Companion Medical said today it won FDA 510(k) approval for its wireless-enabled InPen insulin pen and mobile application.

The InPen is designed to connect to smartphones via bluetooth and send data back, including insulin dosage and timing, the company said. The app allows patients to track and calculate doses, and set alarms for future doses.

“FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care. The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally.  We are excited to be the 1st to introduce this entirely new class of insulin delivery,” CEO Sean Saint said in a press release.

San Diego-based Companion Medical said the InPen is cleared for use in the U.S. with Eli Lilly (NYSE:LLY) Humalog or Novo Nordisk Novolog rapid acting insulin.

The InPen application is currently cleared through Apple‘s (NSDQ:AAPL) iOS with plans for a Google (NSDQ:GOOG) Android version in late 2016, Companion Medical said.

“Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilize blood sugar levels and prevent long-term complications. Smart pens offer an improved dosing option for people living with diabetes, the majority of whom do not use insulin pumps.  The InPen adds a clinician-configured bolus calculator to the ability to give multiple doses of insulin each day safely and discreetly.  The insulin data can be shared with clinicians, allowing for optimized treatment planning,” Dr. Timothy Bailey said in a prepared statement.

In May, Companion Medical said it raised $3.2 million of a hoped for $3.5 million in a Series B round from 3 investors, including pharmaceutical company Eli Lilly.

Companion Medical said the funds are slated to help pursue FDA 510(k) clearance for its Bluetooth-enabled insulin pen and connected smartphone app.

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