Edwards, Abbott Settle Mitral Repair Patent Cases

Edwards Lifesciences is paying Abbott Laboratories to settle disputes over patents on transcatheter mitral and tricuspid repair products.

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More from Legal & IP

US Federal Trade Commission Challenges Surmodics-Biocoat Merger Over Antitrust Concerns

 
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A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.

Court Decision On LDTs ‘Quite Realistic’ Before May Deadline, Says ACLA Attorney

 

An attorney representing the ACLA in its lawsuit to stop the US FDA’s final rule on LDTs emerged from a lengthy hearing on the case feeling ‘cautiously optimistic’ and said a decision could come before May.

Non-EU Medtech Firms May Face Suits Under New Product Liability Directive

 

The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.

Court to Decide on Rehearing for Doctor Convicted of Reusing Sinus Balloons

 
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Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.

More from Policy & Regulation

New FDA Commissioner Makary Could Face Turbulent Waters

 

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.