medical device guru

Axoft Launches Brain Implant Technology to Treat Long-Term Neurological Disorders and is Granted FDA Breakthrough Device Designation

Axoft, a neurotechnology company, launched and announced FDA Breakthrough Device designation for its brain-machine interface (BMI) to better treat neurological disorders. The company secured $8 million in capital to fund pre-clinical studies with the FDA and to scale up prototypes...

October 18, 2022

Orthopedics and Spine

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...

October 14, 2022

Orthopedics and Spine

Nevro 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...

October 13, 2022

Surgery and Surgical Robotics

XACT 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...

October 11, 2022

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