CE Mark Archives - Medical Design Sourcing

Medtronic wins CE mark for MiniMed 780G with Simplera Sync disposable, all-in-one CGM

The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its MiniMed 780G system with Simplera Sync.

Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM), eliminates the need for fingersticks and overtape. It features an improved user experience at half the size of previous Medtronic sensors with a simple, two-step insertion process.

MiniMed 780G, an automated insulin delivery system, offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

Get the full story at our sister site, Drug Delivery Business News.

Medtronic wins CE mark for rechargeable deep brain stimulation tech

The Percept RC device. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced that it received CE mark approval for its Percept RC neurostimulation device.

The medtech giant labeled the deep brain stimulation (DBS) device as the smallest and thinnest device on the market. Also rechargeable, the system features BrainSense sensing technology. Medtronic says its launch marks the first release of a rechargeable DBS system with this sensing technology in Europe.

BrainSense technology enables physicians to track patient brain signals and correlate them with patient-recorded events. These include symptoms or side effects associated with diseases such as Parkinson’s disease. Physicians can also correlate to medications, tailoring therapy to a patient’s evolving needs.

“This development represents a critical step in our journey to transform brain modulation through sensing-enabled DBS,” said Amaza …

Medtronic wins CE mark for next-gen Simplera CGM with InPen integration

The InPen and Simplera system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM).

The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Medtronic’s newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin pen for real-time, personalized dosing guidance to simplify diabetes management.

Medtronic plans to begin a phased launch for Simplera at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting. It takes place in Hamburg, Germany, from Oct. 2-6.

Commercializing a new CGM comes at a good time for Medtronic, which could see the benefits from the newly popular GLP-1 drug class. Analysts recently outlined the ways in which those drugs m…

Moon Surgical picks up CE mark for updated Maestro surgical robot

The Maestro surgical robot. [Image courtesy of Moon Surgical]Moon Surgical announced today that it received CE mark approval in Europe for the latest version of its Maestro surgical robot system.

The initial version of Maestro received CE mark approval earlier this year in April. This milestone marks the latest in a string of positive updates for Moon Surgical, which raised $55.4 million in May. The company also announced at that time that it appointed surgical robotics veteran Fred Moll to its board.

Paris-based Moon Surgical says the updated Maestro system features enhanced scalability and refined aesthetics. Other improvements over its previous iteration include an automated set-up with bedside guidance and tailored surgeon configurations.

Additionally, the new Maestro features cloud connectivity for a more integrated operating room and ecosystem experience. It provides surgeon-guided, hands-free scope control for optimized vision capabilities.

Mo…

Quantum Surgical wins CE mark to treat lung tumors with its surgical robot

The Epione surgical robot system. [Image from Quantum Surgical]Quantum Surgical recently announced that it received expanded CE mark approval for the use of its Epione surgical robotic platform.

The Montpellier, France-based company won expanded indications for Epione in the treatment of lung tumors.

Epione, the company’s flagship product, offers curative treatment for cancers. Quantum Surgical designed it to plan, target, deliver and confirm tumor ablation in a minimally invasive procedure. The percutaneous ablation system uses a robotic arm, a navigation system and a camera.

It enables physicians to treat inoperable, particularly difficult-to-reach tumors at an early stage in a simple and effective way. Epione’s uses include the treatment of abdominal tumors, including in the liver, kidney and pancreas.

Having received FDA 510(k) clearance in March 2022, Epione has treated more than 200 patients in France and the U.S. to date.

Qu…

Medtronic wins CE mark for Inceptiv spinal cord stimulation system

The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its Inceptiv spinal cord stimulator (SCS).

Inceptiv, a closed-loop, rechargeable SCS, treats chronic pain. Medtronic said it’s the company’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

According to a news release, certain movements during SCS therapy may result in uncomfortable stimulation. That, in turn, can lead to patients turning down their device’s stimulation output, negating their therapy.

Conversely, Inceptiv senses the body’s neural response to stimulation 50 times per second, every second, every day. When neural response increases — for …

Innovation Zed wins CE mark for insulin pen add-on device

The InsulCheck Dose device. [Image courtesy of Innovation Zed]Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose add-on device.

Dublin, Ireland-based Innovation Zed designed the InsulCheck Dose device as a single-unit add-on device for pen injectors. It automatically captures dose value dialed, injection event time stamps and temperature. The device also captures mounting and unmounting events.

Get the full story at our sister site, Drug Delivery Business News.

Medtronic wins CE mark for extravascular defibrillator system

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system.

The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it avoid certain risk with its lead placed outside the heart and veins.

Aurora remains investigational in the U.S. Medtronic plans to make it commercially available in select European countries in autumn 2023.

Patients who receive the Aurora EV-ICD system have defibrillation, anti-tachycardia pacing (ATP) and back-up pacing therapies available through a single implanted device. The device offers similar size, shape and longevity to traditional ICDs, Medtronic said. It also features proprietary procedure implant …

Varian wins U.S., European clearance for radiotherapy systems

The Halcyon radiotherapy system. [Image from the Varian website]Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems.

Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses include replanning and adaptation to patient and tumor changes.

HyperSight uses cone-beam computed tomography (CBCT) technology. This delivers larger images with better contrast. Varian said in a news release that this method is 10 times faster than conventional linear accelerator-based imaging systems. Traditional CBCT imaging may take up to 60 seconds and require patients to hold their breath. HyperSight acquires images in six seconds, potentially minimizing patient discomfort and anxiety while offering …

Getinge partners with Medtronic to make Radiant balloon-expandable covered stent

The Radiant balloon-expandable covered stent created by Medtronic and Getinge [Image from Medtronic]Getinge announced today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark.

Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft.

The medtech giant said that Radiant is the first and only covered stent indicated for such use. It comes from a long-term collaboration between Medtronic and Getinge. The platform leverages Getinge’s Advanta V12 balloon expandable covered stent design.

Get the full story at our sister site, Medical Tubing & Extrusion.

Insulet wins CE Mark for Omnipod 5 for children 2 and up

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system.

Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system

The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals 6 years of age and older. Last month, the FDA cleared Omnipod 5 for individuals aged 2 and older.

Get the full story at our sister site, Drug Delivery Business News.

Senseonics wins CE mark approval for 180-day Eversense E3 CGM

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) announced today that it received CE mark for the next-generation Eversense E3 CGM system.

Germantown, Maryland-based Senseonics offered its previous-generation continuous glucose monitor (CGM) with a 90-day wear time. Its next-generation Eversense E3 can be used for up to six months (180 days).

Get the full story at our sister site, Drug Delivery Business News.