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FDA News
FDA Approves Medtronic Cardiac Lead for Conduction System Pacing
October 17, 2022
Announced on October 17, the US FDA's expanded indication for Medtronic's SelectSecure™ MRI SureScan Model 3830 cardiac lead makes it the first and only device with FDA approval for conduction system pacing, according to a release from Medtronic.
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.
Onyx Frontier Drug-Eluting Stent Receives FDA Approval for CAD
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.
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 Approves Mavacamten (Camzyos) for 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.