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FHC's Custom Surgical Platform™ Wins Medical Design Excellence Award, cont. FHC's microTargeting™ Platform is an innovative surgical device and planning system that has the potential to transform functional neurosurgery from a marathon surgical event that routinely immobilizes an awake patient for up to 12 hours, into an out-patient scanning visit followed by a shorter surgery. "We believe that patient customized surgical fixtures are an idea whose time has come," says Ron Franklin, FHC's Stereotactic Technology Development Manager. "They improve the quality and outcome of healthcare delivery for both patient and surgeon." With the Platform, a surgeon can plan and validate the procedure before the patient arrives for surgery, thus minimizing the time spent in the operating room. For the patient there is the benefit of free movement and relatively greater comfort. And finally, for the hospital, the inexpensive custom Platform completely replaces the large stereotactic frame and cuts costs. Employees at FHC, a small company located in rural Maine, take the award in stride. "FHC has been serving the neuroresearch community for more than 35 years-developing new microelectrode configurations, amplifiers, and positioning devices to meet clients' evolving research needs", explains FHC president, Fred Haer, "and we have carried this design philosophy over into our clinical products." At first, FHC engineers simply tried to develop a new stereotactic device that was more comfortable and accurate, when they realized that they were working within the framework of a mechanical technology more than a century old. So, the team looked for a way to break down the frame. "We looked at emerging technologies and found in one a new way to design intelligent customized structures and in another the ability to manufacture them rapidly," Mr. Franklin explains, "and then created a custom interface with state of the art medical imaging and surgical planning software." Dr. Joel Franck, a Maine neurosurgeon and Mr. Franklin developed this innovative customized interface technology called STarFix (Surgical Targeting Fixtures). They believe that the unique customized fixtures can be utilized in other applications including spine and bone reconstruction surgeries. |
Two mT Platforms
can be used side by side,
FHC's team and the other 2004 MDEA winners will be honored at a ceremony this June at the Jacob Javits Convention Center in New York City where the Gold and Silver award recipients will be announced. |
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News
Release "Axon Instruments is recognized as a 'gold standard' instrument manufacturer in the research, neuroscience and biotech markets," Mike Graffam, FHC Engineering Manager, said while at the Axon Facility overseeing the inventory transfer. FHC Allen Groleau, added, "By adding the Guideline System to our stereotactic positioners, guidance systems, and technical support we will now be able to offer a complete, FDA cleared, procedural solution for targeting during movement disorder surgery." Axon Instruments, Inc., located in Union City, California and Melbourne, Australia, was founded in 1984. It produces a broad spectrum of instrumentation and software for genomics, cellular neurosciences and cell-based screening. In genomics and cellular neurosciences, Axon is already widely recognized as a pre-eminent manufacturer. The company's goal is to produce a range of superior yet affordable instrument and software systems for drug discovery ained at the pharmaceutical industry, biotechnology companies and academic researchers. Axon Instruments is a California corporation listed on the Australian Stock Exchange (symbol: AXN.AX). For more information, regarding
Axon products, please call Al Walter, PhD. (510) 675-6200 or
alw@axon.com. |
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FHC Adds ISO 9001:2000 Upgrade to MDD and FDA Certification Systems Bowdoinham, Maine, USA--Following the closing meeting of a company-wide audit conducted by ITS/SEMKO on August 21, 2002, FHC Quality System Officer Dr. Lee Margolin announced that the company had been recommended for ISO 9001:2000 certification. Companies that are currently compliant with the 1994 version of ISO 9001 are required to complete the upgrade by December 31, 2003 in order to maintain their certification. This represents a huge team effort, Dr. Margolin stated. Our eight person transition team has worked for the last 6 months to meet the new standard! The effort required a complete revision of the companys Quality Policy Manual as well as the revision of numerous procedure and process documents. This certification is significant because only 10% of the companies that are compliant with the 1994 ISO standard have achieved certification to the updated 2000 standard. The process was complicated by the fact that all changes had to be consistent with the FDAs Quality System Regulation as well as the European Unions Medical Device Directive to which the company is also certified. Human Resources Coordinator Ruth Harris explained, We are especially pleased because the new ISO standard emphasizes customer satisfaction, continuous improvement and the importance of our human resource assets in terms of both contribution and continual training. These have always been a priority at FHC and have enabled us to more than double our staff in three years. FHC, Inc. is located on the banks of the Cathance River in Bowdoinham, Maine. Its team of 44 designs, manufactures, and markets microelectrodes, electronics and mechanical instrumentation for research neuroscientists and clinical neurosurgeons worldwide. FHCs trademarks NeurocraftÔ and microTargeting™ proudly bear the Crafted in Maine to be the worlds best! statement. |
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microTargeting™ Drive System Introducing our elegantly simple microdrive for precise positioning of microelectrodes followed by DBS or lesion electrodes during functional neurosurgical procedures. Adaptors for most stereotactic systems are available, as well as insertion tube systems designed for quick and accurate electrode placement without time consuming measuring beforehand. The microTargeting™ Drive features a maTrix arrangement of guiding channels so that up to five tracks (on 2.00mm centers) can be mapped without adjustment of the stereotactic. |
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