FDA clearance

Jan 04, 2017

With FDA Clearance, Nanowear Looks to Commercialize Cardiac Dx Wearables

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The firm said that the push toward outcomes-based medicine will drive innovation in diagnostic wearables and smart textiles over the next few years.

Dec 21, 2016

Your Phone Can Diagnose What's Wrong With You. But Should You Trust It?

Mobile apps could one day transform the way diseases are diagnosed, but concerns have been raised about their accuracy and safety.

Dec 20, 2016

InBios Receives FDA Clearance for Rapid POC Chagas Test

The firm said that it is the first point-of-care diagnostic test available in the US to detect a potentially fatal disease that affects around 8 million people globally.

Dec 20, 2016

Instrumentation Laboratory Gets FDA Clearance for Dx Analyzer, Sample Quality Manager

The firm said that its analyzer and intelligent quality management system enhance the efficiency of testing and reduce the total cost of care.

Dec 19, 2016

Cepheid Receives FDA Clearance for MRSA MDx

To develop the test, the firm said it used a library of MRSA strains collected around the world, and included components that reduce false positive results.

Oct 26, 2016

Quidel Q3 Revenues Up 5 Percent on Women's Health, MDx Sales

The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.

Oct 25, 2016

Agilent Receives Expanded FDA Approval for Keytruda Companion Dx

The FDA has approved Merck's Keytruda as a first-line treatment for non-small cell lung cancer in patients with high PD-L1 expression.

Oct 21, 2016

Roche Receives FDA Approval for Cobas MPX Test

The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.

Aug 03, 2016

Bio-Rad Quality Control Products Receive FDA Clearance

The firm's multi-analyte quality controls for nucleic acid tests are designed to help large and small labs mitigate quality challenges.

Aug 03, 2016

Luminex Receives FDA Clearance for Influenza A/B, Respiratory Syncytial Virus Assays

The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.

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FDA clearance

With FDA Clearance, Nanowear Looks to Commercialize Cardiac Dx Wearables

Your Phone Can Diagnose What's Wrong With You. But Should You Trust It?

InBios Receives FDA Clearance for Rapid POC Chagas Test

Instrumentation Laboratory Gets FDA Clearance for Dx Analyzer, Sample Quality Manager

Cepheid Receives FDA Clearance for MRSA MDx

Quidel Q3 Revenues Up 5 Percent on Women's Health, MDx Sales

Agilent Receives Expanded FDA Approval for Keytruda Companion Dx

Roche Receives FDA Approval for Cobas MPX Test

Bio-Rad Quality Control Products Receive FDA Clearance

Luminex Receives FDA Clearance for Influenza A/B, Respiratory Syncytial Virus Assays

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