Search Results for 'surgical mesh'
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Surgical
Boston Scientific to Pay $189M to Settle Charges Over Surgical Mesh
The company misled consumers about its surgical mesh devices' safety and effectiveness.Sam Brusco, Associate Editor 03.25.21
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SIA Enrolls First Patient in Study of its Surgical Mesh for Breast Reconstruction
The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding.Michael Barbella, Managing Editor 03.17.21
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Johnson & Johnson Fined $344M in Pelvic Mesh Case
A J&J spokeswoman said the company will appeal, claiming surgical mesh risks were responsibly communicated.Sam Brusco, Associate Editor 01.31.20
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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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Attorney General Morrisey Sues Johnson & Johnson
Alleges that the company engaged in unlawful and deceptive marketing practices.West Virginia Attorney General's Office 09.19.19
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Surgical
FDA Offers Update on Efforts to Ensure Breast Implant Safety
FDA hopes to ensure that women have the most complete information available to make important breast implant decisions.Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner; Jeff Shuren, M.D., J.D., CDRH Director 05.06.19
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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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Erasmus University MC Investigating New Surgical Matrix to Reduce Post-Operative Complications
Research shows surgical matrices can prevent incisional hernia after laparotomy.Novus Scientific AB 04.08.19
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Packaging & Sterilization
FDA Aims to Prevent Shortages Following Sterilization Shutdowns
The agency will work to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility and the planned shutdown of another.U.S. Food and Drug Administration 03.27.19
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Surgical
FDA Clears Via Surgical's FasTouch Absorbable Fixation System
The system is used for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.PR Newswire 03.18.19
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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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Surgical
FDA Clears Surgical Innovation Associates' Bioabsorbable Mesh for Reconstructive & Cosmetic Surgery
Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue.Business Wire 09.07.18
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Novus Scientific Relaunches TIGR Matrix Surgical Mesh in U.S. Market
Resorbable surgical mesh to support and reinforce soft tissue before absorbing completely.Business Wire 03.16.18
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Cohera Medical's Drain-Free Mastectomy Trial Reaches Full Enrollment
Eleven breast centers comparing mastectomy flap closure using TissuGlu without surgical drains vs. standard of care.Globe Newswire 11.02.17
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Cohera Medical Announces Exclusive Distribution Agreement for Cohera’s Sylys Surgical Sealant
Agreement provides for license, marketing rights to the sealant for current and future indications in Japan.Cohera Medical Inc. 09.18.17
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TissuGlu Surgical Adhesive Enables Drain-Free Recovery in Breast Reconstruction Patients
Effective donor-site flap closure with TissuGlu Surgical Adhesive is a viable alternative to post-surgical drains.Cohera Medical Inc. 06.08.17
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Cohera Medical Completes Enrollment in a Clinical Comparison of TissuGlu Surgical Adhesive
Study is designed to advance understanding of the economic value of drain-free abdominoplasty.Business Wire 05.02.17
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Surgical
Cohera Medical Hires New Sales VP
Latest hire has more than 20 years of experience launching, marketing, and selling aesthetic medical devices.Cohera Medical Inc. 03.01.17
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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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R&D & Design
Cohera Medical Enrolls First Patient in Clinical Trial of its Sylys Surgical Sealant
Surgical sealant designed to help reduce anastomotic leaks for patients undergoing colorectal surgery.Cohera Medical Inc. 01.04.17
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Contract Manufacturing | Software & IT | Testing
Status Quo
Medtech’s unexceptional year lacked the poignant moments and historic flavor of 2015.Michael Barbella, Managing Editor 11.08.16
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R&D & Design | Testing
Cohera Medical Appoints Board Member
Newest member is founder and CEO of Roka Bioscience.Cohera Medical Inc. 08.01.16
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R&D & Design
Cohera Medical Receives FDA Approval to Begin U.S. Clinical Trials of its Sylys Surgical Sealant
Sylys received Expedited Access Pathway status from the FDA in 2015.Cohera Medical Inc. 07.15.16
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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
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FDA Zeros in on Surgical Mesh Use in Women
Agency wants more safety data when used to treat incontinence.Chris Delporte 01.10.12
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FDA Orders Studies of Surgical Mesh
Agency wants more information on mesh used to treat urinary incontinence in women; companies could face financial penalties for non-compliance.01.05.12
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FDA Raises Red Flags AboutSurgical Mesh Use in Women Women who have vaginal surgery to fix a comm
...07.26.11
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FDA Issues Health Notice for Transvaginal Placement of Surgical Mesh
Nine manufacturers report erosion of device in patientsEditor 11.03.08
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FDA Issues Health Notice for Transvaginal Placement of Surgical Mesh
Nine manufacturers report erosion of device in patientsEditor 11.03.08
