Medtronic

By Babyforyou.net.ua April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.  Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
By Jonah Comstock March 12, 2018
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016. "Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM...
By Dave Muoio February 26, 2018
The FDA has expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm. The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system. Along with the added convenience of the new sensor site, the company...
By Dave Muoio December 8, 2017
Heads of the FDA’s Center for Devices and Radiological Health (CDRH) recently penned a blog post describing their previous and ongoing efforts with closed-loop artificial pancreas manufacturers to ensure proper testing and validation of the devices.  In it, Courtney Lias, director of the Division of Chemistry and Toxicology Devices at CDRH, and Stayce Beck, chief of the Diabetes Diagnostics...
By Bill Siwicki October 18, 2017
Remote patient monitoring company Medtronic Care Management Services  is partnering with telemedicine technology and services vendor American Well to enable a complete telehealth system focused on the unique needs of the complex, chronic, co-morbid patient population. The businesses will work together to enable patient access to American Well’s telemedicine services on Medtronic Care Management...
By Jonah Comstock September 18, 2017
Medtronic has received FDA clearance for a new implantable pain management device that can be programmed wirelessly via a Samsung tablet. The Intellis system is designed to treat chronic pain by delivering neurostimulation at the spinal cord. Using a Samsung Galaxy Tab S2, the patient's caregiver can adjust the neurostimulation according to a workflow designed by Medtronic called Evolve. "Drawing...
By Jonah Comstock June 27, 2017
Diabetes data management company Glooko has raised $35 million in new funding. The company already had strategic investments from Samsung and Medtronic; in this new round the Mayo Clinic and insulin pump maker Insulet join those ranks. Toronto-based Georgian Partners led the round, with participation from existing investors Canaan Partners and Social Capital, in addition to the aforementioned...
By Jonah Comstock June 15, 2017
Late last week we did a pre-conference roundup of news from the 77th Scientific Sessions of the American Diabetes Association. Now that the show has concluded, here’s a few more notable stories from the show: Care4Life texting lowers A1C, but not as consistently as personal intervention One study presented at the conference looked at 166 Medicaid patients with Type 2 diabetes and an average HbA1c...
By Babyforyou.net.ua June 9, 2017
Diabetes management is a focus area for a number of digital health companies, and increasingly large medical device companies like Medtronic and Dexcom are turning to smartphone apps and connected devices for their consumer offerings. So it’s no surprise that at the 77th Scientific Sessions of the American Diabetes Association, which start today, there is a significant health tech presence.  We...
By Heather Mack March 31, 2017
In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner....

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