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The number of countries to which the EU's MDR and IVDR will apply totals 33. But the regulations will impact many more markets than that, according to Erik Hansson, deputy head of the European Commission unit that oversees medical devices. See what he said here.
US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.
Matteo Lai, CEO of a company that makes the first US FDA-cleared seizure-monitoring smart watch, says users don't care much about artificial intelligence or fancy technology. Rather, they simply want the device to be easy to use and to do its job. See what Lai said about it here.
Abbott Laboratories pointed to success in its electrophysiology device business last quarter, driven by multiple products including the Confirm Rx insertable cardiac arrhythmia monitor, which the firm says is the thinnest in class, and is smartphone-compatible for more direct patient engagement. See what Abbott VP Ari Fischer says about it here.
When ALung Technologies was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into. See what ALung CEO Pete DeComo said about the pathway – now called the Breakthrough Devices Program – here.
RedMed Inc. is continuing to invest aggressively in its "software-as-a-service" offerings with the addition of MatrixCare, a provider of long-term post-acute care software. See what MatrixCare CEO John Damgaard said about it here.
David Boudreau, chair of the committee that oversees the Medical Device Single Audit Program (MDSAP), believes "instability" could come to the device industry if international quality systems standard ISO 13485 is retooled right now. See what he wrote to the International Organization for Standardization (ISO) here.
Despite the most recent version of ISO 13485 not even going into effect for another four months, the International Organization for Standardization (ISO) Technical Management Board is already looking to open up the international quality systems standard for a rewrite. See what NSF International's Kim Trautman said about it here.
GNS Healthcare and its REFS (Reverse Engineering, Forward Simulation) AI platform is at the forefront of bringing targeted artificial intelligence solutions to biopharmaceutical companies, health plans and research organizations by helping to support better decision-making, better outcomes and cost savings. See what GNS cofounder Iya Khalil said about it here.
With 25 device and diagnostics start-ups in its portfolio, the Pittsburgh Life Sciences Greenhouse aims to establish life-sciences companies in Western Pennsylvania by leveraging the area's top schools and best-in-class medical facilities. See what the Greenhouse's Harold Safferstein said about it here.
With disruptive pressures from tech players like Apple and retail giants like Amazon, the push for device-makers to engage patients more directly with the help of data analytics and digital tools is high. But digital-health specialist John Nosta urges medtech firms to remember where their real expertise lies. See what he said here.
Medical Device Single Audit Program auditor Brian Ludovico says it's vitally important for a device firm's regulatory and quality departments to get along if they're going to ace an MDSAP audit. See what Ludovico, who is with consulting firm NSF International, said about it here.
A so-called "CFL" (Consistent with FDA Labeling) guidance document finalized by the US agency in June gave manufacturers more freedom to discuss devices in ways not specifically included in the labeling, but FDA and industry are still feeling out the limits of the protection. See what Medtronic attorney Cassie Scherer said about it here.
A key goal for Bay Labs Inc.'s EchoGPS and EchoMD imaging devices is to empower non-specialist users who don't have specialized training and certification in echocardiography – such as medical assistants, nurses, physician assistants or physicians – by providing real-time guidance. See what company cofounder and CEO Charles Cadieu said about the products here.
A US Supreme Court ruling expected this fall on Merck v. Albrecht could shed light on how new Justices Brett Kavanaugh and Neil Gorsuch will view issues related to federal preemption. See what Washington Legal Foundation's Glenn Lammi said about the case here.
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