Debate spotlights policy divisions over health care | Federal judge approves broad framework for settling opioids lawsuits | FDA approval granted to tenapanor for adult IBS with constipation
September 13, 2019
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Debate spotlights policy divisions over health care
Debate spotlights policy divisions over health care
(Robyn Beck/AFP/Getty Images)
Health care again took center stage in Thursday's night Democratic debate, with former Vice President Joe Biden attacking Sens. Bernie Sanders, I-Vt., and Elizabeth Warren, D-Mass., over the cost of their Medicare for All proposal. Eight of the presidential hopefuls in Thursday's debate support a public option or some sort other policy framework that would maintain a substantial role for private health insurance.
National Public Radio (9/13) 
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Federal judge approves broad framework for settling opioids lawsuits
A federal judge approved a plan to include every state and municipality in the US in settlement talks with makers of opioid drugs, though he said states may settle cases however they choose.
Reuters (9/11) 
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FDA approval granted to tenapanor for adult IBS with constipation
FDA approval granted to tenapanor for adult IBS with constipation
(Pixabay)
The FDA has approved Ardelyx's Ibsrela, or tenapanor, to treat adult irritable bowel syndrome with constipation, to be taken twice daily in 50-mg doses. Patients who have or are suspected of having mechanical gastrointestinal obstruction are not advised to take Ibsrela.
Medscape (free registration) (9/12) 
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Medical Devices
Bio-Rad files lawsuit against 10x Genomics for patent infringement
Bio-Rad Laboratories is suing 10x Genomics, alleging infringement of a patent covering techniques for detecting enzymatic reactions in microfluidic droplets. The company seeks damages, attorney fees and costs and an injunction or ongoing royalty.
GenomeWeb Daily News (free registration) (9/12) 
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EU OKs LumaCyte's Radiance single-cell analysis platform
European regulators have granted CE mark approval to LumaCyte's Radiance single-cell analysis instrument. The device uses laser force cytology technology to measure optical and fluidic forces within a microfluidic channel to analyze each cell's intrinsic cellular properties.
GenomeWeb Daily News (free registration) (9/12) 
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Camber Spine to debut Spira-O Open Matrix OLIF
Camber Spine's Spira-O Open Matrix OLIF, a spine implant for oblique lumbar interbody fusion surgery, is scheduled to be launched later this month. The implant will allow surgeons to reach multiple levels via one incision without the need for patient repositioning.
Becker's Spine Review (9/12) 
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Zimmer launches Stratum foot plating system
Zimmer Biomet has debuted its Stratum foot plating system, which allows hand-free application and is designed to decrease OR time and optimize usability.
Becker's Spine Review (9/12) 
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FDA clears GE Healthcare AI algorithms
The FDA has granted 510(k) clearance to GE Healthcare's AI algorithms, dubbed Critical Care Suite, embedded in a mobile X-ray device. The algorithms are intended to reduce the time required to assess chest X-rays for pneumothorax.
MassDevice (Boston) (9/12) 
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Food and Drug Law Institute (FDLI) Highlights
Food Advertising, Labeling, and Litigation Conference | September 26-27, Washington, DC
Food Advertising, Labeling, and Litigation Conference | September 26-27, Washington, DC
Join prominent practitioners and thought leaders from the food and dietary supplements industry for this two-day conference that will address the most pressing issues in advertising, labeling, and litigation. Register Now
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Introduction to Food Law and Regulation | September 24-25, Washington, DC
Introduction to Food Law and Regulation | September 24-25, Washington, DC
Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Register Now
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