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The New Medtech Regulations Will Take Effect October 1
Aug 18, 2014Medtech regulatory consultants and manufacturers are working to interpret the new medtech regulations promulgated in the People's Republic of China. The new regulations, designed to boost supervision and administration of medical devices, ...
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Medtech Manufacturers May Soon Have Clearer Guidelines on How to Get Their Products
Aug 14, 2014Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA’s 510(k) process—with the changes meant to address the widespread criticism of the regulatory pathway in recent years by ...
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FDA Provides MDIC with $500,000 to Conduct Research to Understand Patient Preferences
Apr 28, 2014The FDA is providing the Medical Device Innovation Consortium (MDIC) with nearly $500,000 to conduct research to better understand patient preferences, and how to integrate such preferences into the development of medical devices, the group ...
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84% of Devices Had Not Been Tested on Any Child Before The Approval Was Granted.
Apr 14, 2014A study of 25 high-risk medical devices approved for use on children showed that 84 percent of those devices approved by FDA since 2008 had not been tested on any child under 18 years of age before the approval was granted. Eleven had not ...
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High Point's Premarket Will Take Place Here March 3-4 with 24 Exhibitor Sponsors
Mar 5, 2014HIGH POINT — High Point's Premarket will take place here March 3-4 with 24 exhibitor sponsors, the High Point Market Authority has announced. Premarket takes place about a month before the spring and fall High Point Market and gives ...
Tags: High Point Premarket Set
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Developing Oncology Companion Diagnostic Test Was Agreed by Amgen and Illumina
Jan 17, 2014Illumina has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of ...
Tags: Amgen, FDA, CE, Illumina Oncology
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FDA 510(K) Approval for Microcutter Xchange 30 Cutting/Stapling Device Is Got by Cardica
Jan 13, 2014Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue. The company has designed the ...
Tags: Cardica, medical device
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Integra Lifesciences Has Announced The Completion of Patient Enrollment
Dec 25, 2013Integra LifeSciences, has announced the completion of patient enrollment in a pivotal clinical trial designed to assess the safety and effectiveness of Integra dermal regeneration template in the treatment of diabetic foot ulcers. Integra ...
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510(K) Premarket Notification Is Signed by Corgenix Medical with FDA for Txbcardio Assay
Dec 18, 2013Corgenix Medical, in collaboration with Randox Laboratories, has filed first 510(k) premarket notification with the US Food and Drug Administration (FDA) for the TxBCardio immunoturbidimetric assay. According to Corgenix Medical, ...
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Philips Is Offering Free Replacement of The Devices
Dec 5, 2013A faulty electronic component in some Philips HeartStart automated external defibrillators may prevent the device from delivering a needed shock to a person suffering a cardiac emergency, the FDA recently warned. The Dutch multinational's ...
Tags: Philips Defibrillator, FDA
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Barnes & Noble Returned to a Profit in The Fiscal Second Quarter
Nov 27, 2013Barnes & Noble returned to a profit in the fiscal second quarter as it invested less in its Nook e-book reader and cost cuts offset lower sales. Its sales missed expectations, however, and its shares dropped more than 3 percent in ...
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FDA Halted The Selling of The 23andMe Saliva Collection Kit
Nov 27, 2013The U.S. Food and Drug Administration halted the selling of the 23andMe Saliva Collection Kit and Personal Genome Service -- a home DNA test. In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or ...
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Illumina Has Obtained Premarket Clearance From FDA for The Miseqdx System
Nov 22, 2013US-based Illumina has obtained premarket clearance from the US Food and Drug Administration (FDA) for the MiSeqDx system, a high-throughput DNA sequencing analyzer. The company has also obtained premarket clearance from the FDA for the ...
Tags: Illumina, MiSeqDx System
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Salix Has Approved The Deflux Premarket Approval (PMA) Supplement
Nov 20, 2013US-based Salix Pharmaceuticals has announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux premarket approval (PMA) supplement, which requested approval of ...
Tags: Salix, Injection Techniques
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Neuropace Has Received FDA Premarket Approval for Its Neuropace RNSSystem
Nov 18, 2013US-based NeuroPace has received the US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, designed to treat partial onset seizures that have not been controlled with two or more antiepileptic medications in ...
Tags: RNS System, NeuroPace