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BioWorld - Wednesday, April 8, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
Regulatory, Medical technology RSS Feed RSS

FDA retains 'well-defined' restriction in special 510(k) final

Sep. 13, 2019
By Mark McCarty

Health of U.S. patent system in the eye of the beholder

Sep. 13, 2019
By Mari Serebrov
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
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Product regulatory actions for Sept. 12, 2019

Sep. 13, 2019

Product regulatory actions for Sept. 11, 2019

Sep. 12, 2019

Budget restrictions on the way for medical devices in France

Sep. 11, 2019
By Bernard Banga

Regulatory front

Sep. 11, 2019

Product regulatory actions for Sept. 10, 2019

Sep. 11, 2019

Regulatory front

Sep. 10, 2019

Product regulatory actions for Sept. 9, 2019

Sep. 10, 2019

Sonivie's PAH treatment scores FDA breakthrough device designation

Sep. 10, 2019
By Meg Bryant
The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.
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