News | May 09, 2007

Generic Medical Devices Receives Clearance for Universal Surgical Mesh

May 10, 2007 — Generic Medical Devices Inc. (GMD), a designer, developer, manufacturer and supplier of surgical products marketed at generic prices, announced that the FDA has cleared the GMD Universal Surgical Mesh for market. The availability of the Surgical Mesh will provide hospitals, ambulatory surgical centers and independent practitioners a low-cost opportunity to administer high-quality healthcare.

The GMD Universal Surgical Mesh is a Class II, non-active implantable medical device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the GMD Universal Surgical Mesh is based on the device being substantially equivalent - having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance - to pre-amendment devices and a product currently on the market.

The procedure for patients undergoing laparoscopic or open surgical hernia repair involves the implantation of a surgical mesh over the hernia defect to provide a platform for where tissue ingrowth can occur, healing the defect. The GMD Universal Surgical Mesh will be used for this purpose to repair hernia or other fascial defects that require the addition of a reinforcing or bridging material to achieve the desired surgical outcome.

GMD is the first company to implement the generic model, made successful by the pharmaceutical industry, within the medical device market. Leveraging expired patents on standard-of-care surgical devices that have undergone few, if any, changes since first being introduced to the market, GMD is bringing substantially equivalent alternatives to market at lower prices.

For more information visit

Related Content

DrChrono and 3D4Medical Partner to Bring 3-D Interactive Modeling to Physician Practices
News | Advanced Visualization | March 18, 2019
DrChrono Inc. and 3D4Medical have teamed up so practices across the United States can access 3-D interactive modeling...
IBM Watson Health Announces New AI Collaborations With Leading Medical Centers
News | Artificial Intelligence | February 14, 2019
IBM Watson Health announced plans to make a 10-year, $50 million investment in research collaborations with two...
Life Image and Bringing Artificial Intelligence to Clinical Trial Development
News | Artificial Intelligence | November 15, 2018
Life Image and announced a new strategic partnership that will facilitate the adoption and enhancement of...
News | PACS Accessories | October 01, 2018
M*Modal announced that several large U.S. health systems have adopted its cloud-based artificial intelligence (AI)...
Technology | Electronic Medical Records (EMR) | September 25, 2018
TransformativeMed, a provider of directly embedded, smart clinical workflow solutions for electronic health records (...
Study Points to Need for Performance Standards for EHR Usability and Safety
News | Electronic Medical Records (EMR) | July 18, 2018
A novel new study provides compelling evidence that the design, development and implementation of electronic health...
Drchrono EHR Partners With Ambra Health for Medical Imaging Access
News | Remote Viewing Systems | March 14, 2018
drchrono Inc. announced a new partnership with Ambra Health to give physicians and radiologists direct access to...
Cerner is extending its population health, clinical and administration portfolio with an integrated solution that combines Salesforce Health Cloud and Marketing Cloud with Cerner’s HealtheIntent, its big data platform.
News | Electronic Medical Records (EMR) | March 06, 2018
Cerner announced a new collaboration with Salesforce, a global leader in customer relationship management (CRM). Cerner...
electronic medical records
News | Electronic Medical Records (EMR) | June 15, 2017
During the first quarter of 2017, Black Book surveyed 140 chief information officers (CIOs), 159 chief financial...
News | PACS Accessories | April 25, 2017
April 25, 2017 — ImageMoverMD announced the availability of ImageMover Media, a universal, web-based solution to...