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BioWorld - Saturday, June 13, 2026
Home » Topics » U.S., Medical technology

U.S., Medical technology
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Health care and politics illustration

Sen. Cassidy’s primary loss increases uncertainty

May 18, 2026
By Mari Serebrov
No Comments
On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.
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Patent gears

USPTO doubles down on inconsistencies in dual IPR-court action

May 14, 2026
By Mari Serebrov
No Comments
The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.
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China and U.S. flags

Life sciences ‘sweet’ opportunity in US-China talks

May 13, 2026
By Mari Serebrov
No Comments
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 12, 2026
By Mari Serebrov
No Comments
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
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Martin Makary, former FDA-commissioner

Makary out at the FDA

May 12, 2026
By Mari Serebrov
No Comments
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.
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Glean abdominal sensor

Bright Uro secures FDA approval for abdominal sensor

May 11, 2026
By Shani Alexander
No Comments
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multichannel urodynamic studies. The new sensor will allow clinicians to perform multichannel urodynamics, capturing both abdominal and detrusor pressures without the need for catheters, supporting treatment decision-making for patients with lower urinary tract dysfunction and other urological conditions.
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Mobia Medical Vivistim system

Mobia debuts on Nasdaq to bring stroke therapy to more patients

May 8, 2026
By Shani Alexander
No Comments
Mobia Medical Inc. began trading on Nasdaq under the ticker MOBI on May 8. The company priced its IPO at the midpoint of its proposed $14 to $16 range, selling 10 million shares at $15 each and raising approximately $150 million. The stock closed at $11.75 its first day of trading, down 21.7%.
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Roche building

Roche to acquire Pathai for up to $1.05B

May 7, 2026
By Shani Alexander
No Comments
Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.
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US FDA tries out 1-day inspections

May 7, 2026
By Mari Serebrov
No Comments
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 6, 2026
By Mari Serebrov
No Comments
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
Read More
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