Posts by cstephenson@legacymedsearch.com
Ambu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit
Ambu announces the 510(k) regulatory clearance of the Ambu® aScope™ Gastro and Ambu® aBox™ 2 in the United States. aScope Gastro is Ambu’s first sterile single-use gastroscope and includes new advanced imaging and design features in a combined solution with next-generation display and processor technology. With HD capabilities, the aBox 2 will set a new…
Read MoreA New Suturing Tool, Endomina System, from Endo Tools Therapeutics, Gains FDA Clearance
Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices for use by gastroenterologists, today announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of the endomina® system, designed for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract on adult population. The endomina system is comprised of a universal…
Read MoreMedtronic to Acquire Intersect ENT for $1.1B
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it has entered into a definitive agreement with Intersect ENT (NASDAQ: XENT), a global ear, nose, and throat (ENT) medical technology leader dedicated to transforming patient care, in which Medtronic will acquire all outstanding shares of Intersect ENT for $28.25 per share in an all-cash…
Read MoreTransMedics Receives FDA Clearance of OCS Lung Solution for Cold Preservation of Lungs
TransMedics Group, Inc. (“TransMedics”), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its OCS™ Lung Solution for use in transplants using cold storage techniques. The solution, which is also cleared as a component…
Read MoreCARMAT Announces the First Human Implant of its Total Artificial Heart in the United States
CARMAT, the designer and developer of the total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the first implantation of its bioprosthetic artificial heart, Aeson, in the United States within the framework of the Early Feasibility Study (EFS). The implant…
Read MoreDexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data
Dexcom’s Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users. Developers can integrate CGM data with their applications, diabetes management systems or devices through the new APIs, according to Thursday’s announcement. Diabetes management companies like Teladoc Health’s Livongo for Diabetes and…
Read MoreNeuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System
Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees. The FDA Breakthrough Device Program is intended to help patients…
Read MoreInterventional Systems Receives FDA Clearance for Miniature Surgical Robot for Needle-based Procedures
Interventional Systems announced Micromate, the world’s smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA. Micromate is a table-mounted medical robot for interventional procedures with a universal instrument guidance solution that allows physicians to continue using their preferred surgical instruments. Targeting is performed under live-imaging using…
Read MoreLatest iCad 3D Mammography AI Gains CE Mark
iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval. Compared to previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining an industry-leading high sensitivity…
Read MoreSpino Modulation Vertebral Body Tethering Device Wins FDA Breakthrough Device Designation
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely…
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