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This week we will be covering updates on Covid-19, new FDA guidance on digital health technology, and cancer-focused healthcare startups
Covid-19 Updates Around the World
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Omicron continues to spread rapidly causing a rise in cases globally, with nearly 4.99 million new cases from Christmas week.

In the U.S., the new daily case total topped 488,000. Amidst this spike in cases, schools and workplaces are shifting back to virtual spaces. Several college campuses including the University of Chicago and MSU are holding remote classes for the first few weeks of the semester. 

In Israel, Health Ministry Director General Nachman Ash predicts that the surge of cases could lead to herd immunity in the country but at a cost. Models show that up to four million people may be infected by the end of January.

Europe accounts for half of the new Covid-19 cases. France, Germany, and Greece imposed stricter regulations for early January amidst this rise. France limited public gatherings to 2,000 people indoors and 5,000 people outdoors; Germany limited private, vaccinated gatherings to 10; and Greece imposed midnight curfews. However, the U.K did not follow suit, instead urging the public to voluntarily undertake safety measures. 

 FDA Guidance on Digital Health Technology
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New FDA guidance discusses how digital tools can be used in clinical trials to safely collect data from patients. This comes in a time when the use of sensors and connected medical devices is increasing in clinical trials. The draft guidance is particularly important for FDA-regulated research by companies or institutions, as well as for institutional review boards and research sites. 

It provides guidance along the axes of verification, validation, and usability of digital health technologies. Verification means to demonstrate that the characteristic being assessed by the technology is consistently and appropriately measured, and confirms that performance standards are met. Validation may involve comparisons to reference measurements and evaluation of factors that affect precision and accuracy such as calibration. The guidance also breaks down potential risks, including clinical risks, privacy risks, and informed consent risks

Stakeholders are able to comment on the guidance until March 23rd, 2022.

BLUEPRINTS SPOTLIGHT

Shreya is the Chief of Expansion and is currently a sophomore on the Pre-medical Track. She is pursuing a degree in Microbiology with a minor in Business at the University of Michigan. She is passionate about learning how healthcare and business intersect, and Blueprints provides her the perfect opportunity to delve deeper into both areas. Shreya hopes to attend medical school and become a physician that works to eliminate health inequities through setting up a free clinic.

Healthcare Startups for Cancer
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AI Talos is a Canada-based startup providing “AI-guided decision-making support for breast cancer screening.” The company features tools and support for both patients and healthcare workers. The Talos App allows individuals to upload images taken by a compact thermal camera, and receive a risk assessment and recommended next steps such as whether to visit a physician. Talos Cloud enables thermographers to work alongside accurate, interpretable AI software to help direct and confirm diagnoses. 

Zealth is another cancer-focused growing startup, focused on normalizing care and therapy for patients. Zealth aims to fill the gap between patient’s unanswered concerns, and doctors’ missing 360 view of their patient’s wellbeing. The company’s AI platform CareShare remotely connects patients to doctors and provides real-time health monitoring, empowering patients with timely information and reducing burden from their doctors. The platform additionally offers tools to manage personalized medication and nutrition, and provides support for patients to understand their test reports. 

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