FDA Approves 'Bionic Eye' for Retinitis Pigmentosa Patients
FDA-approved implanted device to improve vision loss due to advanced retinitis pigmentosa.
The device uses a combination of electrodes in the retinal that receive wireless transmissions from a specialized video camera mounted on a pair of glasses to enable adults who have lost most or all of their vision to detect light and dark in the environment.
Clinical studies reviewed by the FDA showed the device helped otherwise blind subjects perform simple tasks such as matching gray-toned socks or detecting street curbs, with 19 of 30 subjects experiencing no adverse side effects. However, 11 participants experienced serious side effects including erosion of the conjunctiva, retinal detachment and hypotony, according to the report.
More Articles on Medical Devices:FDA Issues Device Quality Concern Notice to Hospira
Dr. D. Kevin Lester Performs First US Knee Replacements With NavioPFS
Hamilton Medical Issues Alert for Anesthesia Ventilator Software Problems
© Copyright ASC COMMUNICATIONS 2014. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.
To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.
- Baltimore Washington Eye Center adds Alcon CENTURION Vision System
- MRidium IV infusion pump system resumes U.S. distribution
- CMS announces new ICD-10 end-to-end testing opportunity for providers
- TiGenix submits Phase III Cx601 trial design to FDA for approval
- FDA approves new hepatitis C treatment drug