If At First You Don’t Succeed: VALID Act For Diagnostics Introduced In Congress For Third Time

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which calls for a new regulatory framework for diagnostic tests, has been reintroduced in the US Congress.

US Capitol.

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

 

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

 

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.