IPredict

iHealthScreen Inc. is Awarded a US Patent on Glaucoma Detection, Which Is Based on AI and Color Fundus Imaging

Retrieved on: 
Tuesday, April 9, 2024
Physical Therapy, Technology, Managed Care, Health, Optical, Health Technology, Medical Devices, Photography, Software, Artificial Intelligence, Telemedicine, Virtual Medicine, Research, Diagnosis, Glaucoma, CE, Patient, Hospital, ARVO, IPredict, Paratriathlon, TGA, AMD, Diabetic retinopathy

The early screening and detection of glaucoma can potentially help prevent the progression to severe glaucoma and save millions of people from blindness.

Key Points: 
  • The early screening and detection of glaucoma can potentially help prevent the progression to severe glaucoma and save millions of people from blindness.
  • The entire test which includes color retinal imaging and the automated AI-based glaucoma report generation can easily and reliably be completed within 5 minutes.
  • Glaucoma detection offers an overall accuracy of 94.3% for identifying an individual with glaucoma.
  • iPredict’s glaucoma detection model can be used as follows:
    iPredict-glaucoma report will produce which will indicate referable (i.e., early to severe glaucoma) or non-referable glaucoma (not glaucoma).

iHealthScreen Inc. Announces UK Medicines and Healthcare Products Regulatory Agency (MHRA) Certification and registration for iPredict™ - Automated AI System for Early Diagnosis of DR, AMD, and Glaucoma

Retrieved on: 
Tuesday, December 5, 2023
General Health, Health, Technology, Optical, Artificial Intelligence, IPredict, DR, Glaucoma, Patient, Independent Healthcare Providers Network, Diabetes, AMD, Vance DeGeneres, Neuroscience, Risk, Hospital, Diabetic retinopathy, Paratriathlon, Medical device, Medicine, Ophthalmology

iPredict™ AI Eye Screening System provides fully automated diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results.

Key Points: 
  • iPredict™ AI Eye Screening System provides fully automated diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results.
  • The entire test can easily and reliably be completed within 5 minutes.
  • iPredict-AMD can detect referable AMD such as intermediate to late AMD and non-referable AMD such as early or none.
  • iPredict is indicated for use by healthcare providers in clinics, hospitals, or other healthcare facilities to automatically detect DR, AMD, and glaucoma suspects.

iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool – An Automated AI-based Software as a Medical Device for Early Diagnosis of Age-Related Macular Degeneration (AMD)

Retrieved on: 
Tuesday, May 23, 2023
Software, Optical, Telemedicine, Virtual Medicine, Medical Devices, Technology, Artificial Intelligence, Health Technology, Photography, Audio, Video, FDA, Health, Physical Therapy, Glaucoma, Independent Healthcare Providers Network, Late, AAO, Diabetes, AMD, Class, Stroke, American Academy, Neuroscience, DR, IPredict, Paratriathlon, Mount Sinai, Icahn School of Medicine at Mount Sinai, Certification, Hospital, Patient, Risk, Annual general meeting, IHS, Diabetic retinopathy, AI, Panel discussion, HIPAA, Television, Pharmaceutical industry, Medical device, Medical imaging, Ophthalmology, Medicine

iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results.

Key Points: 
  • iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results.
  • iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity and specificity.
  • The completed pivotal trial of the device demonstrated that iPredict-AMD achieved excellent accuracy with a sensitivity of 86.86% and a specificity of 94.13%.
  • iHS received CE certification, and Australian and Abu Dhabi Health approvals (Class II med device) for AMD, DR and glaucoma screening.

A Transformational Year: ImaginAb expands Pipeline to include Radiopharmaceutical Therapies, enters Multiple Partnerships, and Drives Forward Development of Investigational CD8 ImmunoPET Agent

Retrieved on: 
Tuesday, October 4, 2022
CD8, Society for Immunotherapy of Cancer, RPT, Prognosis, GMA, Society, GMP, AstraZeneca, Boehringer Ingelheim, Medication, Technology, BOT, Research, IND, Biologics license application, Memorial Sloan Kettering Cancer Center, Immunotherapy, Cave rescue, MSKCC, Atezolizumab, Patient, Papillary renal cell carcinoma, COVID-19, Phase II, Roche, CRO, PET, University of California, Davis, Partnership, BLA, Pfizer, Inclusion body myositis, SITC, United Kingdom, IPredict, Radiopharmaceutical, University, IBM, Melanoma, Data analysis, CMO, Fine chemical, Pharmaceutical industry, Medical imaging, Biotechnology

ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years.

Key Points: 
  • ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years.
  • In August 2021, ImaginAb completed its Phase I IBM study showing utility of CD8 ImmunoPET to detect disease pathology in Inclusion Body Myositis (IBM) patients.
  • ImaginAb formally launched its Phase IIb 'iPREDICT' study to measure CD8 ImmunoPET imaging predictivity and prognosis, building on the data from its promising Phase IIa 'BOT' study.
  • These GMA agreements include:
    PharmaLogic, the fastest growing radiopharmaceutical manufacturer in North America, to manufacture and distribute CD8 ImmunoPET for ImaginAb.

A Transformational Year: ImaginAb expands Pipeline to include Radiopharmaceutical Therapies, enters Multiple Partnerships, and Drives Forward Development of Investigational CD8 ImmunoPET Agent

Retrieved on: 
Tuesday, October 4, 2022
CD8, Society for Immunotherapy of Cancer, RPT, Prognosis, GMA, Society, GMP, AstraZeneca, Boehringer Ingelheim, Medication, Technology, BOT, Research, IND, Biologics license application, Memorial Sloan Kettering Cancer Center, Immunotherapy, Cave rescue, MSKCC, Atezolizumab, Patient, Papillary renal cell carcinoma, COVID-19, Phase II, Roche, CRO, PET, University of California, Davis, Partnership, BLA, Pfizer, Inclusion body myositis, SITC, United Kingdom, IPredict, Radiopharmaceutical, University, IBM, Melanoma, Data analysis, CMO, Fine chemical, Pharmaceutical industry, Medical imaging, Biotechnology

ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years.

Key Points: 
  • ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years.
  • In August 2021, ImaginAb completed its Phase I IBM study showing utility of CD8 ImmunoPET to detect disease pathology in Inclusion Body Myositis (IBM) patients.
  • ImaginAb formally launched its Phase IIb 'iPREDICT' study to measure CD8 ImmunoPET imaging predictivity and prognosis, building on the data from its promising Phase IIa 'BOT' study.
  • These GMA agreements include:
    PharmaLogic, the fastest growing radiopharmaceutical manufacturer in North America, to manufacture and distribute CD8 ImmunoPET for ImaginAb.

iHealthScreen Completed Prospective Trial of AI-Based Tool for Age-Related Macular Degeneration (AMD) Screening and Submitting the Results to FDA for 510K Clearance

Retrieved on: 
Monday, August 8, 2022
Apps, Applications, Technology, FDA, Clinical Trials, Health Technology, Telemedicine, Virtual Medicine, Biotechnology, Health, Optical, Artificial Intelligence, FDA, Interview, Diabetic retinopathy, Risk, Icahn School of Medicine at Mount Sinai, NIH, Diagnosis, AI, Glaucoma, Clinical trial, Incidence, New York Eye and Ear Infirmary, Stroke, DR, Severe cognitive impairment, AMD, IPredict, HIPAA, Ophthalmology, SBIR, Adult, Adoption, Medical device, Medicine

The initial clinical trial results show adequate accuracy for FDA clearance.

Key Points: 
  • The initial clinical trial results show adequate accuracy for FDA clearance.
  • The study was funded by NIH SBIR grants and completed with the collaboration of the New York Eye and Ear Infirmary at Mount Sinai.
  • AMD, with no early signs or symptoms, is a leading cause of adult blindness in the developed world.
  • iHealthScreen is in the final stage of submitting the results to FDA for 510K clearance.

iHealthScreen Inc. is Awarded US Patent on Late Age-related Macular Degeneration (AMD) Prediction Model, which is based on AI and Color Fundus Imaging

Retrieved on: 
Thursday, July 7, 2022
Software, Optical, Health, Diabetes, Artificial Intelligence, Medical Devices, Hospitals, Technology, Diagnosis, Independent Healthcare Providers Network, Glaucoma, AMD, Risk, CE, IPredict, Severe cognitive impairment, Diabetic retinopathy, Health, Hospital, Cryptocurrency

The prediction model can potentially help prevent late AMD and save millions of people from blindness.

Key Points: 
  • The prediction model can potentially help prevent late AMD and save millions of people from blindness.
  • The prediction model offers an overall accuracy of 89.61% for identifying an individual at risk of progression to late AMD.
  • iPredicts late AMD prediction model can be used as follows:
    iPredict-AMD can detect referable AMD such as intermediate to late AMD and non-referable AMD such as early or none.
  • Once referable AMD is detected, iPredict late AMD prediction model will be utilized and compute the probability score for late AMD.

ImaginAb and Roche have entered a clinical trial supply agreement for provision of atezolizumab (Tecentriq®)1 to Non-Small Cell Lung Cancer Patients Enrolled in ImaginAb's iPREDICT Phase IIb Study

Retrieved on: 
Wednesday, June 8, 2022
MSD, IPredict, Immunotherapy, PET, TILS, Renal cell carcinoma, Atezolizumab, RPT, TRC, Non-small-cell lung carcinoma, Roche, Physician, CD8, Zirconium, Patient, Cancer, Phase, PET/CT, Heart, Positron, NSCLC, Melanoma, Fine chemical, Medical imaging, Vaccine, Pharmaceutical industry, Pharma, Merck

The study builds on the data from the company's Phase IIa 'BOT' (Baseline On/Treatment) Trial which completed enrolment in November 2021.

Key Points: 
  • The study builds on the data from the company's Phase IIa 'BOT' (Baseline On/Treatment) Trial which completed enrolment in November 2021.
  • Cancer types targeted in the Phase IIb study include Melanoma, Merkel Cell, Renal Cell Carcinoma, NSCLC and other selected solid tumors.
  • "We are delighted that Roche is supporting our iPREDICT trial by providing atezolizumab (Tecentriq) for patients with NSCLC who are enrolled in our study.
  • This has informed how we have designed the 'iPREDICT' trial, with ImaginAb setting "response prediction" at the heart of the trial.

ImaginAb and Roche have entered a clinical trial supply agreement for provision of atezolizumab (Tecentriq®)1 to Non-Small Cell Lung Cancer Patients Enrolled in ImaginAb's iPREDICT Phase IIb Study

Retrieved on: 
Wednesday, June 8, 2022
MSD, IPredict, Immunotherapy, PET, TILS, Renal cell carcinoma, Atezolizumab, RPT, TRC, Non-small-cell lung carcinoma, Roche, Physician, CD8, Zirconium, Patient, Cancer, Phase, PET/CT, Heart, Positron, NSCLC, Melanoma, Fine chemical, Medical imaging, Vaccine, Pharmaceutical industry, Pharma, Merck

The study builds on the data from the company's Phase IIa 'BOT' (Baseline On/Treatment) Trial which completed enrolment in November 2021.

Key Points: 
  • The study builds on the data from the company's Phase IIa 'BOT' (Baseline On/Treatment) Trial which completed enrolment in November 2021.
  • Cancer types targeted in the Phase IIb study include Melanoma, Merkel Cell, Renal Cell Carcinoma, NSCLC and other selected solid tumors.
  • "We are delighted that Roche is supporting our iPREDICT trial by providing atezolizumab (Tecentriq) for patients with NSCLC who are enrolled in our study.
  • This has informed how we have designed the 'iPREDICT' trial, with ImaginAb setting "response prediction" at the heart of the trial.

iHealthScreen Inc. Announces Australian Health (TGA) Approval for iPredictTM Automated AI System for Early Diagnosis of Diabetic Retinopathy (DR), Age-Related Macular degeneration (AMD), and Glaucoma Suspect

Retrieved on: 
Monday, April 18, 2022
Diabetes, Optical, Health, Medical Devices, CEO, Independent Healthcare Providers Network, Icahn School of Medicine at Mount Sinai, Risk, Diabetes, Hospital, AMD, Vance DeGeneres, Patient, Severe cognitive impairment, Glaucoma, Technology, Neuroscience, Mount Sinai, Diabetic retinopathy, Certification, DR, IPredict, Medical device, Ophthalmology, Medicine

iPredictTM AI Eye Screening System provides fully automated diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results.

Key Points: 
  • iPredictTM AI Eye Screening System provides fully automated diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma suspect screening, including retinal imaging, and immediate reporting of actionable results.
  • iPredicts CE certification indications for use as follows:
    iPredict-DR can detect more than mild DR or vision threatening DR such as severe non-Proliferative DR, proliferative and diabetic macular EDEMA.
  • iPredict-AMD can detect referable AMD such as intermediate to late AMD and non-referable AMD such as early or none.
  • iPredict is indicated for use by healthcare providers in clinics, hospitals or other healthcare facilities to automatically detect DR, AMD and glaucoma suspect.