Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen.

"FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and Tandem Diabetes Care, said in a statement. "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 first to introduce this entirely new class of insulin delivery."

The InPen is meant to be a more cost-effective tool for people with diabetes who "cannot or will not" use an insulin pump, according to Companion's website. The device and app can calculate and recommend optimal dosing, track history and timing of doses, monitor insulin temperature, display last dose and insulin-on-board, and report data to the user's health care provider. It's cleared to work with two brands of rapid-acting insulin: Novolog from Novo Nordisk and Humalog, from Eli Lilly.

"Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilize blood sugar levels and prevent long-term complications," Dr. Timothy Bailey, an endocronologist and clinical associate professor of medicine at the University of California at San Diego, said in a statement. "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."

Lilly's investment in Companion Medical last year (undisclosed at the time but since reported to be $3 million) was notable because, relative to other pharma companies, the Indianapolis-based giant hasn't been much involved with digital health. Lilly's investment came on the heels of its announcement of a new innovation center in Kendall Square in Cambridge, Massachusetts. The focus of that center is also on drug delivery and device innovation with a particular focus on diabetes.