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Food and Drug Administration (FDA)

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Cleveland Clinic

Patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea have been cleared by the Food and Drug Administration (FDA). Read more

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Reflow Medical’s retrievable stent technology, Temporary Spur Stent System, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). Read more

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AI solutions provider Aidoc has received FDA clearance for its package that can flag Large-Vessel Occlusion (LVO) in head CTA scans. Read more

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A surgeon from The Robotic Spine Institute of Silicon Valley has announced a procedure has taken place using a Molybdenum-Rhenium (MoRe) rod in a patient. Read more

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The Food and Drug Administration (FDA) has approved a surgical technique for Abbott’s HeartMate 3 heart pump aimed to allow more advanced heart failure patients to avoid open heart surgery. Read more

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Farhan Hussain

Wearables player Reliefband Technologies, has announced the unveiling of its new travel and sport therapeutic devices. Read more

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Medtech company Beta Bionics has received FDA Breakthrough Device designation for its automated bionic pancreas – the iLet Bionic Pancreas System. Read more

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The Food and Drug Administration (FDA) has cleared a cranial robotic platform that integrates with Medtronic technology to create an end-to-end procedural system. Read more

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The Food and Drug Administration (FDA) has cleared Boston Scientific’s EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Read more

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The Food and Drug Administration (FDA) has authorised marketing of a diagnostic test based on bacterial viability and novel technology to detect MRSA. Read more

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Heart device company BioVentrix has received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its Revivent TC Transcatheter Ventricular Enhancement System for heart failure. Read more

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Ultromics has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its image analysis system, EchoGo Core. Read more

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XACT Robotics’ first robotic system has been cleared by the Food and Drug Administration (FDA) for use during computed tomography (CT) guided percutaneous interventional procedures. Read more

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GI Scientific has had its ScopeSeal Duodenoscope Protective Device, an Endoscopic Shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures, cleared by the FDA. Read more

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Garwood Medical Devices has been granted “Breakthrough Devices” designation from the U.S. Food and Drug Administration (FDA) for its BioPrax device. Read more

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The Medical Device Innovation Consortium (MDIC) has been awarded $2.8 million in funding by the U.S. Food and Drug Administration (FDA) for the expansion of the Case for Quality and medical device cybersecurity programs. Read more

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OraSure Technologies has seen its OraQuick Ebola Rapid Antigen Test approved for use by the Food and Drug Administration. Read more

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Omnia Medical’s ‘Boxcar’ has been granted FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions. Read more

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Joint preservation developer Active Implants has been granted Breakthrough Device Designation from the Food and Drug Administration for its NUsurface Meniscus Implant. Read more

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3D Systems has received 510(k) clearance for its D2P (DICOM-to-PRINT) software allowing clinicians to 3D print diagnostic patient-specific anatomic models. Read more

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