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1/27/2020

A team of researchers at the Korea Institute of Medical Microrobotics has created a magnetic microbot that can treat damaged cartilage in the knee by delivering stem cells to the injured site. The team is working toward approval to conduct human trials of the device.

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Cosmos Online
1/27/2020

Singapore-based Veredus Laboratories said is developing a test called VereCoV for the detection, differentiation and identification of the Wuhan, SARS and MERS coronaviruses. The detection kit, a portable lab-on-chip device that can provide results in around two hours, is expected to become available in the markets by Feb. 1.

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Veredus Laboratories
1/27/2020

The European Commission's Medical Device Coordination Group is expected to hold 14 meetings between now and the May implementation of Medical Devices Regulation. The meetings will cover clinical studies, periodic safety update reports, unique device identification and in vitro diagnostics, among other topics.

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Regulatory Focus
1/27/2020

The FDA has granted Abbott Laboratories an expanded indication for its Infinity directional deep brain stimulation system to treat symptoms of Parkinson's disease. The company also reported positive data from two studies of its Proclaim XR neuromodulation system in people with chronic pain.

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XR
1/27/2020

China's National Medical Products Administration has approved four products for coronavirus detection, including reagent test kits and sequencing system. The agency also said it would continue using special approval procedures for medical devices and drugs designed to combat the disease.

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NewKerala (India)
1/27/2020

The FDA has issued a final guidance on the use of minimal residual disease as a biomarker in clinical tests for certain hematologic malignancies. "Depending upon the clinical setting, MRD may be used to reflect a patient's response to treatment or as a prognostic tool to assess a patient's risk of future relapse," according to the guidance.

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Regulatory Focus
1/27/2020

A group of senators is calling on the FDA to issue rules that would prevent labeling of plant-based products as cheese, milk or yogurt to "ensure that dairy terms may only be used to describe products that include dairy." In a letter sent to FDA Commissioner Stephen Hahn, the senators said the labeling issue is "both unfair to our hardworking dairy farmers and problematic for consumers, making it harder for Americans to make educated decisions."

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The Hill
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Commissioner Stephen Hahn
1/27/2020

A bill that would raise the minimum age for buying tobacco products, including e-cigarettes, from 18 to 21 has been passed by the Kentucky Senate. The legislation now goes to the state House for consideration.

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Public News Service
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Senate
1/27/2020

The National Institute for Health and Care Excellence raised questions about Novo Nordisk's obesity drug Saxenda and did not approve it for England's NHS. The regulator questioned data that states the drug reduces cardiovascular risks and its price.

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FiercePharma
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Saxenda
1/27/2020

The conscientious implementation of clinical biosafety and infection control practices help health care staff remain disease-free while treating people with either Lassa fever or the Ebola virus, according to a study based on observations made at Emory University Hospital's Serious Communicable Diseases Unit. The results were reported in the journal Infection Control & Hospital Epidemiology.