medical testing News
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Enterprise Forum
The 101 Corridor is leading the way in new diagnostics that will bring information to you and your doctor within minutes or hours. You will no longer have to wait for days for a central diagnostic laboratory to provide critical medical test data regarding your health. This program showcases a range of young diagnostic companies that are poised to launch exciting products and services that will ...
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Formal System Testing for Medical Devices – Part 2
Verification is critical for medical device testing, which is why we recommend reading part one if you haven’t already. In part one of this series, we examined the need for medical testing and briefly covered the first few aspects of device verification. In this article, we’ll cover the verification dry run and the formal verification process that makes new medical products a reality. ...
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A French start-up harnesses the power of the latest generation genomic sequencers to dramatically increase COVID 19 testing capacity
SeqOne Genomics, a start-up specialized in genomic analysis software, is partnering with leading medical testing labs to develop an approach that delivers up to 100 times more COVID 19 tests per machine thanks to NGS sequencers. Epidemiological experts agree that the key to successfully managing the COVID 19 pandemic is a robust national testing capability that can dispense hundreds of thousands ...
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Element Acquires EMV Testhaus to Expand its Position in the German Automotive and Medical Testing Markets
Element Materials Technology (Element) has acquired the product testing company EMV Testhaus GmbH to strengthen its position in the German automotive and medical markets. Founded in 1991 by Charlotte Klein and Rudolf Klein, EMV Testhaus specialises in EMC, wireless, product and safety testing, and has customers across a wide range of industries including IoT, medical and automotive. EMV ...
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Levmed Hospital Grade 12 Lead ECG assessment Anywhere by Anyone
A 12 Lead Rest ECG is a basic medical test used to detect signs of cardiac problems. Based on these signs medical treatment can be given. Levmed brings hospital-grade 12 Lead cardiac assessment anywhere in the world. Levmed 12 Lead ECG Electrodes belt replaces the vacuum pumps electrodes or patch electrodes. The advantages of using Levmed 12 Lead ECG Electrodes belt are: Ease of use can ...
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Modular Medical Announces Product Testing Update
Modular Medical, Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), a development stage, insulin delivery technology company seeking to launch the next generation of easy to use and affordable insulin pump technology, today announced an update on the development of its initial insulin pump product. The Company has continued to make progress on the testing required for its 510(k) submission ...
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Fretting Corrosion Causes Recall of Drug Delivery Medical Device
This past November, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ikaria INOmax DS Drug Delivery System. The device is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients. According to the FDA posting regarding the recall, “Fretting corrosion at the ...
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XPhyto Signs Letter of Intent for US Manufacturing and Strategic Business Opportunities
XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to report that it has signed a non-binding Letter of Intent (“LOI”) to identify and assess potential business synergies for manufacturing, import/export, distribution and product development with a US-based thin film manufacturing firm (the “Firm”). ...
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Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show
Babson Diagnostics, a science-first, health care technology company, today announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular ...
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STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
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ASTM D5151 - 06(2011) Standard Test Method for Detection of Holes in Medical Gloves
This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove. This test method is suitable and designed as a reference method to evaluate samples of medical gloves. 1. Scope 1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the ...
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STEMart Launches Bioburden and Sterility Testing for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method. For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of ...
By STEMart
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Eurofins Biomnis and Seqone Partner to Improve Clinical Access to Whole Exome Testing
Eighty percent of rare diseases are genetic in origin and result from a small number of genetic mutations. Identifying these variations is essential in diagnosing the diseases and can dramatically improve patient care. Making Whole Exome sequencing more affordable to improve diagnostic efficiency Since 2017, Eurofins Biomnis has offered “Whole Exome” sequencing which, starting from ...
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ASTM F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
The shear test method is recommended for shear testing of calcium phosphate and metallic/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under a uniaxial shear stress. The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Information developed using this test method may be ...
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STEMart Launches Biological Indicator Sterility Testing Service for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can ...
By STEMart
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ASTM D6124 - 06(2011) Standard Test Method for Residual Powder on Medical Gloves
This test method is designed to determine the amount of residual powder and non-powder solids found on medical gloves. This test method is suitable and designed as a reference method to evaluate samples of medical gloves. The mass found using Procedure II, for powdered gloves, is assumed to be a combination of water-insoluble residue remaining after the manufacturing process, ...
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XPhyto Pursues Potential Application of its Oral Dissolvable Biosensor Inflammation Test for Buprenorphine-related Dental Disease
XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to report a significant potential market opportunity for its oral dissolvable (“ODF”) biosensor screening tests for oral inflammation. Certain buprenorphine medicines prescribed to treat opioid use disorder (“OUD”) and pain have been recently associated ...
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Diasorin launches Liaison MeMed BV, the first high throughput blood test to differentiate between bacterial and viral infections, in countries accepting the CE Mark
Liaison Memed Bv is an immune system based protein signature test for distinguishing between bacterial and viral infections The test was developed following the licensing agreement signed with Memed as announced in September 2020 The new test is available on the Liaison Xl platforms in countries that accept CE mark and U.S. food and drug administration clearance is planned for 2022 ...
By MeMed
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ASTM F1160 - 05(2011)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress. In order ...
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STEMart Launches New Force Degradation Services to Ensure Drug Stability and Safety
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout their shelf life. Forced ...
By STEMart
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