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BioWorld - Tuesday, March 3, 2026
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Regulatory front for Nov. 13, 2019

Nov. 13, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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hologic-3Dquorum-11-13.png

Following solid quarterly results, Hologic gains FDA nod for 3Dquorum imaging tech

Nov. 13, 2019
By Liz Hollis
Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said.
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DNA

FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
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Regulatory front for Nov. 13, 2019

Nov. 13, 2019
The latest global regulatory news, changes and updates affecting biopharma.
Read More

FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
Read More

European Commission grants conditional marketing authorization to Ebola Zaire vaccine Ervebo

Nov. 12, 2019

Regulatory front for Nov. 12, 2019

Nov. 12, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Nov. 12, 2019

Nov. 12, 2019
The latest global regulatory news, changes and updates affecting biopharma.
Read More

FDA approves Reblozyl for anemia in beta thalassemia requiring regular RBC transfusions

Nov. 11, 2019

Regulatory front for Nov. 11, 2019

Nov. 11, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
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