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4C Medical Plans First Early Feasibility Study For An Implantable In Japan

 
• By Elizabeth Orr

4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.

American and Japanese Flags waving against blue Sky
• Source: Shutterstock

Start-up mitral valve regurgitation treatment firm 4C Medical Technologies is preparing for the first early feasibility study of an implantable device to be conducted in Japan, company President and CEO Bob Thatcher said March 5 at the Cardiovascular Research Technologies (CRT) annual conference in Washington, DC.

A long-running collaboration between US FDA and the Japanese Pharmaceutical and Medical Device Agency (PMDA) known as Harmonization by...

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Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 
• By Natasha Barrow

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.