Insulet Wins FDA Clearance For Omnipod ACE Pump

Diabetes company Insulet received US FDA clearance to market its Omnipod DASH alternate controller-enabled infusion pump as an integrated insulin pump.

Diabetes

Diabetes company Insulet Corp. announced today it received US Food and Drug Administration clearance for its alternate controller-enabled infusion pump (ACE Pump), which allows the firm to market its Omnipod DASH insulin management system as an integrated insulin pump. 

The Acton, MA-based company received 510(k) clearance from the FDA last June for the Omnipod DASH, a wireless system that...

Welcome to Medtech Insight

Create an account to read this article

More from Diabetic Care

US CMS Sets Out Competitive Bidding Rental Model for CGMs; Abbott, Dexcom Could Face Impact

 
• By 

CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

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

 
• By 

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.

ADA 2025: Tandem Becomes Abbott’s Fourth Partner In Push To Advance Dual Sensor CGM Strategy

 
• By 

Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.

More from Device Area

Endo Tools, Fujifilm Partner to Fast-Track Endomina Rollout Across MEA Region

 
• By 

CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By 

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.