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UK-based Motilent has partnered with Nuance Communications, a Microsoft subsidiary based in Burlington, Mass., that markets AI software and speech recognition products. Read More
Eurobio’s EBX 047 test is a multiplex PCR kit to identify the presence of the SARS-CoV-2 virus that causes COVID-19 and qualitatively distinguish between several mutations. Read More
The FDA has classified the marker as a Class II device that requires special controls to provide “reasonable assurance of the safety and effectiveness.” Read More
Citing the COVID-19 pandemic and other obstacles, the European Union has pushed back the dates by which manufacturers must comply with the EU’s IVD Medical Devices Regulation (IVDR). Read More
The LumiHeal System is a noninvasive, nonthermal treatment that employs fluorescent light energy for reducing the appearance and feel of acute postsurgical incisions. Read More
The new version of ViewRay’s MRIdian software also includes a new brain treatment package expanding its clinical utility into cranial stereotactic radiosurgery and stereotactic radiation therapy. Read More
The European Commission has issued a regulation that will allow devicemakers to distribute instructions for use (IFUs) in electronic format, playing catch-up with the FDA and other international regulatory agencies that have already allowed devices to be accompanied by electronic-only instead of paper instructions. Read More