The heads of the newly formed private-public partnership comprising industry, academia and FDA describe the group’s top three projects to advance medical device regulatory science.
Noted physician/entrepreneur John Simpson is back. His latest company, Avinger, has finally achieved his long-sought goal: combining imaging and therapeutics in catheter technology for crossing CTOs. Will clinical innovation be enough to reward Avinger in an increasingly economically focused medtech world?
On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue.
CMS held its annual new-technology Town Hall February 5, hearing from applicants for a drug-eluting peripheral artery stent, a neurostimulator system for epilepsy seizures, a transcatheter mitral valve repair system and a retinal prosthesis system.
Recent visits to Brazil by three medical device trade groups are telling of the opportunities there for U.S. device companies, in spite of barriers related to regulation, reimbursement and compliance.
In late December 2012, Covidien announced a definitive agreement to acquire drug-coated balloon company CV Ingenuity for an undisclosed amount. Covidien joins large cardiovascular device players such as Medtronic, which gained a drug-coated balloon when it acquired Invatec in 2010, and CR Bard, which has the lead in the US market as a result of its acquisition last year of Lutonix Inc. as well as a large number of DCB companies based in Europe.
In late December 2012, Covidien announced a definitive agreement to acquire drug-coated balloon company CV Ingenuity for an undisclosed amount. Covidien joins large cardiovascular device players such as Medtronic, which gained a drug-coated balloon when it acquired Invatec in 2010, and CR Bard, which has the lead in the US market as a result of its acquisition last year of Lutonix Inc. as well as a large number of DCB companies based in Europe.
Device manufacturers are developing several next-generation devices for the minimally invasive treatment of obesity. Many of these emerging devices not only mimic the restriction and malabsorption mechanisms involved in bariatric surgery, but are also designed to influence the metabolic responses that are key to losing weight, improving outcomes, and impacting chronic disease.
A profound redefinition of the role of many cell types and biomaterials in regenerative medicine is under way as researchers have moved away from the notion that cells introduced into the body will integrate and become functioning tissue.
