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FDA Clears Another Zika Assay, Luminex's xMap

 
• By Elizabeth Orr

The xMap Multiflex Zika RNA Assay is a molecular diagnostic that is designed to detect the Zika virus in human serum, urine or plasma.

The US FDA announced the clearance of another Zika assay Aug. 4, Luminex Corp.’s xMap Multiflex Zika RNA Assay.

The test carries an indication for use of detecting the Zika virus in human serum, plasma and urine. The assay...

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Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 
• By Brian Bossetta

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
• By Brian Bossetta

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

More from North America

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 
• By Brian Bossetta

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 
• By Amanda Maxwell

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.