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Monitoring Tech Dominates Recent Breakthrough Device Designations

by | Mar 7, 2022 | Articles, News, Open Content

In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include monitoring devices: Recent Breakthrough Device Designations 23: Noninvasix announces breakthrough device designation for its […]

In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include monitoring devices:

Recent Breakthrough Device Designations

  • 23: Noninvasix announces breakthrough device designation for its LIVOx™ Central Venous Oxygenation Monitor that provides non-invasive, real-time, continuous, or spot monitoring of central venous oxygen saturation (ScvO2) in adults at risk of septic shock
  • March 1: DexCom, Inc. announces breakthrough device designation for the use of its Dexcom continuous glucose monitoring (CGM) system for use in a hospital setting
  • March 1: The non-monitoring related breakthrough device announcement comes from AltPep Corporation, which gained breakthrough device designation for its SOBA-AD blood test to detect Alzheimer’s Disease

Recent FDA Approvals

While it didn’t receive breakthrough designation, another monitoring device, Masimo’s SedLine® for monitoring brain function in patients one to 17 years of age, and the company’s SedLine Pediatric EEG Sensor, received FDA clearance on Feb. 18.

In other FDA approvals for the period, on March 2, French medical technology company Gleamer gained FDA approval for its BoneView® artificial intelligence software to help detect and localize fractures. The system achieved CE mark class 2a certification in the European Union in March 2020 and is used in more than 300 institutions in 13 different countries, according to a company statement.

Recent Emergency Use Authorizations

Unsurprisingly, COVID-19 tests made up all the Emergency Use Authorizations (EUAs) during this period:

  • 23: ChromaCode’s EUA for its HDPCR™ SARS-CoV-2 assay was expanded by the FDA to include several new qPCR instruments and use of 384-well plates
  • 23: Assurance Scientific Laboratories received EUA for its Assurance SARS-CoV-2 Panel DTC and Assurance SARS-CoV-2 Panel
  • 23: The Yale School of Public Health, Department of Epidemiology of Microbial Diseases received EUA for its SalivaDirect DTC Saliva Collection Kit and SalivaDirect for use with DTC Kits
  • 28: Oceanit Foundry received EUA for its ASSURE-100 Rapid COVID-19 Test
  • March 1: Thermo Fisher Scientific received EUA for its TaqPath COVID-19 RNase P Combo Kit 2.0
  • March 1: The Yale School of Public Health, Department of Epidemiology of Microbial Diseases received EUA for its SalivaDirect At-Home Collection Kit
  • March 1: Cue Health received EUA for its Cue COVID-19 Test
  • March 2: Intrivo announced the launch of its On/Go One™ rapid COVID-19 test, which recently gained EUA approval

ChromaCode claims the expanded EUA it received will allow its test to potentially more than quadruple throughput for labs, while Intrivo states its On/Go One rapid test can detect all major known variants in 15 minutes while offering 98.2 percent accuracy.

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