For Some Companies, Puerto Rico Financial Impact Uncertain

Lantheus Holdings, Becton Dickinson are among manufacturers to say in recent financial reports that the hurricane has ongoing impacts for the companies.

Gerald Herbert/AP
Damage from Hurricane Maria in Toa Alta, Puerto Rico • Source: Gerald Herbert/Associated Press (Gerald Herbert/AP)

While Hurricane Maria hit Puerto Rico six weeks ago, its full financial impact is yet to be felt by some device manufacturers, according to quarterly earnings reports from companies over the past week.

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China Strikes Back After Trump Ups Tariffs; Administration Further Delays Tariffs On Canada And Mexico

 

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.

PathAI Enters South American Market Partnering With Integrated Healthcare Network Rede D’or

 

PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.

Could A Wider Trade War Be Brewing? Beijing Retaliates With Own Tariffs While AdvaMed Asks Administration For Exemption

 

Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices

 

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

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Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
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The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.