CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work

“Why are insurers so reluctant to get enthusiastic and really embrace molecular diagnostics?” asked the director of CMS’ coverage and analysis group at a recent cancer diagnostics symposium. “Because half the time we have no idea what on earth we’re paying for.”

CMS Coverage and Analysis Group director Louis Jacques tried to temper the widespread enthusiasm for scientific advances in cancer diagnosis in his concluding speech at an Oct. 29 Washington, D.C. symposium on cancer diagnostics and personalized medicine.

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Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
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The architect of Germany’s hospital reform, Karl Lauterbach, has not been retained in the new CDU/CSU-SPD coalition government, which has put forward Tino Sorge for health minister.

Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

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CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Commission Needs To Prioritize Devices Agency Above All Else

 

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Shuren Expects Longer CDRH Review Times

 
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The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.