Florida-based etectRx received FDA approval for its smart pill technology through the agency’s 510(k) clearance program, which accelerates the approval process for device-makers by allowing them to compare their product to another product that’s currently on the market.
For context, etectRx develops wireless microsensors that can be embedded into pills that will track and alert the patient’s physician through a smartphone app when taken — so long as the patient is wearing an etectRx lanyard-based chip reader around their neck at the time.
The company pointed regulators toward Proteus Health’s smart pills as an example of a similar product to earn the FDA’s nod of approval, but that comparison doesn’t exactly bode well for etectRx’s long-term success: Proteus suffered a major funding setback recently after $100 million was pulled back by investors, despite research illustrating
Proteus’ ability to improve medication adherence for some patients. So, while poor med adherence costs the US healthcare system over $300 billion each year, it’s not clear yet that pills decked out with expensive microsensors are the smartest way to address the issue.