United States - English - NLM (National Library of Medicine)

puretek corporation - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin cream is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of this product in the treatment of other disorders have not been established. the product should not be used if there is hypersensitivity to any of the ingredients. sunscreen (avobenzone 2.5%) sunscreen (octinoxate 3%) sunscreen (octisalate 3%) sunscreen (titanium dioxide 1.25%) ■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see directions), decreases the risk of cancer and early skin aging caused by the sun.

Australia - English - Department of Health (Therapeutic Goods Administration)

telemedc pty ltd - 58713 - automated retinopathy analysis system application software - the dr grading software is intended to screen and grade diabetic retinopathy (dr) in patients/general population through colour fundus retinal images. the dr grader is indicated for use by health care providers to automatically detect and grade diabetic retinopathy in patients who have been diagnosed with diabetes and screen those who have not yet been diagnosed with diabetes.

Australia - English - Department of Health (Therapeutic Goods Administration)

arif systems - 58713 - automated retinopathy analysis system application software - the software tool ipredict, will automatically screen individuals at risk of developing diabetic retinopathy (dr), age-related macular degeneration (amd), and glaucoma in the primary care and other clinical settings. an individual software application program or group of programs is used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. the software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. a basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. it may also be used in an off-the-shelf desktop, laptop, or tablet computer.

Australia - English - Department of Health (Therapeutic Goods Administration)

telemedc pty ltd - 58713 - automated retinopathy analysis system application software - the dr grading is intended to screen and grade diabetic retinopathy (dr) in patients/general population through retinal images. the dr grading outcomes are intended to be subsequently verified and certified by an eye specialist before forwarding to the primary health care professional

Australia - English - Department of Health (Therapeutic Goods Administration)

retscanner pty ltd - 58713 - automated retinopathy analysis system application software - automated machine learning screening system application software intended to analyze images and classify the images based on the presence of suspicous patterns in the image that could be lesions typical from pathologies such as diabetic retinopathy. the technology receives colour fundus images as input and outputs a label saying if the image has lesions or not (and from the images, infers a positive or negative result for the patient).

Australia - English - Department of Health (Therapeutic Goods Administration)

healthcare unlimited pty limited - 58713 - automated retinopathy analysis system application software - the product analyzes the medical images of the patient using deep neural network and deep learning/machine learning. the product applies artificial intelligence algorithms to detect the presence of diabetic retinopathy.

Australia - English - Department of Health (Therapeutic Goods Administration)

eyetelligence pty ltd - 58713 - automated retinopathy analysis system application software - the eyetelligence system is intended to screen and grade diabetic retinopathy (dr), cataract, aged related macular degeneration (amd) and glaucoma in patients/consumers through retinal images. the eyetelligence system outcomes are intended to be subsequently verified and certified by a qualified medical/eye care professional who will make a clinical decision based on a range of inputs not limited to eyetelligence outcomes.

Australia - English - Department of Health (Therapeutic Goods Administration)

rqsolutions medical devices distribution support - 58713 - automated retinopathy analysis system application software - the medical device is a software product that analyses an input color fundus image for signs of age-related macular degeneration, diabetic retinopathy and glaucoma. the software produces several outputs which includes scores for amd and dr that are indicative of the severity of amd and dr; a score for glaucoma that indicates the likelihood of presence of glaucoma; and heat maps indicating possible abnormal areas. taking the outputs of retcad into account, the intended user can decide if the patient should be referred for additional testing.

European Union - English - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - ophthalmologicals - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv)

European Union - English - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - ophthalmologicals - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv)