FDA clears expanded labeling for Preceptis Medical’s ear tube system

Preceptis Medical announced earlier this week that the FDA cleared expanded indications for its Hummingbird tympanostomy tube system (TTS).

New labeling for the Hummingbird system for office-based pediatric ear tube procedures allows for in-office procedures in all children six months and older.

Previous FDA clearance allowed for the use in children between six months old and 24 months old, Maple Grove, Minnesota-based Preceptis said in a news release. The FDA originally cleared the system in 2020.

The company designed the Hummingbird TTS to combine the separate tools and steps performed in standard ear tube procedures into one comprehensive device. It allows otolaryngologists, or ear, nose and throat specialists (ENTs) to make an incision and deliver an ear tube using a single pass in the office environment.

Preceptis said the device eliminates the need for fasting, general anesthesia, and an operating room and has demonstrated 98% success in the…

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The top 10 catheter innovations of 2021

Photo by Kelly Sikkema on Unsplash

Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes.

Catheter innovations weren’t limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released.

And catheter-based devices made up nearly half of last year’s Prix Galien USA Awards nominees for the most innovative medical devices. Those devices included BD’s PureWick female external catheter and Venovo venous stent, Biotronik’s PK Papyrus covered coronary stent system, Boston Scientific’s HeartLogic heart failure monitoring device and Sentinel cerebral protection system, Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve, Pulmonx’s Zephyr end-bronchial valve system and Baylis Medical’s VersaCross transeptal platform. (VersaCross, Venovo, PureWick and Sapien 3 Ultra are eligible for resubmission fo…

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FDA clears Preceptis Medical’s in-office ear tube placement for kids

Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office.

Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t need to be in an operating room.

“Our office clinical study in over 200 children 6- to 24-months-old showed a 99% success rate in the office and a total procedure time of 5 minutes. This clearance will allow parents an option to have their child’s ear tubes placed without the need for general anesthesia or an operating room, while significantly reducing their costs,” Preceptis Medical CEO Steve Anderson said in a LinkedIn post.

Anderson in a company news release described the 510(k) clearance as an important milestone.

Dr. Shelagh Cofer,…

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