Shares in Senseonics (NYSE:SENS) have fallen slightly today after the continuous glucose monitoring-focused medtech company posted first quarter earnings that missed on earnings per share expectations but beat sales consensus on Wall Street. The Germantown, Md.-based company posted losses of $22.3 million, or 16¢ per share, on sales of $2.9 million for the three months […]
FDA committee backs Senseonics’ implantable continuous glucose monitor
An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week. The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective. Get the full […]
Senseonics tops Q4 EPS estimates, misses sales expectations
Shares in Senseonics (NYSE:SENS) closed down -3% yesterday after the medical device maker met earnings expectations on Wall Street with its fourth quarter and full-year financial results, but narrowly missed sales estimates. The Germantown, Md.-based company posted a net loss of -$16.3 million, or -12¢ per share, on sales of $2.9 million for the 3 months ended […]
FDA panel to review Senseonics’ implantable CGM this month
A panel for the FDA is slated to review Senseonics‘ (NYSE:SENS) premarket approval application for its Eversense implantable continuous glucose monitoring system on March 29. The company’s device sends glucose data every five minutes to a transmitter, which then communicates that information to a mobile app, displaying the values in the real-time. The Eversense system […]
Senseonics’ implantable glucose monitor succeeds in 90-day trial
A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics. The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data every […]
Senseonics prices $50m notes offering, touts Q4 and full-year prelims
Senseonics (NYSE:SENS) announced today an underwritten offering of $50 million in 5.25% convertible senior notes due 2023, alongside a 30-day option for underwriters to buy up to an additional $7.5 million in notes to cover over-allotments. The notes, which mature on Feb. 1, 2023, will be convertible into shares of Senseonics’ common stock at approximately $3.40 […]
Senseonics tops sales estimates with Q3 results
Shares in Senseonics (NYSE:SENS) fell today even though the medical technology company beat expectations on Wall Street with its third quarter results. The Germantown, Md.-based company posted a loss of -$17.4 million on sales of $2.1 million for the 3 months ended Sept. 30. Get the full story at our sister site, Drug Delivery Business News.
Senseonics wins CE Mark for Eversense XL glucose monitor
Senseonics (NYSE:SENS) said yesterday that it won CE Mark approval in the European Union for its Eversense XL continuous glucose monitor. The Eversense XL includes a glucose sensor designed to be implanted for 180 days and a removable smart transmitter that links with a mobile app for real-time glucose monitoring. Germantown, Md.-based Senseonics touts the sensor […]
Senseonics prices $25m offering
Senseonics (NYSE:SENS) today priced an upcoming offering, looking to raise approximately $25 million to support its Eversense long-term implantable continuous glucose monitoring system. The Germantown, Md.-based company said it will look to float 11.6 million shares in the offering at a price of $2.15 per share. The offering will also include a 30-day underwriter’s option to […]
Senseonics expects FDA panel to consider Eversense CGM clearance
Senseonics (NYSE:SENS) said it expects the FDA will convene a special panel as it considers the company’s implantable Eversense continuous glucose monitors. The clarity came during the company’s 2nd quarter earnings call last week, with CEO Tim Goodnow saying the company expected the federal watchdog to look to an advisory panel, similar to its actions with Dexcom‘s (NSDQ:DXCM) […]
Senseonics inks artificial pancreas deal with Roche, TypeZero Technologies
Senseonics (NYSE:SENS) said today that it inked a collaboration with TypeZero Technologies and Roche (OTC:RHHBY) Diabetes Care to develop an automated insulin delivery system. The deal is part of an NIH-funded effort to test artificial pancreas systems. The trial is slated to integrate Senseonic’s Eversense glucose monitor, TypeZero’s inControl AP algorithms and Roche’s Accu-Chek Insight insulin pump. The software automatically […]
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