Posts by cstephenson@legacymedsearch.com
ulrich Medical USA™ Receives 510(k) Clearance for Flux-C™ 3D Printed Porous Titanium Cervical Interbody Prior to NASS
ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous titanium cervical interbody device. “Surgeons have many options for cervical interbodies. The Flux-C porous titanium device offers one of the…
Read MoreNevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain
Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that…
Read MoreXACT Robotics® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit
XACT Robotics®, developer of the world’s first and only comprehensive robotic system for interventional procedures, announced that its ACE Xtend™ Remote Control Unit received U.S. Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. The first-of-its-kind feature for CT-guided percutaneous procedures…
Read MoreBody Vision Medical Accelerates International Expansion with Business Asia Consultants, Inc., Partnership
Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced a new partnership with Business Asia Consultants (BAC), Inc. as part of its international expansion strategy. BAC will apply its extensive European, Asian and Latin American market development expertise to assist Body Vision Medical in realizing its market expansion goals. “We are excited about the…
Read MorePulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This…
Read MoreFDA Grants QT Imaging™ Clearance to Calculate Fibroglandular Volume of the Breast
The U.S. Food and Drug Administration (FDA) has granted QT Imaging, Inc. 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV). This ratio can contribute to an assessment of risk for breast cancer and changes in this ratio can be used to measure…
Read MoreOpSens Announces FDA Clearance for the SavvyWire™ for Use in Transcatheter Aortic Valve Replacement (TAVR) Procedures
OpSens Inc., a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (“FDA”) for the SavvyWire™ (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. “For OpSens, FDA clearance is a key milestone…
Read MoreTasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance
Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+™ lancet as a Class II medical device. The clearance allows the company to market and sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the country, expanding…
Read MorePotrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm
Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. Joe Urban, Potrero CEO stated “We celebrate the breakthrough designation, and we are excited about what this will…
Read MoreAerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis
Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. RhinAer is a non-invasive, temperature-controlled radiofrequency technology that durably treats the causes of rhinorrhea (runny nose), post-nasal drip…
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