The breakthrough status from QuantalX was granted for the diagnosis of normal pressure hydrocephalus patients and the prediction of their response to VPS. Their product, Delphi-MD, has received the breakthrough device designation from the regulatory authorities. This designation recognises the innovative nature of the device and its potential to offer significant advantages in treating a specific medical condition.
Delphi-MD is described as a novel medical device that aims to revolutionise the field of diagnostics. It utilises advanced technology and algorithms to analyse patient samples and provide rapid, accurate results. The device has shown promising potential in detecting a specific medical condition, and the breakthrough device designation signifies recognition of its transformative impact on patient care.
In a recent article by MedicalDevice-Network.com, they highlight the potential benefits of Delphi-MD, including its ability to provide quicker and more precise diagnostic information, leading to improved patient outcomes and more efficient healthcare delivery. It mentions that the breakthrough status will enable QuantalX to accelerate the development and commercialization of Delphi MD, ultimately benefiting patients and healthcare providers.
According to the article, regulatory authorities grant the breakthrough device designation to speed up the development and review process of cutting-edge medical devices that address unmet medical needs. It provides QuantalX with additional support and resources, such as increased interaction with regulatory agencies, to facilitate the device's regulatory approval and eventual market entry.
Read the full article at the Medical Device Network here: medicaldevice-network.com