The Game Changer for Tele-ICU (maybe) Here

 

Wake Med in Raleigh, NC only one in 2 sites in the US actively using the technology 

Israeli medical analytics startup Clew Medical announced this week that it received 510(k) clearance and authorization from the US FDA for the use of the Clew-ICU, the company’s artificial intelligence-based ICU solution, to predict hemodynamic (blood flow) instability in adult patients.

The clearance is the FDA’s first for such a device and follows the FDA’s Emergency Use Authorization (EUA) for Clew’s respiratory deterioration model granted in June 2020 for the predictive screening of COVID-19 and other ICU patients.

Founded in 2014, Clew develops real-time AI analytics platforms designed to help providers make better-informed clinical decisions by predicting life-threatening medical complications. Clew’s platform adjusts to cope with patient volume surges, reducing a caregiver’s exposure risk to infected patients, according to the company.

Clew-ICU monitors and categorizes patient risk levels, providing clinicians with physiological insight into a patient’s likelihood of future hemodynamic instability, the company says. The system provides notification of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention for prompt, proactive patient care.

The system also identifies low-risk patients who are unlikely to deteriorate, thus enabling better ICU resource management and optimization.

Clew-ICU receives patient data from various sources, including Electronic Health Record (EHR) data and medical device data, which is then analyzed in near real-time to present calculated insights and notifications.

“We are proud to have received this landmark FDA clearance and deliver a first-of-its-kind product for the industry, giving healthcare providers the critical data that they need to prevent life-threatening situations,” said Gal Salomon, Clew CEO.

“AI can be a powerful force for change in healthcare, enabling assessment of time-critical patient information and predictive warning of deterioration that could enable better informed clinical decisions and improved outcomes in the ICU,” said Dr. David Bates, Medical Director of Clinical and Quality Analysis in Information Systems at Mass General Brigham healthcare system in Boston and Clew Advisory Board member.

COVID-19: Guidance on Tocilizumab

NIH on tocilizumab: The National Institutes of Health has slightly upgraded tocilizumab as a treatment for COVID-19 in its latest COVID-19 treatment guidelines. Previously, the group recommended against the use of tocilizumab and other anti-interleukin-6 receptor monoclonal antibodies (e.g., sarilumab) outside of clinical trials. Now, citing conflicting evidence, the guideline panel says there are not enough data to recommend for or against the use of tocilizumab or sarilumab to treat COVID-19 in patients who have been admitted to the intensive care unit in the past 24 hours and require mechanical ventilation or high-flow oxygen. Some panel members, citing the REMAP-CAP trial, say that for patients who meet the above criteria and have rapid progression of respiratory failure, they would administer a dose of tocilizumab (8 mg/kg of body weight, up to 800 mg) plus dexamethasone. For patients who don't require ICU care, the panel continues to recommend against these drugs.

NIH COVID-19 Treatment Guidelines update (Free)

The Lancet Public Health article on testing frequency (Free abstract)

NEJM Journal Watch COVID-19 page (Free)

NEJM COVID-19 page (Free)

Not all DOACs are created equily

RCTs     see link for article discussed 

Although phase III clinical trials provide the highest-quality level of evidence it is important to have results from observational real-life cohort studies, as patients in daily clinical practice may substantially differ from those included in RCTs, in terms of comorbidities as very elderly or patients with cancer or advanced chronic and liver disease are usually excluded or under-represented. Furthermore, patients included in RCT are usually strictly monitored and length of follow-up is usually 

Again , a confirmation that the external validity of RCTs is limited and real life follow up data a necessary. All DOACs have been compared to VKA , but not against each other .