Adhesys Medical, a surgical adhesive company, said it has received a CE mark for its Mar-Cutis Flix topical skin adhesive for surgical use.
The 510(k) nod positions Surmodics to start shipping a device designed for use in the treatment of complex coronary and peripheral lesions.
Surgeons can now use the flexible scope to visualize and access sites in procedures that start with incisions to the abdomen or thoracic cavity.
The clearance follows almost 20 years of work by the car manufacturer to get the exoskeleton-style device ready for widespread use.
The FDA has committed to making the U.S. market a top priority for more than 50% of developers of novel devices by the end of 2020.
In a recent report, the Government Accountability Office said the FDA should release plans to issue or revise guidance for complex generic drugs.
Senators Elizabeth Warren and Ed Markey, both Democrats from Massachusetts, unveiled legislation that would eliminate excise tax on medical devices.
Medtronic was one of a clutch of companies told to apologize for listing a region China sees as part of its territory as an independent country.
Official statistics show a 59% year-on-year drop in foreign direct investment over the first nine months of 2017.
The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids.