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Digital Health
Wellthy Therapeutics Secures FDA, HIPAA Certification for SaMD Platform
The platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR.
Michael Barbella, Managing Editor
07.17.23
Diagnostics
LumiThera Acquires MacuLogix, an AMD Diagnosis Firm
Company is also the developer of the wearable AdaptDX Pro dark adaptometer.
Sam Brusco, Associate Editor
07.26.22
Chronic Disease
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Patient Monitoring
Abbott, CamDiab, Ypsomed Partner on Automated Insulin Delivery
Combines FreeStyle Libre 3 CGM sensor with CamAPS FX mobile app and mylife YpsoPump.
Sam Brusco, Associate Editor
04.29.22
Osama Hamdy Joins Nemaura Medical's Advisory Board
New board member is an associate professor of medicine at Harvard Medical School.
Globe Newswire
01.03.22
Cardiovascular
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Diagnostics
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Digital Health
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Neurological
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Patient Monitoring
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Software & IT
Bayer Inks Deals with 11 Digital Health Startups
Eleven healthcare startup companies to be supported by Bayer’s “G4ADigital Health Partnerships program.”
Bayer
10.14.19
Pre-Pilot Trial From Ocutrx Vision Technologies Yields Promising Results for Patients With AMD
New Oculenz headset enhances functional vision for patients with severe age-related macular degeneration.
Ocutrx Vision Technologies
08.02.19
Contract Manufacturing
Glaukos Corporation to Acquire DOSE Medical Corporation
DOSE Medical will become a wholly owned subsidiary of Glaukos.
Business Wire
06.20.19
Implanted Drug ‘Reservoir’ Safely Reduces Injections for Macular Degeneration Patients
Implanting a medication reservoir in eyes lessens the need for injections and may reduce clinic visits to twice per year.
Johns Hopkins Medicine
06.14.19
Ocutrx Vision Technologies Unveils Oculenz AR Cellular with Eye-Tracking Glasses Design
The glasses are low-profile and more lightweight than the HoloLens 2.
Ocutrx Vision
04.09.19
MDR Insight: How to Strategize for CER Success
A sound plan for success can provide companies a competitive advantage and keep existing products on the market.
Online Exclusives
Scott Edwards, Managing Director, Solutions Delivery, Maetrics
12.18.18
Diagnostics
Notal Vision's Patient-Operated Home OCT System Granted Breakthrough Status
First-of-its-kind artificial intelligence-enabled technology for monitoring exudative age-related macular degeneration (AMD).
PR Newswire
12.04.18
Researchers Develop New Devices to Test Retinal Cells
The aim is to better understand the triggers of age-related macular degeneration (AMD), a degenerative eye disease.
Utah State University
10.25.18
Inotec AMD Receives Award from Frost & Sullivan
Company given the Global 2018 Product Leadership Award in Chronic Wound Care Management.
Inotec AMD Limited
07.11.18
Novartis to Spinoff Alcon
Alcon strategic review concludes 100 percent spinoff in best interest of shareholders and consistent with Novartis’ focus.
Novartis
07.02.18
Cardiovascular
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Diagnostics
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Patient Monitoring
FDA OKs Optovue's AngioAnalytics, the World’s First OCT Angiography Metrics
Aids in early detection and management of diseases causing progressive blindness.
Business Wire
06.11.18
Digital Health
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Software & IT
Ensuring a Successful Migration to Windows 10
The right moves protect validation, increase security, and enable a competitive edge.
Online Exclusives
Jeff Durst, Director of Product Management and Solutions Architect, Dedicated Computing
02.16.18
Pixium Vision Receives FDA Approval to Begin Human Clinical Study of Its PRIMA Sub-Retinal Implant
Study is designed to evaluate PRIMA in patients with Atrophic Dry Age-related Macular Degeneration.
Business Wire
01.30.18
Advancing Human Health Through Microelectronics
IMMS presents microelectronic solutions to cancer diagnosis, blindness at Medica 2017.
IMMS
11.13.17
Cardiovascular
Exhibitors
...
11.03.17
First Patient in the Nation Receives a Telescope Implant for Age-Related Macular Degeneration
Telescope implant for end-stage macular degeneration is FDA approved and available to patients 65 years and older.
Business Wire
10.13.17
AdvaMed and CAMDI Sign Innovation Cooperation Agreement
The agreement is designed to encourage and promote advanced medical technologies.
AdvaMed
09.26.17
RAMD 2017: The World Congress on Regulatory Affairs for Medical Devices
...
03.02.17
VisionCare to Initiate Clinical Study of Telescope Implant in Post-Cataract Patients
Telescope implant for end-stage macular degeneration is already FDA approved.
VisionCare Ophthalmic Technologies
01.13.17
Second Sight’s Argus II 'Bionic Eye' Receives Funding from UK Goverment
For the first time in the UK, the publicly-funded NHS system will fund blind patients with RP to receive treatment.
Business Wire
12.22.16
FDA Clears SalutarisMD's SMD-Sr90-DA Radionuclide Brachytherapy Source
The minimally invasive procedure can be performed in an outpatient setting in approximately 15 minutes.
Business Wire
12.20.16
Contract Manufacturing
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R&D & Design
Salutaris Medical Devices Achieves ISO 13485 Certification
Company achieves certification for the treatment of wet age-related macular degeneration.
Business Wire
11.09.16
Artificial Retinas: Promising Leads Toward Clearer Vision
The scientists were able to improve the properties of the interface between the prosthesis and retina
CNRS (Delegation Paris Michel-Ange)
08.25.16
Software & IT
Eyenuk Announces CE Mark and Commercial Launch of EyeArt 2.0
In a new study, EyeArt 2.0 demonstrated 91 percent sensitivity and 90.8 percent specificity.
Business Wire
06.30.16
Software & IT
Amadeus Invests in Inotec’s Advanced Woundcare Technology
Investment will support global distribution of Natrox.
Amadeus Capital Partners
05.17.16
Testing
First Ever Combination of Robotic and Biological Vision in Humans
Research involved the use of the ARGUS II electronic epiretinal prosthesis.
Association for Research in Vision and Ophthalmology
05.04.16
First Skin-to-Eye Stem Cell Transplant in Humans Successful
Patient suffered from advanced wet age-related macular degeneration that did not respond to current standard treatments.
Association for Research in Vision and Ophthalmology
05.04.16
Vital Art and Science Receives Patent for mVT Service Product
Device tracks changes caused by age-related macular degeneration.
11.06.15
Post-Market Obligations AMDD compliance would also entail more robust post-marketing requirements f
...
09.05.12
R&D & Design
Technical Documents for AMDD Registration The ASEAN directive includes requirements for common tech
...
09.05.12
Authorized Representation Mandatory Although the AMDD would create a single regulatory framework fo
...
09.05.12
Conformity Assessments Evaluating medical devices’ compliance with the AMDD would be accompli
...
09.05.12
Classification Under the AMDD Incorporating elements from the European Union’s Medical Device
...
09.05.12
Breaking News
Arterex Expands Leadership Team
Heart Rhythm 2024: Society Kicks Off 45th Annual Meeting in Boston
Wytech Industries Names Bill Gallucci as Chief Financial Officer
Study: AI-Driven Prediction Models Accurately Foretell Critical Care Patient Deterioration
Anumana Appoints Harry Palmin as Finance Chief
View Breaking News >
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May 2024
Partner Preference in Full-Service Medical Device Outsourcing
Spot Check: A Discussion of the In-Vitro Diagnostics Market
Innovative Iteration for Medical Device Design
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