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Life Sciences
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4/15/2021

A panel of CDC advisers decided to postpone a vote on whether the US government should call for states to resume the use of Johnson & Johnson's single-dose COVID-19 vaccine, in order to gather more safety information. The vote could be delayed by at least a week as the panel investigates six rare blood clot incidents linked to the vaccine.

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Reuters
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US government
4/15/2021

AstraZeneca and Sanguina are working together to develop a customized version of the latter's AnemoCheck Mobile app that would allow for bloodless blood testing of patients with anemia by analyzing photos of their nailbeds to measure hemoglobin levels.

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FierceBiotech
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Sanguina
4/15/2021

Marc Mackey has been chosen to serve as executive vice president of digital surgery at Surgalign. Mackey will also assume leadership of the company's digital surgery team, which was formed following the acquisition of Holo Surgical in September 2020.

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Becker's Spine Review
4/15/2021

The Medtronic Extended infusion set for diabetes has been released in select European countries. "The Medtronic Extended infusion set introduces increased simplicity and convenience -- something we're looking to deliver across all of our products and services to help ease burden and enhance the experience for people wherever they are in their diabetes journey," said Julie Foster, Medtronic diabetes business VP of customer experience.

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Medtronic diabetes
4/15/2021

An underwritten public offering of 2.9 million shares of common stock has brought in $149.7 million for Outset Medical.

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MassDevice (Boston)
4/15/2021

New Mexico-based RingIR is developing a breath-based technology that can detect COVID-19 within seconds.

4/15/2021

The FDA has given 510(k) clearance to Becton Dickinson for its Pristine Long-Term Hemodialysis Catheter.

4/15/2021

European regulators have given CE mark approval to OncoSec Medical for its GenPulse, a part of the company's electroporation device platform that is used to treat solid tumors.

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MassDevice (Boston)
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tumors
4/15/2021

European regulators have given CE mark approval to Hemanext's Hemanext ONE Red Blood Cell processing and storage system, which limits carbon dioxide and oxygen levels in stored RBCs.

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FDAnews
4/15/2021

The FDA has released a guidance explaining how the agency plans to conduct remote interactive evaluations of pharmaceutical and biomedical research sites during the pandemic. The agency said it will consider the use of remote interactive evaluations for all of its drug inspection programs, and some of the tools that will be used during remote inspections include livestreaming video, teleconferencing and screen-sharing technologies.

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Regulatory Focus