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The test showed a sensitivity of 99.1 percent for correctly identifying positive samples and a specificity of 99.6 percent for accurately detecting negative samples. Read More
“Physiological assessment of the bones and joints has obvious advantages, but getting this data via multiplanar imaging enables accurate road maps for effective surgical planning,” said Sajid Butt, a consultant radiologist at the UK’s Royal National Orthopedic Hospital-Stanmore. Read More
The automation-friendly test takes less than two hours to deliver results and requires fewer steps, reducing the chances of human error, Omixon said. Read More
The FDA cited six devicemakers for problems found during inspections of their facilities, including inadequate validations, medical device reporting and investigations into complaints. Read More
Australia’s Therapeutics Goods Agency (TGA) has issued a new paper on its plan to establish a unique device identification (UDI) system and it wants to hear reactions from device sponsors. Read More
The FDA has updated its electronic medical device reporting (eMDR) system to include new fields for summary reports and combination products to harmonize with international reporting codes. Read More
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body. Read More