Today the fight for the continuous glucose monitoring market isn’t so much about a large company and a mid-sized one battling for market share as about acceptance of the entire category of CGM, which remains low after more than a decade. DexCom believes that CGM should be a first-line blood glucose management tool to help diabetes patients keep their blood glucose levels within a healthy range, and now with the launch of a stellar fourth-generation product, the company is closer than ever to realizing that goal.
Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.
Controversy continues to swirl around robotic surgical procedures and this time the target is robotic hysterectomy. However, the drama does not seem to be impacting the number of these procedures performed robotically, a statistic that is clearly on the rise.
Derived from Strategic Transactions, Elsevier Business Intelligence’s premium source for tracking life sciences deal activity, the Recent Financings Of Private Companies column provides a comprehensive monthly review of emerging life science companies that have received venture funding, including companies within the In Vitro Diagnostics, Medical Devices, and Pharmaceuticals sectors.
CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.
The PREVAIL study of Boston Scientific’s Watchman left atrial appendage (LAA) closure device was primarily positive, but will it be enough to win FDA approval for the device?
Neuros Medical Inc.’s Altius is an implantable device that transmits a high-frequency electrical signal to a targeted nerve in the stump of a patient experiencing chronic pain stemming from a major limb amputation. Blocking the nerve activity eliminates the pain.
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?
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.
