FDA Clears Medtronic's And Boston Scientific's Remote Cardiac Monitors, Approves Abbott’s Bluetooth-Compatible ICDs

Medtronic will launch the LINQ II remotely programmable, insertable cardiac monitor in the US and Europe this summer following FDA clearance. Boston Scientific plans to launch its LUX-Dx monitor later this year. The agency also approved Abbott's Gallant ICD and CRT-D devices, which communicate with Abbott's myMerlinPulse mobile app.

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More from Approvals

First At-Home Test For Multiple STIs Gets FDA Clearance

 
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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.

Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 

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.

Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain

 
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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.

Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years

 
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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

Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

Global Medtech Guidance Tracker: March 2025

 
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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.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.