Senseonics receives CE approval to continuous glucose monitoring (CGM) system

Senseonics Holdings, Inc announced it has received CE Mark approval for the Eversense Continuous Glucose Monitoring (CGM) System.



“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” said Dr. Tim Goodnow, CEO and President of Senseonics. “The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes.”

The Eversense System includes an implanted glucose sensor that lasts up to 90 days, a wearable and removable smart transmitter to calculate glucose levels, and a mobile app for display of real-time glucose readings. The Eversense System is now the world’s first long-term wear sensor, which eliminates the weekly sensor insertion required by currently marketed CGM systems. The previously presented multi-center European PRECISE pivotal trial showed strong accuracy and safety results throughout the 90 day use of the Eversense CGM System.

Product details can be found from Senseonics website by clicking this link.

Vertebral Motion Analysis System Gets CE Mark

Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”. CE mark approval is required for the commercialization of the VMA in European markets. Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialize in the United States. With this additional approval, OKI can begin selling the VMA technology in European Countries.

VMA, or Vertebral Motion Analysis, is a diagnostic test for the assessment of spinal motion and radiographic instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the US, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown to be more accurate, repeatable, and result in a lower dose of radiation.

OKI intends to begin commercialization efforts later this year in the United Kingdom, then expand from there. To support commercial efforts, OKI will be working closely with local distribution partners in each country.

A press release can be found from OKI website by following this link.

Planmed digital breast tomosynthesis system receives CE mark

The Planmed Clarity 3D digital breast tomosynthesis system and the Planmed Clarity™ 2D full field digital mammography system have received the CE mark and are now available for sale in the EU and other countries where the CE mark applies. The systems have also won the prestigious Red Dot Design Award.

Digital breast tomosynthesis produces a 3D volume of the breast and resolves the challenge of overlapping tissue structures. This results in enhanced diagnostics, especially for patients with denser breast tissue. Planmed’s patented new tomosynthesis method significantly improves image accuracy and allows even the smallest details to be captured with great precision.

In addition to the Planmed Clarity 3D digital breast tomosynthesis system, the new product family also includes the Planmed Clarity 2D digital mammography system, which can be easily upgraded to digital breast tomosynthesis at any time. Both systems allow imaging with a low effective patient dose and feature a durable digital detector for mobile screenings, as well as the new Planmed Clarity Flow touch control with dual touchscreens.

More details can be found from Planmed website by clicking this link.

Boston Scientific Received CE Mark For MRI Labeling Of S-ICD Systems

Boston Scientific has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.

In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

"These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today," said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. "Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels."

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

For more information on the EMBLEM S-ICD Systems please visit www.sicdsystem.com.

St. Jude Launches New EnSite Precision Cardiac Mapping System in 9 European Countries

St. Jude announced expansion of its EnSite Precision™ cardiac mapping system limited market release in Europe and use of the new platform in more than 600 cases in nine countries since receiving CE Mark in January 2016. The mapping system is a next-generation platform designed to provide automation, flexibility and precision for tailored treatment in patients with cardiac arrhythmias. The launch constitutes introduction of an entirely new suite of technologies including innovations in hardware, catheters, surface electrodes (patches) and software features designed for improved ease of use. The system is currently available and expanding in select European countries as part of its initial launch and the company is currently pursuing U.S. Food and Drug Administration (FDA) clearance of the EnSite Precision cardiac mapping system.

The EnSite Precision cardiac mapping system is used in ablation procedures to visualize and navigate catheters in the heart. The system provides highly detailed anatomical models and maps to enable diagnosis of a wide range of arrhythmias, guide therapy and provide expanded procedural options to tailor care for patients. During this initial launch, the EnSite Precision cardiac mapping system was used in a variety of procedures, from simple to complex, including atypical flutter, paroxysmal and persistent atrial fibrillation (AF), and ventricular tachycardia (VT), with excellent system performance through challenging procedure dynamics.

The EnSite Precision cardiac mapping system uses intelligent automation tools to enable faster, more accurate high-density maps with greater consistency across cases. The system is flexible and enhances efficiency by allowing physicians to map heart chambers with any electrophysiology catheter and customize procedures to address the circumstances of each case. The EnSite Precision cardiac mapping system allows catheter navigation to occur with less fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure.

New release from St. Jude can be found from their website by clicking here.