Sanitas Gets FDA Clearance to Market ‘Wellaho’ for Chronically Ill
Sanitas, a San Diego health IT startup, said yesterday the FDA has cleared its secure Web and mobile platform for supporting outpatients who are chronically ill.
The company submitted a premarket notification for Wellaho, its personalized outpatient management system, in late November. An FDA review agreed in January that Wellaho is a class II medical device that is substantially equivalent to technology available on the market, a designation that allows Sanitas to market its proprietary system in the United States.
When I met with Sanitas founder Naser Partovi in 2011, he described Wellaho as a HIPAA-compliant social media network for the chronically ill. Partovi described Wellaho during a phone call yesterday as more of an information-gathering platform that can be used in combination with a variety of patient monitoring devices.
“We’re integrating with various devices, one-by-one,” Partovi said. A patient using a Fitbit, for example, can upload daily activity data to their own Wellaho website. “We’re now integrating blood pressure and blood glucose monitors,” Partovi added.
The Wellaho system does not measure, interpret, or make data-based decisions on its own, Partovi said. Rather, it is a system for collecting physiological data—such as blood pressure, blood sugar levels, and patient vital signs—from outpatients being treated for cancer and other chronic diseases.
The company is targeting chronically ill patients with such diagnoses as diabetes, congestive heart failure, kidney disease, COPD, asthma, hypertension, breast cancer, sleep disordered breathing, and obesity. Sanitas has been working with UC San Diego Health Services in clinical studies focused on diabetes, congestive heart failure, and weight management.
Wellaho maintains patient data on a secure data storage server that can be accessed by the patient, the patient’s doctors, and certain other health care providers.
Partovi said Wellaho is designed to enable patients to provide daily personal updates about their own health status—to describe their relative fatigue, pain level, mood, and how well they’re eating. Patients also can use Wellaho to access medical information about their own health, monitor their condition, get relevant educational information, and to communicate with their doctors and healthcare team.
In an e-mail yesterday, Partovi wrote that the FDA clearance “means that Wellaho is the only clinically tested, FDA-approved chronic care management program covering over 80 percent of chronic conditions.”
In the statement from the company, Partovi says, “Patients with chronic conditions need a web of care, coming from the best that providers and technology can offer. Given the tsunami of new apps and technologies that hit the market each year, both patients and providers need the highest validation for the products and services they use.”
Sanitas currently has fewer than 10 employees, Partovi said. The company has no immediate plans to raise additional capital.