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FDA News

 

Cardiology Month in Review: September 2022

September 24, 2022

The final weekend of each month, our editorial staff compiles a list of our most popular content from the past month. The top content from September 2022 includes trio of FDA approvals, a TCT headliner, a look back at ESC Congress 22, and a new prognostic biomarker for heart failure.

LINQ II ICM Receives Historic FDA Clearance for Children Aged 2 Years and Older

September 20, 2022

Announced on September 20, the FDA's latest 510(k) clearance for the LINQ II ICM, which received clearance in adult populations in 2020, means the LINQ II ICM is the first and only insertable cardiac monitor approved for pediatric populations aged 2 years and older.

FDA Approves PASCAL Precision System for TEER in Degenerative Mitral Regurgitation

September 16, 2022

Announced on September 15 by Edwards Lifesciences Corporation, the PASCAL Precision transcatheter valve repair system has received approval for transcatheter edge-to-edge repair in patients with degenerative mitral regurgitation.

FDA Expands WATCHMAN FLX Approval to Include DAPT Option

September 06, 2022

Announced by Boston Scientific on September 6, the label for the WATCHMAN FLX LAAC device now includes a 45-day DAPT option as an alternative to the 45-day postprocedural OAC plus aspirin regimen for patients with nonvalvular atrial fibrillation.

Cardiometabolic Decisions and Trials to Watch for Second Half of 2022

July 08, 2022

After highlighting the first half of the year in our top decisions from the first half of 2022, Practical Cardiology’s editorial staff fixed its gaze on the cardiology pipeline for the remainder of 2022. In this list, we highlight potential FDA Decisions and trials to watch for in the second half of the year.

Top FDA Decisions in Cardiometabolic Health from the First Half of 2022

July 01, 2022

The first half of 2022 has seen its fair share of FDA decisions, both approvals and CRLs. In this article, we recap the top regulatory events in cardiorenal metabolic health from the first half of the year, including news related to empagliflozin, mavacamten, and more.

Understanding the Mavacamten Approval: Perspective from an oHCM Specialist

April 29, 2022

Martin Maron, MD, medical director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center, participates in a Q&A related to the approval of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy.

FDA Issues CRL for Vadadustat in Treatment of Anemia Due to CKD

March 30, 2022

On March 30, Akieba Therapeutics announced the receipt of a CRL from the FDA for their NDA for vadadustat as a treatment for anemia due to chronic kidney dialysis in adult patients on dialysis and not on dialysis.