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FDA Approves Abbott Xience DES For Short Dual-Antiplatelet Course

 
• By Reed Miller

The agency approved the Xience stents as suitable for patients at high bleeding-risk who can only stay on antiplatelet therapy for four weeks. Abbott also announced that it has received FDA approval and European CE mark approval for its Xience Skypoint stent.

Abbott's Xience Skypoint Everolimus-Eluting Stent
Abbott's Xience Skypoint Everolimus-Eluting Stent • Source: Abbott

Abbott’s Xience everolimus-eluting stent has joined the group of drug-eluting coronary stents approved by the US Food and Drug Administration for patients at high risk of bleeding.

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More from Approvals

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By Elizabeth Orr

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.

More from Policy & Regulation

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.