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BioWorld - Sunday, April 26, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Regulatory front for Aug. 17, 2020

Aug. 17, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Cartiva, C.R. Bard, Stryker ENT.
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Regulatory actions for Aug. 17, 2020

Aug. 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter.
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Hospital patient, device image

Masimo gets FDA nod for fluid responsiveness indicator

Aug. 14, 2020
By Meg Bryant
The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle.
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Regulatory front for Aug. 14, 2020

Aug. 14, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: RS Medical.
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Regulatory actions for Aug. 14, 2020

Aug. 14, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo.
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Globe showing Asia-Pacific region

‘Made-in’ policies for medical devices spreading across Asia-Pacific region

Aug. 13, 2020
By Mark McCarty
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
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Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 13, 2020
By Mari Serebrov
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
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Regulatory front for Aug. 13, 2020

Aug. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular Therapeutics, Bayer, Hyperfine, Inmode, Osprey Medical, Quidel, RapidAI, Spectronrx.
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