Senseonics wins FDA approval for next-generation Eversense 180-day CGM, provides 2022 outlook

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) announced today that the FDA granted approval to its next-generation continuous glucose monitor system.

Germantown, Maryland-based Senseonics designed the Eversense E3, which includes proprietary sacrificial boronic acid (SBA) technology, to extend longevity to six months (180 days), having previously offered the system with a 90-day wear time.

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With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.

At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.

“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).

She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.

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Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’

Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) announced that it anticipates a decision from the FDA regarding the approval of its new CGM system within weeks.

The company is seeking a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy, with the next-generation Eversense matching performance levels compared to the current 90-day sensor available in the U.S., but with reduced calibration, down to one per day, with the duration extended to 180 days.

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Senseonics wins CE mark for remote glucose monitoring app for Android users

Senseonics’ Eversense continuous glucose monitor won FDA CLEARANCE/APPROVAL earlier this year. (Image from Senseonics)

Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval.

Germantown, Maryland-based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android available in the first quarter of 2022 on the Google Play Store.

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7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes.

This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes.

This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

Next>>
Read more
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7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those who live every day with diabetes.

This year, that aim remains the same, and medical technology companies all over the world continue to look for ways to help manage the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists who helped to discover insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for helping to manage and treat diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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Senseonics posts Q3 earnings beat, hopes for new FDA approval soon

Senseonics’ Eversense continuous glucose monitor won FDA CLEARANCE/APPROVAL earlier this year. (Image from Senseonics)

Senseonics (NYSE:SENS) shares ticked up slightly on third-quarter results that beat the consensus earnings forecast.

The Germantown, Maryland-based company posted profits of $42.9 million, or 8¢ per share, on sales of $3.5 million for the three months ended Sept. 30, 2021, for a massive bottom-line swing out of the red on sales growth of nearly $3 million.

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MedTech 100 roundup: Hot streak comes to slight halt

After several weeks of high-level performance, the medtech industry saw its first dip in a while over the last seven days.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 13) at 117.92 points, marking a -1.2% dip from the 119.41-point tally a week prior (Aug. 6).

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 27.7% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling an 89.8% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as the S&P 500 Index and Dow Jones Industrial Average fared almost identically, ticking up by 0.7% a…

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Senseonics slides on big earnings miss in Q2

Senseonics (NYSE:SENS) shares took a hit today on second-quarter results that missed the consensus earnings forecast.

The Germantown, Md.-based company posted losses of $180.3 million on sales of $3.3 million for the three months ended June 30, 2021, seeing its bottom line plummet from losses of just $7.5 million this time last year despite bringing in revenues more than 11 times of the tally registered in the second quarter of 2020.

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Senseonics touts new next-gen Eversense CGM data

Senseonics (NYSE:SENS) today presented further data evaluating its next-generation Eversense continuous glucose monitoring system.

Germantown, Md.-based Senseonics presented data from the Promise study at the American Diabetes Association Virtual 81st Annual Scientific Sessions. The data adds to positive results already presented by the company at the beginning of this month that demonstrated high levels of accuracy.

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Senseonics rises in pre-market trading on Street-beating Q1

Senseonics (NYSE:SENS) shares ticked up before hours today on first-quarter results that beat the consensus forecast.

The Germantown, Md.-based diabetes management technology developer posted losses of -$249.5 million, or -68¢ per share, on sales of $2.8 million for the three months ended March 31, 2021, registering a massive bottom-line slide from losses of -$42.6 million this time one year ago despite increasing sales from just $36,000 year-over-year.

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