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Trinseo Received US FDA Approval for Considering Several Grades of Its Magnum ABS Resins
Aug 4, 2015Plastics, latex and rubber firm Trinseo has received US Food and Drug Association’s (FDA) approval for considering several grades of its Magnum ABS resins as food contact compliant. The approval of Food Contact Substance ...
Tags: ABS Resins, resins
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FDA's First Weight-Loss Device TP for Obese Adults to Dieting and Having Bariatric Surgery
Jan 19, 2015The EnterMedics Maestro Rechargeable System weight loss treatment device is effective although scientists are unclear why. The FDA has approved the first weight-loss device since 2007, giving obese adults an alternative to dieting and ...
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A New Technology Based on Fish Skin Can Be Used to Heal Human Skin Wounds.
Nov 22, 2013A new technology based on fish skin can be used to heal human skin wounds. This week, Kerecis Limited announced that it received FDA 510(k) clearance for a fish skin-based tissue regeneration technology. The technology is designed for the ...
Tags: Tissue Regeneration Technique, FDA
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IntelligentMdx Secured Clearanced From The US FDA for IMDX Vanr for Abbott M2000 Assay
Jul 30, 2013IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
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FDA Use Andrew Technologies For Autologous Fat Transfer Device
Apr 26, 2013Andrew Technologies has obtained 510 (k) clearance from the US Food and Drug Administration (FDA) for its Autologous Fat Transfer device. The liposuction device, which is based on Tissue Liquefaction Technology, reinjects the adipose ...
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Endoeye's Flex 3D System Is Obtained by Olympus
Apr 12, 2013Olympus has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its Articulating HD 3D laparoscopic surgical video system. The system, ENDOEYE FLEX 3D, when compared with conventional 2D surgical systems reduces ...
Tags: Olympus, FDA Nod, Flex 3D System
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FDA Has Approved Navidea Biopharmaceuticals' Lymphoseek Injection
Mar 15, 2013The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel product indicated for use in lymphatic mapping procedure. The lymphatic mapping procedure ...
Tags: FDA, Biopharmaceuticals, Navidea Biopharma
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On-X Life's Aortic Prosthetic Valve with Anatomic Sewing Ring Has Been Accepted by FDA
Mar 4, 2013On-X Life Technologies has gained US marketing rights to its new On-X aortic prosthetic valve with anatomic sewing ring, following the regulatory approval from the US Food and Drug Administration (FDA). The prosthetic valve, which is made ...
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The US FDA Has Approved Novartis Zortress as The First Drug to Prevent Organ Rejection
Feb 19, 2013The USFDA has approved Novartis Zortress as the first drug to prevent organ rejection in adult patients receiving liver transplantation in the US. The approval was based on positive data from liver transplant study that compared Zortress ...
Tags: medication, FDA, Zortress
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FDA Nod for Planmed Verity Extremity Scanner Goes to Planmed
Feb 18, 2013Planmed Oy has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Planmed Verity Extremity Scanner for providing fast 3D imaging of subtle extremity fractures that have been missed when using 2D radiographs at ...
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FDA Nod for Multi-Therapy Infusion System Belongs to Smiths Medical
Feb 13, 2013US-based Smiths Medical has gained US marketing rights for its CADD-Solis variable infusion profile (VIP) ambulatory infusion system, following the US Food and Drug Administration (FDA) approval. The multi-therapy infusion system, which ...
Tags: FDA, therapy infusion system, Medical
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Biophotas Has Gained The US Marketing Rights for Its Light Therapy Device
Jan 7, 2013BioPhotas has gained the US marketing rights for its light therapy device,designed to treat acne,muscle and joint pain,muscle and joint stiffness,muscle spasm,arthritis and compromised local blood circulation,following the US Food and Drug ...
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Abbott Has Obtained Regulatory Approval for Its Eluting Coronary Stent System
Jan 4, 2013Abbott has obtained regulatory approval for its XIENCE Xpedition Everolimus Eluting Coronary Stent system,designed for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary ...
Tags: Abbott, FDA, Drug Eluting System, XIENCE, symptomatic heart disease
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Angiotech Pharmaceuticals Has Obtained US Marketing Rights for Biopsy Device System
Dec 25, 2012Angiotech Pharmaceuticals has gained US marketing rights for its Bio-Seal Lung Biopsy Tract Plug system, following the approval from the US Food and Drug Administration (FDA). Featuring a proprietary hydrogel plug, the proprietary biopsy ...
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Aurobindo Pharma Has Won The Final FDA Approval
Dec 20, 2012Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg. Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets ...
Tags: Anti-HIV Drug, FDA Nod, Aurobindo, Medicine