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New Product Briefs: ReSure Sealant, Direct Flow TAVR; DePuy Spine Device

Ocular Therapeutix’s ReSure Sealant gains PMA approval for sealing cataract surgery incisions. Direct Flow gains CE mark for larger version of its repositionable transcatheter aortic valve replacement. More product news.

FDA announced PMA approval of Ocular Therapeutix Inc.’s ReSure Sealant Jan. 9. The gel sealant is the first approved alternative to stitches for closing a leaking corneal incision after cataract surgery with intraocular lens placement in adults. Ocular’s product stops fluid from leaking through the incision by adhering to the eye soon after application and sealing the incision. The gel gradually breaks down over the course of seven days and is cleared from the body by the eye’s natural tears.

An FDA panel provided general support for Ocular’s submission, based primarily on a 471-patient pivotal study, during a meeting last September, though there were questions as to whether the company’s...

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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.