Houston’s Medical Informatics Gets FDA Nod for Alert System Software
[Corrected 6/22/15, 11:13 am. See below.] Medical Informatics, a Houston healthcare IT company, has received FDA clearance to sell the first version of its healthcare data alert system, a major milestone as it works to bring its product to market.
The company is focusing on “alarm management,” with software that aggregates patient data in the hospital gathered from devices like heart rate monitors in real-time in order to alert healthcare providers to an impending issue, say, a heart attack.
“We’re working toward data transformation to provide more actionable information to clinicians rather than raw data,” says Chris Raff, Medical Informatics’ chief financial officer and chief operating officer.
The 510k clearance from the FDA allows the company to sell its technology to hospitals. Medical Informatics expects the software to be used in critical care environments with the most highly monitored patients, Raff says.
[An earlier version of this paragraph mistakenly said that the company’s “First Byte” service was already on the market.] Clearance in hand, company executives can now move beyond its initial alarm analytics dashboard program it has with institutions such as Texas Children’s Hospital and Seattle Children’s Hospital. Now it plans to deploy what it calls its “First Byte” service, which provides 60 days of data analytics on the alarm software and a holistic review of each institution’s ICU alarm practices.
So far, the company has raised $630,000 in seed funding, including a $500,000 chunk from Texas Children’s Hospital, with which Medical Informatics has a joint development project. The company will also do a clinical trial for the Seattle hospital looking at data from CPAP devices, which help treat obstructive sleep apnea.
Raff says the company is now working toward regulatory approval of additional applications, such as what Raff calls “critical events of deterioration.” “We want to take the data they get and enable them to predict a heart attack or an apnea event one to two hours in advance of when it happens,” he says.
Medical Informatics is talking to half a dozen hospitals in order to work together to validate such capabilities as the heart attack monitor. Raff says company officials hope to have enough data to be able to submit for additional FDA clearances next year.