The Future of NIMBLE Diagnostics
NIMBLE Diagnostics has displayed fantastic results in various examinations analyzing the stent status in both bench tests and animal labs. These tests were used to demonstrate how NIMBLE’s technology can detect stent malfunctions within the human body at the earliest known time. This was a demonstration of innovation, modern technology, and the potential to change the outlook of millions of patients suffering from heart disease.
NIMBLE Diagnostics’ technology is not only non-invasive, effective, and fast, it has been proven to detect a variety of stent malfunctions. NIMBLE Diagnostics has had fantastic results in a multitude of detections. Those include restenosis, blockages, fractures, and collapses. All of these malfunctions can lead to life-threatening complications, including causing the patient to have a myocardial infarction or heart attack, stroke, or even death.
As of now, NIMBLE Diagnostics is ready for clinical validation. The next steps that the NIMBLE team will be working on include finishing a prototype, completing the human clinical trial, and obtaining a CE certification as well as a quality and safety system assessment. The human clinical trial will verify the results that have already been seen in current assessments. These include the effectiveness and efficacy of the NIMBLE Diagnostics technology to change the outlook of patients suffering from the number one cause of death at present — cardiovascular disease.
All of NIMBLE’s research and development activities have resulted in a system that accurately measures and quantifies non-invasive stent malfunction. However, further steps are needed before we can offer our technology to clinicians.
Next Steps for NIMBLE Diagnostics
Complete the prototype of the medical device and pre-series manufacture of the prototypes that will be used during the human clinical trial.
Validate NIMBLE Diagnostics’ system in a human clinical trial to evaluate the effectiveness and efficacy of the technology.
Regulatory, Safety, Quality, and Compliance:
Undergo a conformity assessment procedure for the CE certification of NIMBLE, including the assessment of the Quality Management System (QMS) and of the technical documentation. In the US, a 510(k)-application submission will be addressed.