Regulatory

VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination

October 18, 2018 IRVINE, Calif.--(BUSINESS WIRE)--Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art

By |2018-10-18T18:16:18+00:00October 18th, 2018|Regulatory|
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TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

October 11, 2018 RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received FDA 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments. The

By |2018-10-11T17:17:08+00:00October 11th, 2018|Regulatory, Robotics|
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Medacta International Adds Mpact 3D Metal Implants and Augments to Mpact System for Primary Hip Replacement and Revision Surgeries

October 11, 2018 CASTEL SAN PIETRO, Switzerland--(BUSINESS WIRE)--Medacta® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact® System for primary to complex hip revision

By |2018-10-11T16:43:36+00:00October 11th, 2018|Recon, Regulatory, Top Stories|
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K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA® Platform Using Patient-Specific Rods & Rails

LEESBURG, Va., Oct. 10, 2018 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced at the Scoliosis Research Society 53rd Annual Meeting & Course, in Bologna, Italy a U.S. Food and Drug Administration (FDA) 510(k) clearance that

By |2018-10-10T22:30:27+00:00October 10th, 2018|Regulatory|
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SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices

FREMONT, Calif., Oct. 10, 2018 /PRNewswire/ -- SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device. The LLIF procedure

By |2018-10-10T16:51:09+00:00October 10th, 2018|Regulatory, Spine, Top Stories|
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CVS Health Acquisition of Aetna Moving Forward on Agreement with U.S. Department of Justice

WOONSOCKET, R.I., Oct. 10, 2018 /PRNewswire/ -- CVS Health (NYSE: CVS) today announced that it has entered into an agreement with the U.S. Department of Justice (DOJ) that allows it to proceed with its proposed acquisition of Aetna (NYSE: AET). DOJ clearance is a key milestone toward finalizing the transaction, which is also subject to state regulatory approvals, many of

By |2018-10-10T16:27:33+00:00October 10th, 2018|Regulatory|
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Bioventus Receives ANVISA Approval to Market DUROLANE® in Brazil and Selects Pfizer as Exclusive Distribution Partner

October 02, 2018 HOOFDDORP, Netherlands--(BUSINESS WIRE)--Bioventus, a global leader in orthobiologic solutions, has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved DUROLANE for the symptomatic treatment of mild to moderate knee and hip OA. In addition, Bioventus has selected Pfizer as its exclusive

By |2018-10-02T15:23:13+00:00October 2nd, 2018|Regulatory|
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TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System

October 01, 2018 RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received CE Mark approval for its Senhance Ultrasonic Instrument System. Advanced energy devices, including ultrasonic devices, represent some of

By |2018-10-01T14:51:36+00:00October 1st, 2018|Regulatory|
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Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System

REDLANDS, Calif. and AUSTIN, Texas, Sept. 26, 2018 /PRNewswire/ -- Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest product to utilize Renovis' proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and

By |2018-09-28T22:26:34+00:00September 28th, 2018|Regulatory, Top Stories|
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Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System

KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ -- Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the

By |2018-09-27T22:22:18+00:00September 27th, 2018|Regulatory, Spine|
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Odysseus Medical Solutions 2018
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