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Food and Drug Administration (FDA)

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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The Food and Drug Administration (FDA) has approved Boston Scientific’s ImageReady MRI labelling for the Vercise Gevia Deep Brain Stimulation (DBS) system to be used in a full-body environment. Read more

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Biomedical startup Adapttech has seen its technology for improving the fitting of lower limb prostheses receive approval from the Food and Drug Administration as a Class I medical device. Read more

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Dassault Systèmes has extended its collaboration with the U.S. Food and Drug Administration for another five years. Read more

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Web content editor Ian Bolland spoke to Morgan Palmer, chief technology officer and Kim Wakeman, solutions engineer at ETQ about the FDA’s decision to formally end the Alternative Summary Reporting (ASR) Program. Read more

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Medtronic is recalling 11 versions of its MiniMed insulin pumps amid fears of cybersecurity risks. Read more

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Johnson & Johnson Medical Devices Companies has announced that Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VistaSeal open and laparoscopic Dual Applicators (35 cm and 45 cm), for surgical bleeding. Read more

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Turbex is promoting its highly controllable, standard and bespoke cleaning equipment for washing and drying medical instruments, prosthetics and consumables after manufacture. Read more

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Boston Scientific has entered into a definitive agreement to acquire Vertiflex, a privately-held company which has developed and commercialised the Superion Indirect Decompression System. Read more

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The Food and Drug Administration has approved Boston Scientific’s Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. Read more

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CSA Medical has announced its RejuvenAir System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). Read more

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Drug delivery systems provider Aptar Pharma has announced that its Bidose nasal spray device was recently approved by the U.S. FDA for a breakthrough therapy in the field of depression. Read more

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