Medical Informatics Corp. said it won 510(k) clearance from the FDA for its Sickbay clinical platform and patient monitor, patient alarm data and alarm data analytics dashboard applications.
SickBay and the associated applications aid in monitoring and managing alarms, the Houston, Texas-based company said.
The system provides near real-time viewing of alarms through a web browser, and tracking and analysis of alarms so custom alarm limits can be set for patients on an individual basis, the company said.
“FDA clearance of our Sickbay clinical platform and the 1st series of applications is a significant achievement for our team. This step forward validates our vision of helping transition data into action for stakeholders across an organization – making sure the right information gets to the right person at the right time. It positions Sickbay to be the enterprise platform to deliver active patient monitoring and patient-specific analytics solutions that can empower clinicians, reduce healthcare costs, and improve patient care to hospitals across the U.S.,” CEO Emma Fauss said in a press release.
Medical Informatics expects the software to be used in critical care environments with the most highly monitored patients, according to Xconomy.
T hecompany has raised $630,000 in seed funding, including $500,000 from the Texas Children’s Hospital, which the company has a joint development project with, according to Xconomy.
The company is reportedly working towards approval of additional applications for “critical events of deterioration”, such as predicting heart attacks or apnea events in advance, the company told Xconomy. The company hopes to submit the applications to the FDA next year.
The post Medical Informatics wins FDA nod for Sickbay system appeared first on MassDevice.
from MassDevice http://ift.tt/1S5BcAM
Cap comentari:
Publica un comentari a l'entrada