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Diagnostics & Healthcare News

Flowonix Receives FDA Approval to Market Prometra II Pump for use with Intrathecal Baclofen

Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen. Flowonix introduced the Prometra II 40mL pump to the US market in November 2019, providing...

February 20, 2020

Imaging Visualization & Navigation

Compumedics Announces Milestone US FDA Approval for the Orion Lifespan MEG 

Compumedics Limited is pleased to announce that on February 14, 2020, it received 510(K) clearance from the US Food and Drug Administration (FDA) for its Orion LifeSpan™ Magnetoencephalography (MEG) single Dewar system. This news follows the successful installation and first phase...

February 19, 2020

Biologics, Wound Care, Infection Prevention

RedDress Announces Launch of ActiGraft, FDA-Cleared for the Treatment of Chronic and Acute Wound Types

RedDress, a privately held, Israel and U.S. based company, today announced the U.S. launch of ActiGraft, the first wound treatment that transforms – in real time – a patient’s blood into an autologous whole blood clot tissue. Once applied, ActiGraft serves as...

February 19, 2020

Cardiovascular / Cardiology

Cerus Endovascular Receives CE Mark Approval for its Contour Neurovascular System, Designed to Treat Intracranial Aneurysms

Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its lead product, the Contour Neurovascular System™, for the treatment of intracranial aneurysms. The Contour Neurovascular System™ is a unique,...

February 18, 2020

Orthopedics and Spine

CrossRoads Extremity Systems, LLC Announces Launch of the HiMax Plus Widebody Fixation System for Foot Fusions

CrossRoads® Extremity Systems, the global leader in Staple Compression Plates(SCP) and nitinol technology for the lower extremities, announced it has received FDA clearance and launched the HiMax® Plus Widebody Fixation System. HiMax® Plus is the only foot bone fusion system on the market to provide...

February 18, 2020

Diagnostics & Healthcare News

Baxter and COSMED Announce U.S. FDA 510(k) Clearance of Q-NRG+ Indirect Calorimetry Device 

Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology. IC is considered the “gold standard”1  to accurately measure...

February 17, 2020

Diagnostics & Healthcare News

Carelight Introduces Line Of FDA-Cleared Light Therapy Devices

CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to reduce pain...

February 17, 2020

Orthopedics and Spine

MEDICREA Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services...

February 13, 2020

Imaging Visualization & Navigation

World’s First Bedside MRI System Receives FDA 510(k) Clearance 

Hyperfine Research, Inc. announced today that it has received US Food & Drug Administration 510(k) clearance for the world’s first bedside Magnetic Resonance Imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system is 20X lower...

February 12, 2020