Meeting March 19-21 in France, the International Medical Device Regulators Forum announced a major new project on standalone device software and the upcoming release of several guidance documents for public comment.
Clinicians who work with stroke patients are beginning to look at robotics and other innovative technologies in rehabilitation that could allow for more treatments without increasing staffing. Young companies with products in development compete with established players in this market, which eventually could become more important to providers as reform efforts move ahead.
TearScience Inc. isready to go into full-scale commercialization for a new device treatment for the most prevalent form of dry eye. In late February, the young company secured up to $70 million from HealthCare Royalty Partners to help make that happen.
Long used to a growing market driven by favorable demographics, cardiovascular companies are facing a declining PCI market, in the US and Europe at least, and are forced to shift their strategies to adapt. Volcano, for one, is articulating a new way to approach this declining market.
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.
CardioKinetix, maker of a unique, percutaneously placed ventricular partitioning device, and CircuLite, which is developing a less invasive cardiac assist device, are moving into US clinical trials with their technologies – an important milestone for emerging companies in the difficult heart failure space. Both offer therapies aimed at helping fill the huge heart failure treatment gap that exists today.
The meniscal suture passer from Ceterix Orthopaedics Inc. is a handheld surgical instrument that due to its small size and design facilitates meniscus repair. Because it leaves the cushion of the meniscus intact, the company believes its device will help patients avoid the arthritic changes that frequently accompany meniscus removal.
The March 26 special fraud alert reiterates the HHS watchdog’s “longstanding position that the opportunity for a referring physician to earn a profit, including through an investment in an entity for which he or she generates business, could constitute illegal remuneration under the anti-kickback statute.”
While launching a new balloon-based device to treat chronic sinusitis, Entellus Medical Inc. revealed it would release details on an important clinical study in July.
