Author Archives: Andrea Gonzalez

Four NIH-backed artificial pancreas pivotal trials are slated to begin soon

By Stacy Lawrence, Staff Writer Intensive efforts to improve artificial pancreas technology continue apace even as Medtronic plc prepares to launch the first FDA-approved iteration by this summer. The National Institutes of Health (NIH) is highlighting four pivotal trials that…

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Flow Forward raises $7M in series A funding for hemodialysis AFE pump

By Omar Ford, Staff Writer Med-tech startup Flow Forward LLC said it has raised a total of $7 million in its series A round. The news comes around the same time the private company reported completing two studies evaluating its…

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Intensix brings in $8.3M in series A to incorporate ‘big data’ solution in ICU

By Omar Ford, Staff Writer Health care data analytics start-up Intensix Ltd. brought in $8.3 million in its series A funding round. The Netanya, Israel-based company has developed a real-time predictive analytics platform for the early detection of patient deterioration…

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Carmat suspends pivotal trial for artificial heart in face of expanded regulatory scrutiny

By John Brosky, Contributing Writer PARIS – In the face of an expanded scope of scrutiny by French health authorities triggered by the death of the first patient in the pivotal trial for its artificial heart, Paris-based Carmat SA reported…

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Corus coronary artery disease test from Cardiodx fares well in PROMISE trial

By Omar Ford, Staff Writer Cardiovascular genomic’s specialist Cardiodx Inc.’s test to detect obstructive coronary artery disease (CAD) received long-term validation from a study published in this month’s American Heart Journal. The Corus CAD test was evaluated in a genomic…

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Elekta secures FDA clearance for Venezia cervical cancer treatment device

By Omar Ford, Staff Writer Elekta AB has received FDA clearance for its Venezia applicator for gynecological brachytherapy. The device is positioned to treat advanced-stage cervical cancer and has had a CE mark since last year. The Stockholm-based company said…

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FDA adds whole blood Zika detection to Abbott’s emergency use authorization

By Stacy Lawrence, Staff Writer The U.S. Food and Drug Administration has given its first nod to a molecular test developed by Abbott Laboratories for the Zika virus for use to test whole blood. This expands upon an existing use…

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Medtronic stays on course with FDA nod for Cardioinsight mapping system

By Omar Ford, Staff Writer Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of…

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Pro-Dex puts emphasis back on devices with the sale of its OMS Motion division

By Omar Ford, Staff Writer Pro-Dex Inc. said it is selling its Oregon Micro Systems division to Beaverton, Ore.-based Oms Motion Inc. The Irvine, Calif.-based company’s division designs embedded multiaxis motion controllers, which are sold to distributors or original equipment…

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Mallinckrodt continues march towards pure-play pharma status with pair of divestitures

By Omar Ford, Staff Writer Mallinckrodt plc has closed on a $690 million deal to sell its nuclear imaging business to St. Louis-based Iba Molecular Corp. The deal was first disclosed back in August of last year. The Staines-upon-Thames, U.K.-based…

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