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BioWorld - Sunday, December 14, 2025
Home » Topics » Regulatory

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EU greenlights Abbott’s transcatheter mitral valve replacement device

Jan. 30, 2020
By Meg Bryant
Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.
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Regulatory front for Jan. 30, 2020

Jan. 30, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Jan. 30, 2020

Jan. 30, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Erleada receives extended approval in Europe for metastatic hormone-sensitive prostate cancer

Jan. 30, 2020

Regulatory front for Jan. 29, 2020

Jan. 29, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Map of South America

Med-tech sector crashes in Venezuela

Jan. 29, 2020
By Sergio Held
BOGOTA, Colombia – Venezuela’s med-tech sector has been virtually decimated by the ongoing crisis, which has not only displaced millions of people but also destroyed the country’s economy over the past four years.
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Verily gets second Study Watch FDA clearance as it digs into Irhythm AF collaboration

Jan. 29, 2020
By Stacy Lawrence
Diabetes is the first med-tech sphere that is coalescing for Verily Life Sciences LLC, but cardiology could be next. The South San Francisco-based business that’s part of Google parent Alphabet Inc. has received a second FDA clearance for its Verily Study Watch as an irregular pulse monitor. After a 2017 debut, it was first cleared by the agency about a year ago for use to take an on-demand electrocardiogram (ECG).
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Regulatory front for Jan. 29, 2020

Jan. 29, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Architectural pillars

Regulatory front for Jan. 28, 2020

Jan. 28, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Innate Immunotherapeutics, Australia’s Therapeutic Goods Administration
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Blocks with upward arrows

Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 28, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.
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