Posts by cstephenson@legacymedsearch.com
Misonix Announces CE Mark Approval for Nexus Ultrasonic Platform
Misonix, Inc, a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that it has received Conformité Européene (CE) Mark approval for Nexus. The CE marking confirms that Nexus meets the requirements of the European Medical Devices Directive, which now allows Misonix to commercialize Nexus and its disposable products across the European…
Read MoreCorindus Vascular Robotics to be Acquired by Siemens Healthineers for $1.1B
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced that it has entered into a definitive merger agreement to be acquired by Siemens Healthineers AG. Under the terms of the merger agreement, Siemens Medical Solutions, a wholly-owned subsidiary of Siemens Healthineers AG, a German stock listed company, will acquire all issued and…
Read MoreNovel Imaging Method Limits Radiation Dosage from PET, SPECT Scans
A team of Japan-based researchers have created a medical camera capable of detecting and imaging radiotracers used in both PET and SPECT scans with limited radiation dosage. Detailed in Physics in Medicine & Biology, the Compton camera can detect gamma rays in both low and high energy ranges without the need of collimators. Its creators noted…
Read MoreEndotronix Announces FDA Approval to Begin Landmark PROACTIVE-HF Pivotal Trial for Cordella PA Pressure Sensor System
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor). The innovative trial…
Read MoreTransMedics Touts Long-Distance Organ Transport from Hawaii to North Carolina
TransMedics Group, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced the OCS Lung technology was used in two successful lung transplants using donor lungs from Hawaii that initially were declined for transplantation due to time and distance limitations of standard cold…
Read MoreAllergan Recalls Textured Breast Implants Linked to Rare Type of Cancer
The FDA said today that it asked Allergan to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma. The federal safety watchdog said that nearly 84% of the 573 cases of breast implant-associated anaplastic large cell lymphoma reported worldwide…
Read MoreImagion Biosystems Receives FDA Breakthrough Device Designation
Imagion Biosystems is working to differentiate itself in cancer detection with a system that aims to minimize the need for surgical or biopsy procedures to obtain tissue for pathological assessment. It says the technology as an alternative to MRI, PET, CT and X-ray for faster detection and treatment than conventional imaging methods, according to a presentation to…
Read MoreMedtronic to Distribute Viz.ai’s Stroke Imaging Software
Medtronic, a global leader in medical technology, and Viz.ai, the emerging leader in applied artificial intelligence (AI) in stroke care, have partnered to accelerate the adoption of Viz.ai’s new technology, which helps synchronize stroke care and decrease time to treatment, potentially improving outcomes for patients. Viz.ai’s technology uses artificial intelligence to identify suspected large vessel…
Read MoreCentinel Spine Announces IDE Approval of Two Different Prodisc C Devices
Centinel Spine said earlier this week that it won an investigational device exemption from the FDA for a clinical trial of its Prodisc cervical disc implants. New York City-based Centinel acquired the Prodisc assets from Johnson & Johnson subsidiary DePuy Synthes in December 2017 for an undisclosed amount. The FDA IDE covers a two-level study of the company…
Read MoreInsightec Receives FDA Approval and CE Mark for Exablate Neuro with GE SIGNA Premier MRI
GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced FDA approval and CE mark for Exablate Neuro™ compatible with the SIGNA™ Premier MRI system from GE Healthcare. The Exablate Neuro is a focused ultrasound platform for treating deep in the…
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