MedTech Dive - Latest News /news/MedTech industry newsen-usWed, 24 Jun 2020 15:32:58 -0400Fauci: Trump never asked to slow down testing, says US needs more, not less /news/fauci-trump-never-asked-to-slow-down-testing-says-us-needs-more-not-less/580446/<p>During a House panel Tuesday, top U.S. infectious disease doctor&nbsp;Anthony Fauci and other&nbsp;public health officials denied they&#39;d been directed to impede testing efforts as the White House targets&nbsp;up to&nbsp;50 million tests a&nbsp;month by&nbsp;fall.</p>Rebecca PiferWed, 24 Jun 2020 15:32:58 -0400/news/fauci-trump-never-asked-to-slow-down-testing-says-us-needs-more-not-less/580446/5-minute, quantitative COVID-19 antibody test snags BARDA backing /news/coronavirus-mbio-rapid-quantitative-antibody-test-barda/580420/<p>MBio&#39;s offering could assess whether a patient has protective levels of antibodies and is a candidate to donate convalescent plasma,&nbsp;a potential treatment for&nbsp;critically ill COVID-19 patients.</p>Susan KellyWed, 24 Jun 2020 10:00:00 -0400/news/coronavirus-mbio-rapid-quantitative-antibody-test-barda/580420/CVS launches COVID-19 return-to-work service with testing /news/cvs-launches-return-to-work-service-including-in-house-covid-19-testing-op/580455/<p>Questions about testing accuracy and hesitancy by employers haven&#39;t stopped big healthcare companies, including Quest,&nbsp;LabCorp and UnitedHealth Group, from jumping into the space with new products.</p>Rebecca PiferWed, 24 Jun 2020 08:44:59 -0400/news/cvs-launches-return-to-work-service-including-in-house-covid-19-testing-op/580455/Baxter, B. Braun infusion pumps among millions of devices implicated in Ripple20 cyber alert /news/baxter-b-braun-infusion-pumps-among-millions-of-devices-implicated-in-rip/580429/<p>Despite warnings that a remote hacker could gain control of a pump, medtechs affected by the vulnerabilities&nbsp;described&nbsp;it as low risk and manageable.</p>Greg SlabodkinWed, 24 Jun 2020 08:42:31 -0400/news/baxter-b-braun-infusion-pumps-among-millions-of-devices-implicated-in-rip/580429/New Guardant genomic database could be worth $2B, analysts say /news/new-guardant-genomic-database-could-be-worth-2b-analysts-say/580419/<p>The company said clinical information&nbsp;from repeat liquid biopsies in its&nbsp;86,000-patient database will show how tumors evolve, information that may be attractive to&nbsp;biopharma partners.</p>Nick Paul TaylorWed, 24 Jun 2020 04:03:05 -0400/news/new-guardant-genomic-database-could-be-worth-2b-analysts-say/580419/Medtronic Evolut TAVR system gets expanded label in Europe /news/medtronic-evolut-tavr-system-gets-expanded-label-in-europe/580326/<p>New indications allow&nbsp;a less-invasive&nbsp;alternative to traditional open heart surgery for&nbsp;a group of severe aortic stenosis patients who tend to be younger and more active, and in higher-risk patients with bicuspid aortic valves.</p>Susan KellyTue, 23 Jun 2020 10:00:00 -0400/news/medtronic-evolut-tavr-system-gets-expanded-label-in-europe/580326/FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels /news/fda-reiterates-potential-to-miss-mdufa-deadlines-still-weighing-virtual-ad/580330/<p>Separately, the agency announced virtual meetings in September on using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in evaluating devices.</p>Nick Paul TaylorTue, 23 Jun 2020 05:45:34 -0400/news/fda-reiterates-potential-to-miss-mdufa-deadlines-still-weighing-virtual-ad/580330/Mainstay wins FDA approval for chronic back pain device following mixed clinical data /news/mainstay-wins-fda-approval-for-chronic-back-pain-device-following-mixed-cli/580327/<p>The premarket approval comes 19 months after the ReActiv8 neurostimulation system failed a clinical trial aimed at generating&nbsp;data to break into the U.S. market.</p>Nick Paul TaylorTue, 23 Jun 2020 04:31:25 -0400/news/mainstay-wins-fda-approval-for-chronic-back-pain-device-following-mixed-cli/580327/BARDA backs study of Empatica's COVID-19 early warning platform /news/barda-backs-study-of-empaticas-covid-19-early-warning-platform/580227/<p>The&nbsp;system, which measures physiological data including blood volume pulse and&nbsp;electrodermal&nbsp;activity, is the latest in a growing list of wearables being primed to detect and monitor infections.</p>Susan KellyMon, 22 Jun 2020 10:00:00 -0400/news/barda-backs-study-of-empaticas-covid-19-early-warning-platform/580227/No silver bullet: LabCorp and Quest hawk return-to-work COVID-19 tests but employers not rushing in /news/no-silver-bullet-labcorp-and-quest-hawk-return-to-work-covid-19-tests-but/580119/<p>One employer group official noted &quot;hype&quot; around antibody testing with inconclusive evidence about the immunity of individuals who test positive for the antibodies.&nbsp;</p>Greg SlabodkinMon, 22 Jun 2020 10:00:00 -0400/news/no-silver-bullet-labcorp-and-quest-hawk-return-to-work-covid-19-tests-but/580119/