Medical accessory maker DexCom appear Tuesday that the aggregation has accustomed a de novo approval from the FDA to advertise its latest connected glucose monitoring arrangement — the G6 — that requires no fingerstick calibration.
The accessory austere for patients 2 years old and college and can be acclimated both as a stand-alone CGM as able-bodied as for affiliation with automatic insulin dosing systems.
The authoritative nod “comes several months advanced of management’s” guidance, wrote Danielle Antalffy, an disinterestedness analysis analyst with Leerink Partners, a healthcare advance bank, in a analysis agenda Tuesday afterwards the advertisement was made.
But conceivably added importantly, the actuality that it can be chip with automatic insulin commitment systems bodes able-bodied for DexCom’s role in the bogus pancreas market. Antalffy acicular out that the DexCom G6 can assignment with insulin pumps actuality developed by Tandem Diabetes and Insulet with whom the San Diego aggregation has partnerships.
This ‘puts DexCom addition footfall afterpiece appear establishing the alleyway for an bogus pancreas,” Antalffy wrote.
While all this is acceptable account for DexCom, the de novo approval is additionally acceptable account for diabetes patients who may be application CGM systems that still crave feel afraid for accurateness and able calibration. And that, in turn, may drive adoption of CGM into the broader blazon 2 diabetes population.
“We abide to accept the CGM bazaar is accretion badly as new articles appear to market, active assimilation advisedly college from accepted high-teens levels in Blazon 1s and mid-single-digits in insulin-dependent Blazon 2 patients,” Antalffy wrote.
Here are some of the appearance of the device, per the account release:
Like added DexCom CGMs, the G6 can automatically accelerate glucose readings to a DexCom reciever or a accordant acute accessory every bristles minutes. The accessory works with adaptable apps such that abstracts can be aggregate by up to bristles people. Patients can additionally personalize active schedules so that he or she is acquainted of dangerousy low glucose levels in the blood.
DexCom is not the alone aggregation gluttonous to aggrandize its brand into the broader Blazon 2 diabetes market. A competitor, Medtronic, appear beforehand this ages that FDA accustomed it latest CGM arrangement – the Guardian Connect – which uses bogus intelligence technology to advice blazon 1 and blazon 2 diabetes patients exhausted aerial and low-glucose accompanying events. The Guardian Connect, which is already accustomed for blazon 1 diabetes patients, works with the Guardian Sensor 3 which is the latest sensor from Medtronic and admiral its amalgam closed-loop insulin pump, the 670G.
Meanwhile, the agreement mural for CGM has bigger abundantly and has acceptable benefited DexCom. CMS appear its accommodation to awning the CGMs for Medicare patients in January 2017 and in March of aftermost year said that patients who accept either Blazon 1 or Blazon 2 diabetes and who charge assiduously administer their insulin will be able to access agreement for the devices.
Correction: An beforehand adaptation of the adventure afield characterized the Guardian Connect CGM system. It is powered by the Guardian Sensor 3 which is the latest sensor from Medtronic.
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