Jun 18,2018

FDA grants DreaMed's de novo request for device-friendly diabetes software

The FDA has granted Isreal-based DreaMed Diabetes a de novo request for its artificial intelligence-powered software for providers managing patients with Type 1 diabetes. Advisor Pro received a CE mark in February, and according to the company is being used by “leading clinical centers” in both the EU and the US.

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Jun 21,2018

Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).

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Jun 21,2018

Medtronic Receives FDA Approval of New Pediatric Indication for the MiniMed(TM) 670G Hybrid Closed Loop System in Children Ages 7-13

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the use of the MiniMed 670G system in patients with type 1 diabetes seven years of age and older.

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Jul 24,2018

Companion Medical Receives CE Mark

Diabetes care company Companion Medical has just landed a CE mark for its InPen, a smart insulin pen. The connected device has already been FDA-cleared but this latest announcement means that it will be able to go on the EU market.

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Jul 30,2018

Abbott Receives FDA Approval of a 14-Day Version of Its Freestyle Libre CGM

Abbott has received FDA approval of a 14-day version of its Freestyle Libre continuous glucose monitoring system. The disposable, fingerstick-free system is comprised of a tiny insertable sensor and a patch roughly the size of a quarter that is worn on the arm. It was first approved by the agency in September 2017, for up to 10 days.

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Sep 19,2018

The Actiste companion applications and The Benefit Loop are now CE certified.

The mobile applications and digital infrastructure of Brighter's award-winning service for insulin treated diabetics – Actiste® Diabetes Management as a Service – are now CE certified. The applications are offered exclusively to Actiste subscribers. Through The Benefit Loop, Actiste connects all relevant parties in the care chain; the patient receives support and guidance, relatives can monitor and the caregivers can adapt and improve.

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Nov 01,2018

With new FDA clearance, Abbott Freestyle Libre users can ditch handheld readers for an app

Just a short while after securing a CE Mark for its second generation device, Abbott has been granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10 to 14-day CGM. The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).

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Nov 06,2018

Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval for qualified health care providers to be trained and certified to provide patients with the highly accurate sensor that lasts up to three months.

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Nov 07,2018

Diabeloop obtains CE marking and launches new round of funding

Diabeloop announced today it has received the CE marking for the DBLG1™, its innovative technological solution to radically improve quality of life for T1D patients through better blood sugar management. This news represents an important step towards the commercial release of the product.

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Dec 10,2018

POPS! Diabetes Care scores 510(k) for connected glucose monitoring system

Last week, the FDA granted a 510(k) clearance to POPS! Diabetes Care for its latest product, the POPS! one blood glucose monitoring system.

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