Search Results for 'pelvic organ prolapse'
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Surgical
J&J to Pay $117M to Settle Pelvic Mesh Lawsuits
Consumers were misled about safety, effectiveness, and potential risks of transvaginal mesh devices.New York State Attorney General 10.18.19
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Surgical
Researchers Seek to Develop Improved Pelvic Organ Prolapse Repair Device
Pitt researchers receive a $2.5M NIH award to create the new technology.University of Pittsburgh 05.07.19
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FDA Provides Further Update on 510(k) Modernization Efforts
The agency believes that additional changes are needed to fully modernize the 510(k) program.Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration 04.30.19
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Surgical
FDA Halts Sale of Pelvic Mesh in U.S.
FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.U.S. Food and Drug Administration 04.16.19
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CES 2019: InControl Medical Introduces Urinary, Fecal Incontinence Treatment
Attain device provides muscle stimulation, visual biofeedback, and a guided exercise program.Business Wire 01.10.19
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FDA Plans to Modernize 510(k) Program
Agency releases statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., director of the CDRH.U.S. Food and Drug Administration 11.26.18
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Surgical
FDA Updates Medical Device Safety Action Plan to Enhance Post-Market Safety
The agency aims to enhance medical device safety net and focus on several women's health devices.Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration 11.21.18
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ARMS Medical Announces 300 ‘No-Mesh’ Pelvic Floor Procedures by U.S. Surgeons
DermaPure allograft with dCELL technology provides an alternative to synthetic mesh in urogynecologic surgery.Business Wire 07.18.18
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ARMS Medical, Tissue Regenix BioSurgery Sign Distributor Agreement for DermaPure Allograft
Companies collaborate to educate surgeons and hospitals about the safety and performance advantages of DermaPure biologic.Business Wire 03.22.18
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Silicone Pessaries Offer Safe, Non-Surgical Alternative to Synthetic Mesh
Devices provide an effective way to manage pelvic organ prolapse.Mediplus 01.13.17
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FDA Strengthens Requirements for Transvaginal Surgical Mesh
PMA application now required for the reclassified Class III device.U.S. Food and Drug Administration 01.05.16
