medical device guru

Orthopedics and Spine

ChoiceSpine® Announces Standalone Indication for Blackhawk® Ti 3D Printed Cervical Spacer System

ChoiceSpine LLC, a privately held spinal device company held by Altus Capital Partners in Knoxville, TN, is pleased to announce today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Blackhawk® Ti 3D Printed...

September 21, 2023

Imaging Visualization & Navigation

SpectraWAVE Secures 510(k) Clearance to Add Saline Imaging and Expanded Artificial Intelligence Features to the HyperVue™ Imaging System

SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue™ Imaging System. The intravascular...

September 20, 2023

Surgery and Surgical Robotics

CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System

CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt...

September 18, 2023

Diagnostics & Healthcare News

Beacon Biosignals Receives FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S

Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the...

September 14, 2023

Cardiovascular / Cardiology

Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Inspira™ Technologies OXY BHN Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device,...

September 13, 2023

Orthopedics and Spine

Orthofix Announces Leadership Changes

Orthofix Medical Inc. (NASDAQ: OFIX), a leading global spine and orthopedics company, today announced that Catherine Burzik, Chair of the Orthofix Board of Directors, has been appointed Interim Chief Executive Officer; Geoffrey Gillespie, Orthofix Vice President, Corporate Controller, has been...

September 12, 2023

Cardiovascular / Cardiology

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow...

September 12, 2023

Imaging Visualization & Navigation

Zeta Surgical’s Mixed Reality Navigation System Receives FDA Clearance

Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. The Zeta Cranial Navigation System is a mixed-reality navigation...

September 11, 2023

Cardiovascular / Cardiology

Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System

Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its...

September 8, 2023