As predicted, the next incremental advances in the growing A-fib heart space may very well be in contact force catheter technology. St. Jude’s Medical is banking on it. The company just acquired Endosense, a Switzerland company that creates contact force ablation catheter technology, for $170 million. If Endosense meets an undisclosed regulatory milestone, it could […]
While Europe may still provide a faster route to regulatory approval for such devices, post-market requirements are creeping in like an expensive final cheese course served by European regulators and health systems just when companies are feeling most broke and tired. So regulatory approvals may come, but actual, meaningful revenues? Not so fast.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Looking for a way to send ObamaCare foes into a tizzy? Try suggesting emulating the French system. In any way. Yet if we believe in learning from best practices, we should start doing what the French are doing for people with Alzheimer's and their families.
Different experiences have already driven the development, introduction and market withdrawals of obesity treatment products in the USA versus Europe. And as the obesity problem gets worse, these differences will steadily shift in different directions.
ALung Technologies Inc. has raised a $10 million series B round in preparation for a product launch of its Hemolung oxygen-delivery device in Germany this year, the Pittsburgh Tribune-Review is reporting. MedCity News reported back in December that the medical device company had already raised $6.6 million and filed for the CE Mark. The Hemolung […]
The regulatory process for reviewing medical devices in Europe is coming under fire after a controversy over leaking breast implants made in France. That’s a big deal for U.S. medical device companies, who frequently praise the European regulatory system as faster, less burdensome and more supportive of technological innovation. Many in the device industry would […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.