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BioWorld - Tuesday, December 10, 2019
Home » Topics » Regulatory

Regulatory
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Aussie device makers urge TGA to follow IMDRF lead on software regulations

November 13, 2019
By Mark McCarty
No Comments
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
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Regulatory front for Nov. 13, 2019

November 13, 2019
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Following solid quarterly results, Hologic gains FDA nod for 3Dquorum imaging tech

November 13, 2019
By Liz Hollis
No Comments
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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FDA clears first whole exome sequencing platform for overall tumor mutation burden

November 13, 2019
By Meg Bryant
No Comments
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

November 13, 2019
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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FDA clears first whole exome sequencing platform for overall tumor mutation burden

November 13, 2019
By Meg Bryant
No Comments
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

Regulatory front for Nov. 12, 2019

November 12, 2019
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Nov. 12, 2019

November 12, 2019
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Nov. 11, 2019

November 11, 2019
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Latest telehealth bill would dismantle some geographic restrictions

November 11, 2019
By Mark McCarty
No Comments
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
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