical device harnessing AI to detect diabetic retinopathy
The US Food and Drug Administration has accepted the marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.
Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. It is the most common cause of vision loss among more than 30mn Americans living with diabetes and is the leading cause of vision impairment and blindness among working-age adults.
“Early detection of retinopathy is an important part of managing care for millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% do not see their eye doctor on a yearly basis,” said Malvina Eydelman, M.D., Director of the Division of Ophthalmic, Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health.
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“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
The device, IDx-DR, is a software program that uses an artificial intelligence algorithm to analyse images of the eye taken with retinal camera, Topcon NW400. A doctor uploads the digital images of the patient’s retinas to a cloud server on which IDx-DR software is installed.
If images are of sufficient quality, the software provides the doctor with one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or (2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.” If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.
IDx-DR is the first device authorised for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which importantly, makes it usable by health care providers who may not normally be involved in eye care.
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.”