Latest medtech regulatory news

Watchman FLX LAAC device gains additional FDA approval

Boston Scientific Corp. received U.S. Food and Drug Administration approval to expand the instructions for use labeling for the current-generation Watchman FLX Left Atrial Appendage Closure (LAAC) device. Instructions for use labeling will include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation (NVAF).

Expanded labeling for hummingbird system

Preceptis Medical Inc., a surgical technology company dedicated to providing less invasive options for pediatric patients, received U.S. FDA clearance for expanded indications for use for the Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures for children six months and older.

The Hummingbird TTS combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, otolaryngologists or ear, nose, and throat specialists (ENTs) make an incision and deliver an ear tube using a single pass in the office environment. The device eliminates the need for fasting, general anesthesia, and an operating room – all with 98% success in the office setting. The procedure requires only a topical anesthetic, and parents can be present with their child to provide further comfort.