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ReCor Medical announced that its Paradise ultrasound renal denervation system has met its primary efficacy endpoint in a pivotal clinical trial as a treatment for hypertension. Read More
An artificial intelligence (AI) platform that evaluated early signs of infection in hospitalized patients reduced death from sepsis by more than 18 percent, according to researchers at Johns Hopkins University. Read More
Medical device trade group AdvaMed and dozens of diagnostics and device firms are urging Congress to include diagnostics reform provisions in the FDA user fee reauthorization package that is currently awaiting a Senate vote. Read More
DiaSorin gained the rights to commercialize the test for use on its Liaison analyzer platform in the U.S. in a September 2020 licensing deal with MeMed. Read More
A Failure Modes Effects and Criticality Analysis (FMECA) begins with planning — and the FMECA plan should define the objectives and scope of the analysis and identify the desired outcome. Read More
More than 85 percent of previously certified devices in the EU are not yet certified under the Medical Device Regulation (MDR) and the certification process is taking twice as long as it used to, according to a new MedTech Europe survey. Read More
Biotronik has agreed to pay almost $13 million to settle allegations that it paid kickbacks to physicians to encourage their use of the company’s implantable cardiac devices. Read More