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Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

 
• By Catherine Longworth

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

Duodenoscopes are used in more than half a million endoscopic retrograde cholangiopancreatography (ERCP) procedures annually, but the prevention of cross-contamination in these medical devices continues to be a major challenge in clinical practice.

Due to the complex design of duodenoscopes, they require thorough processes to properly clean and disinfect, which if not performed...

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EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
• By Amanda Maxwell

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
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US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

More from Policy & Regulation

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
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US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
• By Eileen Francis

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.