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BioWorld - Sunday, June 15, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Gavel and scales

Resmed prevails over Cleveland Medical in CPAP patent review

May 7, 2025
By Mark McCarty
Few observers think of CPAP machines as common fare where the med-tech patent wars are concerned, but Resmed Corp. recently came away with a win in litigation that resulted in the nullification of the first 20 claims of a CPAP patent held by Cleveland Medical Inc.
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Microscope and coronavirus illustration

US-funded gain-of-function research paused for stiffer oversight

May 7, 2025
By Mari Serebrov
No Comments
In a throwback to the Obama administration, U.S. President Donald Trump signed an executive order pausing federally funded research using infectious pathogens and toxins that may pose a danger until a safer, more enforceable and transparent policy governing such research can be developed and implemented.
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AI-generated illustration of DNA double helix

Cellecta profiles 19,000 genes from a drop of blood

May 6, 2025
By Annette Boyle
Cellecta Inc. made remote diagnostics and decentralized clinical trials significantly easier with the launch of its Drivermap Exp assay. The microsampling kit provides a “molecular snapshot” of 19,000 human protein-encoding genes from just 30 microliters of dried whole blood.
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US flag, gavel, book

Q’apel’s withdrawal of Hippo ends patent lawsuit with Route 92

May 6, 2025
By Mark McCarty
Q’apel Medical Inc., of Fremont, Calif., might have thought the company’s withdrawal of the Hippo catheter was nothing but a loss, but Route 92 Medical Inc. managed to shine a positive light on the withdrawal by dropping a patent lawsuit against Q’apel because of the Hippo device.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 6, 2025
By Mari Serebrov
No Comments
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.
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Pharmaceutical manufacturing

EO offers US onshoring relief, FDA steps up foreign inspections

May 6, 2025
By Mari Serebrov
No Comments
In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.
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Gavel and scales

US states seek to undo HHS reorg, terminations

May 6, 2025
By Mari Serebrov
No Comments
Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court.
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Handshake with digital globe overlay

Med-tech financings and guidance strong despite tariffs

May 5, 2025
By Annette Boyle
April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but fundamentals and increased interest in med tech as a haven gave most players sufficient breathing room to absorb the impact with minimal adjustments.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 5, 2025
By Mari Serebrov
No Comments
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.
Read More
U.S. flag on columned building
MDMA annual meeting

Compliance still important under new Department of Justice

May 2, 2025
By Mark McCarty
The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.
Read More
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