|Proteus' ingestible sensor--courtesy of Proteus Digital Health|
Proteus Digital Health gained FDA de novo clearance for a new ingestible sensor designed to be combined with a drug, capping a four-year process of working with regulators to find the best approval path for the novel product.
As Proteus points out, its Ingestion Event Marker gained approval under a new patient care and medical device category, capping a regulatory push that began in 2008. The FDA's de novo process is saved for devices that are low risk but don't have a precedent on the market. Proteus has been armed with a CE mark since August 2010 for its broader technology platform, which gained FDA approval this month. As early as 2010, the company--when it was still called Proteus Biomedical--raised $25 million in a Series E funding round.
As designed, the ingestible sensor can be blended into an inert pill or other pharmaceutical that a patient swallows, after which a clinician gathers data it collects in order to form a patient treatment plan. In other words, patients will be able ingest digital medicine that treats an ailment but also gathers data that can be used for future care strategizing.
The Redwood City, CA company formerly known as Proteus Biomedical may not be known well, yet. But perhaps you'll recognize some of its investors: Medtronic ($MDT), Kaiser Permanente, Novartis ($NVS), and Otsuka, among others. In fact, Swiss Drug giant Novartis invested $24 million a few years back in order to test Proteus' technology on a drug already approved to prevent post-transplant organ rejection.
Stomach fluid activates the device, which transmits its identity and the time of ingestion by way of a patch worn on the skin. That patch is an important part of the company's "digital health feedback system" and collects heart rate, body position and other information, relaying the details by way of a mobile phone app. With a patient's OK, clinicians access that data and use it to help the patient make better health and care choices in addressing a disease or illness, longer-term.
- read the release
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