FDA News

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.

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.

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.

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.

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.

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.

May 13, 2022

Announced on May 13, the Onyx Frontier DES carries the same clinical indications as Medtronic's Resolute Onyx DES and will be available in 2.0 mm sizes as well as 4.50-5.00 mm sizes that can be expanded to 6.00 mm.

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.

April 29, 2022

Bristol Myers Squibb announced the FDA's approval of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy in a press release on April 28.

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.