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Medtronic Receives European Nod for Glucose Monitoring System

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Medtronic plc MDT announced that it received CE Mark approval for its advanced continuous glucose monitoring (CGM) system — the Envision Pro CGM — in Europe. Following the regulatory nod, the device will be commercially available in Europe and the Middle East later this year, subject to fulfillment of local regulatory requirements.

The advancement in the technology will enable medical professionals and patients with either type 1 or type 2 diabetes to monitor accurate glucose levels and trends over time to opt for more informed therapy plans.

Medtronic, the first company to have a physician-approved CGM system, believes that the launch of Envision Pro is a turning point as the system is its first disposable and zero calibration CGM.

The company expects to improve its presence in the European market through this recognition.

For investors’ note, CGM is used to measure glucose levels every five minutes through a tiny sensor inserted below the skin, typically in the abdomen or upper arm.

 


 

Envision Pro CGM

Envision Pro CGM records glucose data through the Envision recorder and produces up to five diagnostic reports, which can be reviewed by physicians. With these, healthcare providers can simplify therapy adjustments and suggest lifestyle change advises to patients to reduce excursions and associated risks of complications.

How is it an Improved Version?

Per the experienced medical fraternity, the earlier versions of CGM, using fingersticks and A1C, only reflected the variations of sugar levels throughout the day. However, with the technological advancement made with Envision Pro CGM, doctors can see a report about the percent of time patients are in the ideal target glucose range and when they are beyond the limits to make more informed treatment decisions.

Another advantage is that the sensor and recorder are fully disposable and there is no need to return them to physicians. Additionally, the recorder communicates with the patient’s smartphone wirelessly, which healthcare provider can obtain effortlessly, thus allowing remote monitoring of reports without in-office visits.

Given the huge potential for offering treatments to diabetic patients, the approval and subsequent launching decision have come at just the right time.

Industry Prospects

Per a report by Energias Market Research, the global CGM devices market is projected to grow significantly from $529 million in 2018 to $1,263 million in 2025, witnessing a CAGR of 12.4%. The major factor driving the market is the increasing prevalence of diabetes across the globe and the growing awareness among people. Also, increasing adoption of CGM devices is aiding market growth.

Given the current market prospects of diabetes management, the recognition has come at just the right time.

Recent Developments

Earlier this month, Medtronic announced the impressive findings on the real-world clinical outcomes on European patients for the MiniMed 670G system. The recorded data shows that on average, Time in Range of 73% surpassed the recommended Time in Range consensus guidelines of 70%.

During the same time, Medtronic also secured reimbursement for the MiniMed 670G insulin pump system with the German Federal Association of the Statutory Health Insurances (“GKV-SV”).

The company reached another milestone in September when it entered a partnership with Novo Nordisk A/S to develop solutions to assimilate insulin dosing data from future Novo Nordisk smart insulin pens into CGM devices from Medtronic, such as the Guardian Connect system.

Share Price Performance

The company has gained 14% in the past year compared with the industry’s growth of 0.1% and the S&P 500 index’s rally of 2.3% during the same period.

Zacks Rank & Other Key Picks

Currently, Medtronic carries a Zacks Rank #2 (Buy). A few other top-ranked stocks from the broader medical space are Capricor Therapeutics, Inc. CAPR, GW Pharmaceuticals PLC GWPH and Neurotrope, Inc. NTRP.

Capricor, with a Zacks Rank #2, has a projected third quarter 2019 earnings growth rate of 28.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.8%. It currently sports a Zacks Rank #1.

Neurotrope, with a Zacks Rank #2, has a projected third-quarter earnings growth rate of 27.7%.

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