Received: 4 February 2022
Accepted: 16 May 2022
First Online: 7 July 2022
: It was determined that the project does not require IRB approval because it is not regulated research as defined by DHHS regulations at 45 CFR 46 and FDA regulations at 21 CFR 56. The proposed activity is not funded by DHHS as research; AND is not a systematic investigation to test a hypothesis and permit conclusions to be drawn; AND is not designed to develop or contribute to generalizable knowledge; AND the purpose is not to investigate the safety or effectiveness of a drug, medical device or biologic.
: All authors and editors consent to the publication of this data.
: Echonous, Philips, General Electric, and Butterfly Network, Inc. did not have any involvement in the development of this study, data review and analysis, writing of the manuscript, or any approval or decision making in the submission of this manuscript. None of the authors are or were in any contractual agreement with Echonous, Philips, General Electric, or Butterfly Network, Inc. regarding the study equipment (other than purchasing or loan agreements). None of the authors serve as speakers or consultants for any of the companies whose devices were included in this study. The authors did not receive any payment, support, or benefits from these companies for the present study or in the past. The Kosmos™ (Echonous), Lumify™ (Phillips), and Vscan Air™ (General Electric) ultrasound equipment were temporarily loaned from their respective companies at the request of one of our authors (NS). The Butterfly IQ+™ (Butterfly Network, Inc.) equipment was previously purchased by one of our authors (GJ) for personal use and temporarily loaned for this study. One of the authors (HS) has received loaned equipment with shipping from Butterfly Network, Inc. for an unrelated investigator-initiated study.