Medtech in a Minute: COVID-19 Fraud, a Virtual AFib Trial, and More

FDA Cracks Down on Fraudulent COVID-19 Tests The agency revised its earlier policy on COVID-19 antibody tests to cut down on false and inappropriate marketing claims that have cropped up. In March it was critical for FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency. But officials said this week that flexibility never meant they would allow fraud.   Now May Not Be the Best Time for an IPO Pulmonx was poised to go public but the global pandemic forced the company to switch gears. Still, Pulmonx managed to raise $66 million to support the commercialization of its minimally invasive treatment for severe emphysema. Fitbit Launches a Virtual AFib Study The large-scale study, intended to validate the use of Fitbit's wearable technology for atrial fibrillation detection, is expected to enroll hundreds of thousands of people. The company said its wearables have the potential to accelerate AFib detection thanks to 24/7 heart rate tracking powered by a long battery life. Click here to listen to the podcast version of Medtech in a Minute
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

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Source: BMJ Comments - Category: General Medicine Source Type: forums
No abstract available
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Editorials Source Type: research
No abstract available
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Editorials Source Type: research
CONCLUSIONS: Despite the significant variability in frequency and duration of prone positioning and respiratory supports applied, prone positioning was associated with improvement in oxygenation variables without any reported serious adverse events. The results are limited by a lack of controls and adjustments for confounders. Whether this improvement in oxygenation results in meaningful patient-centered outcomes such as reduced intubation or mortality rates requires testing in well-designed randomized clinical trials.
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Clinical Investigations Source Type: research
OBJECTIVES: To determine if a restrictive visitor policy inadvertently lengthened the decision-making process for dying inpatients without coronavirus disease 2019. DESIGN: Regression discontinuity and time-to-event analysis. SETTING: Two large academic hospitals in a unified health system. PATIENTS OR SUBJECTS: Adult decedents who received greater than or equal to 1 day of ICU care during their terminal admission over a 12-month period. INTERVENTIONS: Implementation of a visit restriction policy. MEASUREMENTS AND MAIN RESULTS: We identified 940 adult decedents without coronavirus dis...
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Brief Report Source Type: research
No abstract available
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Letters to the Editor Source Type: research
CONCLUSIONS: Circulating immune cells profile differs between mild and severe coronavirus disease 2019 patients. Severe coronavirus disease 2019 is associated with a unique immune profile as compared with sepsis. Several immune features are associated with outcome. Thus, immune monitoring of coronavirus disease 2019 might be of help for patient management.
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Clinical investigations Source Type: research
OBJECTIVES: We performed a comprehensive health assessment in mechanically ventilated coronavirus disease 2019 survivors to assess the impact of respiratory and skeletal muscle injury sustained during ICU stay on physical performance at 3 months following hospital discharge. DESIGN: Preregistered prospective observational cohort study. SETTING: University hospital ICU. PATIENTS: All mechanically ventilated coronavirus disease 2019 patients admitted to our ICU during the first European pandemic wave. MEASUREMENTS AND MAIN RESULTS: At 3 months after hospital discharge, 46 survivors underwent a...
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Clinical investigations Source Type: research
In this study, we sought to retrospectively validate this protocol to cohorts of critically ill patients from our hospital. DESIGN: We applied our hospital-adopted guidelines, which defined severe and major chronic conditions as those associated with a greater than 50% likelihood of 1- and 5-year mortality, respectively, to a critically ill patient population. We investigated mortality for the same intervals. SETTING: An urban safety-net hospital ICU. PATIENTS: All adults hospitalized during April of 2015 and April 2019 identified through a clinical database search. INTERVENTIONS: None. MEASU...
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Clinical investigations Source Type: research
OBJECTIVES: Nonpharmaceutical interventions are implemented internationally to mitigate the spread of severe acute respiratory syndrome coronavirus 2 with the aim to reduce coronavirus disease 2019–related deaths and to protect the health system, particularly intensive care facilities from being overwhelmed. The aim of this study is to describe the impact of nonpharmaceutical interventions on ICU admissions of non–coronavirus disease 2019–related patients. DESIGN: Retrospective cohort study. SETTING: Analysis of all reported adult patient admissions to New Zealand ICUs during Level 3 and...
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Clinical investigations Source Type: research
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