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Imaging Visualization & Navigation

Body 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...

October 6, 2022

Biologics, Wound Care, Infection Prevention

Pulse 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...

September 26, 2022

Imaging Visualization & Navigation

FDA 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...

September 22, 2022

Cardiovascular / Cardiology

OpSens 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...

September 20, 2022

Diagnostics & Healthcare News

Tasso+™ 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...

September 15, 2022

Cardiovascular / Cardiology

Potrero 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...

September 13, 2022

Surgery and Surgical Robotics

Aerin 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...

September 12, 2022

Surgery and Surgical Robotics

Serpex Medical Announces Second FDA 510(k) Clearance of Its Steerable Endobronchial Instrument Platform – The Compass Steerable Needle

Serpex Medical announced U.S. FDA 510(k) clearance of its Compass Steerable Needles – steerable biopsy needles that enable precise access to lung nodules in the intrapulmonary region. Serpex Medical seeks to leverage the power of steerable instruments to enable greater...

September 8, 2022

Surgery and Surgical Robotics

Magnus Medical Receives FDA Clearance for the SAINT Neuromodulation System

Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the SAINTTM Neuromodulation System for the treatment of major...

September 6, 2022