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12/3/2021

The FDA has given clearance to Canon Medical Systems for its Vantage Fortian MRI scanner. The system features an accompanying tablet-based Tablet UX software that can help technologists position patients and an overhead camera that can be placed in the MRI suite.

12/3/2021

The FDA has given 510(k) clearance to CoreLink for its CentraFix midline fixation system, a posterior thoracolumbar pedicle screw for less invasive spinal fixation. The company has also commercially launched the device.

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MassDevice (Boston)
12/3/2021

The FDA has given 510(k) clearance to Acurable for its AcuPebble SA100, a wearable sleep apnea home testing device.

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FDAnews
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sleep apnea
12/3/2021

European regulators have given CE mark certification to Rhythm Biosciences for its ColoSTAT blood test, which detects colorectal cancer by measuring the presence of multiple protein biomarkers that have been identified by Australia's Commonwealth Scientific and Industrial Research Organization.

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FDAnews
12/3/2021

European regulators have given CE mark certification to DNA Script for its Syntax DNA printer.

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FDAnews
12/3/2021

Alnylam Pharmaceuticals Chief Operating Officer Yvonne Greenstreet's daughter, Emma, encouraged her mother to accept the job of Alnylam CEO, "because you have no idea what it's going to mean to young women like myself to see you in the position." Greenstreet's 88-year-old mother, who set up an adult literacy institute in her native Ghana, had a similar reaction, and when Greenstreet steps up to the role in January, she will be only the sixth woman to head a biopharmaceutical company with a market value of $5 billion or more.

12/3/2021

Biotech startup HotSpot Therapeutics raised $100 million in a Series C round, bringing the company's total to $190 million. Former Nimbus executives Jonathan Montagu and Gerry Harriman co-founded HotSpot four years ago, building a portfolio of therapies targeting natural hotspots on proteins identified using the company's artificial intelligence platform.

12/3/2021

The percentage of working scientists who think their employer's diversity and inclusion efforts are sufficient fell from 51% in 2018 to 40% in Nature's salary and job satisfaction survey this year, and the percentage who had witnessed harassment or discrimination rose from 28% to 32%. Free-form comments reflected a variety of perceptions and opinions on discrimination, diversity and the need for D&I initiatives.

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Nature
12/3/2021

The UK has ordered additional COVID-19 vaccines from Pfizer/BioNTech and Moderna in preparation for the imminent health threat from the new Omicron coronavirus variant. Two new contracts were signed: one for an additional 54 million Pfizer/BioNTech vaccine doses and another for 60 million doses from Moderna.

12/3/2021

Novartis has partnered with UCB of Belgium in a deal potentially worth $1.5 billion that will focus on co-development and commercialization of two treatments, UCB0599 and UCB7853, which target Parkinson's disease. UCB will receive an upfront payment of $150 million as part of the deal and potential milestone payments worth nearly $1.5 billion.

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UCB