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ReShape Dual Balloon Enters U.S. Market, Headlining Week Of Obesity Device News

 
• By David Filmore

It was a banner day for minimally invasive weight-loss devices July 28. FDA approved ReShape Medical's intragastric balloon and Aspire Bariatrics submitted an application for its AspireAssist aspiration therapy system for obesity. Two days later, GI Dynamics announced the termination of a pivotal study for its Endobarrier device.

FDA OK'd its second obesity device this year on July 28, with the PMA approval for ReShape Medical Inc.'s ReShape weight-loss system. On the same day, Aspire Bariatrics Inc. announced a PMA submission for its AspireAssist aspiration therapy weight-loss device, reflecting the increasingly active field of prospective device competitors in the obesity space.

ReShape's integrated dual intragastric balloon system, which previously obtained the European CE mark, is designed to occupy space in the...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.