AIM Filed for FDA Clearance
AIM reached another milestone as Inventeur LLC applied for FDA clearance. Once approved, AIM will be ready for commercialization.
AIM reached another milestone as Inventeur LLC applied for FDA clearance. Once approved, AIM will be ready for commercialization.
With an increase in the worldwide growth of NORA cases, Inventeur LLC has filed for patent protection in Japan and Brazil. The new filings are in addition to the previously filed patents in the US, Canada, Australia, the EU, and India. AIM continues to expand its global footprint in the international healthcare sector.
AIM recently underwent testing by third-party labs required by the FDA for 510(k) filing. AIM passed the biocompatibility testing, and the gas flow test results came back better than expected, making AIM a strong contender for the NORA (Non-Operating Room Anesthesia) patient population. The startup is in the process of filing for FDA clearance.
In addition to patents issued in the United States, international patents have been filed in Canada, Australia, the European Union, and India. International patent protection in these countries expands AIM’s global footprint and ensures AIM’s utilization and growth in the international healthcare sector. The global minimally invasive market is expected to grow by 9.1% to…
The AIM device concept was one of the few devices selected and invited for a presentation at the Annual Meeting of the Society for Technology in Anesthesia (a global conference of the anesthesia innovators) in Austin, Texas, 2020.
The pre-market prototype of the AIM device was recently tested under simulated patient conditions at a patient-simulation lab used to test airway devices, following GLP regulations and Reviewer Guidance for Premarket Notification Submissions. The results of the testing and the data collected, confirm that AIM’s oxygen delivery and capnography outperformed the commonly used mask device…
Patents US 10,252,018 B2 and US 10,987,476 B2 were issued by the US Patent Office.