Hemovent GmbH announced today that it won CE Mark approval for its Mobybox Runner controller for heart and lung support. The Mobybox is a miniaturized heart and lung machine designed to improve safety, ease of use, mobility and performance for supporting heart and lunch health. It utilizes the company’s Bionique Flow technologies used for gentle […]
Staar Surgical wins supplemental lens approval for Evo, Evo+, Visian
Staar Surgical (NSDQ:STAA) announced today that it won CE Mark approval for use of its three ICL lenses as supplemental lenses in post-cataract intraocular lenses surgery patients (pseudophakics). Lake Forest, Calif.-based Staar Surgical’s Evo, Evo+ and Visian lenses all earned the European approval. The Evo/Evo+ and Visian devices are implantable collamer lenses designed to treat myopia […]
Medtronic wins CE Mark for next-gen InterStim products
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The medtech giant plans to make the products available on the market on Jan. 15 to expand access to sacral neuromodulation (SNM) therapy for European patients, according to a news release. InterStim Micro is a rechargeable […]
Medtronic wins CE Mark for Percept PC neurostimulator
Medtronic (NYSE:MDT) said today that it has secured a CE Mark for its Percept PC neurostimulator. The medical device giant is touting Percept PC as the only deep brain stimulation (DBS) system launched in the EU with BrainSense technology — which senses and records brain signals while delivering DBS therapy to people with neurological disorders such […]
Polyganics’ Liqoseal sealant patch wins CE mark approval
Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after it won CE Mark approval. The Groningen, The Netherlands–based company’s Liqoseal dural sealant patch is designed to reduce cerebrospinal fluid (CSF) leakage following elective cranial surgery. Liqoseal’s European approval follows the Encase I clinical trial, which revealed an absence […]
BioNess wins CE Mark for StimRouter neuromod system
BioNess announced today that it won CE Mark approval for its StimRouter neuromodulation system indicated for the treatment of fecal incontinence. The StimRouter system previously won approval for treating chronic pain and overactive bladder. The small implantable system targets the tibial nerve near the ankle. Patients undergoing the StimRouter implant procedure receive one incision as […]
Roche wins CE Mark for blood glucose reading smartphone app
Roche (SWX: RO, ROG) today announced that it has obtained a CE Mark for its Accu-Chek SugarView app, which allows a person to read a blood glucose test strip without a meter. The smartphone app, which will be first available on certain phone models via the Google Play Store, instead uses the phone’s camera to […]
CSA Medical wins CE Mark approval for RejuvenAir System
CSA Medical announced this week that it won CE Mark approval for its RejuvenAir system for treating chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB). The RejuvenAir system that is designed to apply spray-liquid nitrogen at -196◦C in a circumferential pattern to central airways through a minimally invasive bronchoscopic procedure, freezing damaged surface area […]
Hologic wins CE mark approval for implantable tag
Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term placement. Under yesterday’s extension approval, the LOCalizer can now be implanted more than 30 days prior to a breast-conserving surgery to improve flexibility and convenience for both patients and providers. The LOCalizer is a […]
Misonix lands CE Mark for Nexus ultrasonic platform
Misonix (NSDQ:MSON) said today that it has received the CE Mark for a new ultrasonic surgical platform. The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions. The Nexus platform is driven by a new […]
iCad’s AI-assisted mammography tech wins CE Mark
iCad (NSDQ:ICAD) has won the CE Mark for its advanced artificial intelligence technology and workflow solution, ProFound AI for 2D mammography. The Nashua, N.H.-based cancer detection and radiation therapy devices maker developed the technology to boost breast cancer detection by identifying soft-tissue densities and calcifications. ProFound AI for 2D mammography is the latest addition to […]
- 1
- 2
- 3
- …
- 18
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube