What Does an FDA Breakthrough Designation Mean?

Neuralert Technologies was recently accepted into the FDA Breakthrough Devices Program. The program is intended for medical devices that provide effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development while staying consistent with the FDA’s mission to protect and promote public health.

Medical devices eligible for Breakthrough Devices Approval

Devices eligible for this program must meet certain criteria:

1) The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.

2) The device meets at least one of the following:

  • It represents breakthrough technology
  • No approved or cleared alternatives exist
  • It offers significant advantages over existing alternatives
  • Device availability is in the best interest of the patients

Neuralert fulfills these criteria. Neuralert is a breakthrough technology that has been proven to alert hospital staff to a possible stroke dramatically faster than current hospital protocols do, thus improving outcomes and saving lives. For instance, while studies show that 50% of all in-hospital strokes are not detected within 4.5 hours, Neuralert detects 80% of ischemic strokes in less than one hour.

Benefits of Breakthrough Device designation

A Breakthrough Device designation conveys fast track benefits to the device, to speed the approval process and bring the product to a broader patient base as soon as possible. Benefits include:

  • “Sprint” discussions with the FDA on novel issues related to the device, with the goal of reaching a mutual agreement with the agency within a set time period.
  • Priority review or rolling review, moving to the front of the queue and receiving additional review resources
  • Timely advice to, and interactive communication with, the sponsor of the device regarding development to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable
  • Assignment of a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
  • Involvement of senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review

This expedited program helps ensure that therapies for serious conditions are available as soon as it can be concluded that the therapies’ benefits justify their risks, taking into account the seriousness of the condition and the availability of alternative treatment.

Improving outcome of in-hospital strokes through Neuralert

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts to efficiently address topics as they arise during the premarket review phase, helping manufacturers to receive feedback from the FDA in a timely manner and to speed up the approval process.

Neuralert Stroke Detection System has proven itself to be an enormously effective method for detecting the possible presence of a stroke significantly faster than current hospital protocols. The Breakthrough Devices designation approval process will provide Neuralert with the FDA approval at a much faster rate than the usual approval method since our system is already developed and proven in the field. The FDA approval will allow us to help save more lives and improve the quality of life for millions of stroke victims every year.