The Longevity

New DexCom CGM System Receives FDA Clearance Ahead of Schedule

From the FDA’s landmark clearance of Medtronic’s continuous glucose monitoring (CGM) system to Fitbit’s announcement that their new smartwatch would display DexCom CGM data, it seems like blood glucose monitoring systems are constantly in the news. And the trend has continued this week, with DarioHealth’s announcement yesterday that it had received premarket notification to market its digital blood glucose monitoring system for iPhone 7, 8, and X followed by today’s news that Dexcom’s new CGM system, DexCom G6, has received FDA clearance ahead of schedule.

The regulatory nod “comes several months ahead of management’s” guidance, wrote Danielle Antalffy, an equity research analyst with Leerink Partners, a healthcare investment bank, in a research note Tuesday after the announcement was made.

The diabetes management world has long been ripe for disruption, and industry analysts believe that the news is a promising sign for DexCom, which may be angling to enter the artificial pancreas market.

But perhaps more importantly, the fact that it can be integrated with automated insulin delivery systems bodes well for DexCom’s role in the artificial pancreas market. Antalffy pointed out that the DexCom G6 can work with insulin pumps being developed by Tandem Diabetes and Insulet with whom the San Diego company has partnerships.

This ‘puts DexCom another step closer towards establishing the pathway for an artificial pancreas,” Antalffy wrote.

“We continue to believe the CGM market is expanding dramatically as new products come to market, driving penetration meaningfully higher from current high-teens levels in Type 1s and mid-single-digits in insulin-dependent Type 2 patients,” Antalffy wrote.

In addition, CGM companies like DexCom and Medtronic are likely to benefit from a friendly reimbursement climate, as healthcare payers continue to cotton on to the benefits of the technology.

Meanwhile, the reimbursement landscape for CGM has improved greatly and has likely benefited DexCom. CMS announced its decision to cover the CGMs for Medicare patients in January 2017 and in March of last year said that patients who have either Type 1 or Type 2 diabetes and who must intensively manage their insulin will be able to obtain reimbursement for the devices.

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