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108 - Erdafitinib for urothelial cancer; Blood test for infection-causing pathogens; Clearances for noninvasive ventilation (NIV) mask access elbow, new fluoroscopy system, and multi sperm separation devices; FDA statement on lowering nicotine levels in c
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March 16, 2018
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1:34 FDA breakthrough therapy designation for Erdafitinib in the treatment of metastatic urothelial cancer https://www.prnewswire.com/news-releases/janssen-announces-us-fda-breakthrough-therapy-designation-for-erdafitinib-in-the-treatment-of-metastatic-urothelial-cancer-300614532.html
3:00 Breakthrough device designation for infection-causing pathogen blood test https://www.prnewswire.com/news-releases/3i-diagnostics-receives-breakthrough-device-designation-from-fda-for-technology-that-identifies-infection-causing-pathogens-directly-from-blood-in--1-hour-300614678.html
3:54 FDA grants clearance for ReddyPort's NIV access elbow https://www.prnewswire.com/news-releases/food-and-drug-administration-grants-clearance-for-reddyports-niv-access-elbow-300614253.html
5:38 Philips receives U.S. FDA 510(k) clearance to market ProxiDiagnost N90, its premium digital radiography and nearby fluoroscopy system https://www.prnewswire.com/news-releases/philips-receives-us-fda-510k-clearance-to-market-proxidiagnost-n90-its-premium-digital-radiography-and-nearby-fluoroscopy-system-300614478.html
6:35 DxNow, Inc. receives FDA 510(k) clearance for ZyM?t™ ICSI and ZyM?t™ multi sperm separation devices https://www.prnewswire.com/news-releases/dxnow-inc-receives-fda-510k-clearance-for-zymt-icsi-and-zymt-multi-sperm-separation-devices-300614195.html
8:22 Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels https://www.fda.gov/newsevents/newsroom/pressannouncements/default.htm
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