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Devices Ophthalmology FDA

 News Release - June 4, 2014

CenterVue Announces FDA Clearance of Next Generation Macular Integrity Assessment (MAIA)

State-of-the-art microperimetry monitors the course of retinal diseases and treatment efficacy

SAN JOSE, Calif.--(Healthcare Sales & Marketing Network)--CenterVue, Inc. (www.centervue.com), a leader in the design and manufacture of highly automated medical devices for the diagnosis and management of ocular pathologies, today announced FDA 510(k) clearance has been granted for the company's next generation Macular Integrity Assessment (MAIA).

MAIA offers the latest advances in scanning laser ophthalmoscopy (SLO) confocal microperimetry. Microperimetry is a technology that allows concurrent analysis of structural and functional aspects of the retina. It is a powerful tool that is able to detect, describe, and follow-up pathologies affecting the macular area, including those that represent the leading causes of blindness. MAIA is intended for measuring macular sensitivity, fixation stability and the focus of the fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

Microperimetry, with its combined structure-function analysis, represents in clinical practice an essential tool for:
  • Deriving the correct diagnostic decision on a variety of retinal diseases
  • Monitoring progression of retinal pathologies
  • Monitoring treatment efficacy
  • Assessing macular function prior to cataract surgery
  • Describing fixation characteristics prior to laser treatment
  • Examining patients with unexplained vision loss
The additional functions and improved features of the newly enhanced version of the MAIA yield faster examinations. The differences between the redesigned MAIA and its predecessor include:
  • External redesign which is more ergonomic and features a smaller footprint
  • A more powerful PC
  • New automatic alignment
  • Dynamic multifixation
CenterVue, Inc. CEO Cliff Wright, OD, states, "FDA clearance of the MAIA represents significant opportunity for eye care professionals. Through the device's combined structure-function analysis, this device is an essential tool for a variety of retinal diseases. From diagnosis, to monitoring progression of both retinal pathologies, and treatment efficacy, the MAIA is the first easy-to-use Microperimetry and represents a significant advance in macular functional analysis."

ABOUT CENTERVUE, INC.

CenterVue, Inc. is a privately held company, headquartered in Padova, Italy, with a US subsidiary located in San Jose, CA. CenterVue develops diagnostic systems for the early detection of sight-threatening pathologies, such as Diabetic Retinopathy and Macular Degeneration. The company's goal is to reduce preventable blindness in diabetic and aging patients. CenterVue's solutions integrate seamlessly with state-of-the-art telemedicine packages and with CenterVue's proprietary telemedicine platform, the Eye Knowledge Network. In addition to MAIA, the company's product portfolio includes the DRS fundus non-mydriatic camera, a fully automated device that captures digital images of the central retina used for screening of diabetic retinopathy. With nearly 3000 installations worldwide, CenterVue's technologies have helped doctors worldwide with the implementation of global screening programs for early detection of ocular pathologies and vision disorders.


Source: CenterVue

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