Two novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week. Among them, Tandem Diabetes Care Inc. netted a first with US FDA. On Feb. 14, the agency granted a de novo classification to a version of Tandem's t:Slim X2 insulin pump with technology allowing it to be used with a variety of different components that make up diabetes therapy systems.
Global Device Approvals, Weekly Snapshot: Tandem Diabetes Win
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

More from Approvals
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.
Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.
The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.
More from Policy & Regulation
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.