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Acclarent Expects TruDi Shaver Blade To Prevent Repeat ENT Surgeries

 
• By Reed Miller

The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.

sinus inspection shutterstock
• Source: Shutterstock

Acclarent, a Johnson & Johnson subsidiary, is applying precision sensor technology to ear, nose and throat (ENT) surgery to improve outcomes and reduce the need for repeat procedures.

The US Food and Drug Administration recently cleared Acclarent’s TruDi electromagnetically navigated shaver blade to be used with

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More from Surgery

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

More from Device Area

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.