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BioWorld - Tuesday, June 9, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
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Salix Coronary Artery

FDA clears Artrya’s AI-based coronary anatomy software

April 3, 2025
By Tamra Sami
The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.
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Globe isolated on white background with focus on Asia and Australia

Asia in firing line of Trump tariffs, but health care escapes largely unscathed

April 3, 2025
By Tamra Sami
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
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Caution tape displaying US flag, tariffs

Biopharma exempt from US reciprocal tariffs, but not untouched

April 3, 2025
By Mari Serebrov
At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.
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Medtronic, Recor commence hostilities over RDN patents

April 2, 2025
By Mark McCarty
The renal denervation patent wars are now in full swing, with subsidiaries of Medtronic plc and Recor Medical LLC, landing the first blow in this chapter of the med tech patent struggles.
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AI-generated digital horse illustration

MHRA’s AI Airlock program includes a generative AI tool

April 2, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled the pilot version of its AI Airlock in 2024, and the agency posted a list of the products that are taking part in this version of a regulatory sandbox.
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GE Healthcare

GE Healthcare taps into Japan radiopharma market with Nihon buy

April 2, 2025
By Marian (YoonJee) Chu
GE Healthcare Technologies Inc. gained full ownership of Nihon Medi-Physics Co. Ltd. after acquiring the remaining 50% stake from Sumitomo Chemical Co. Ltd. on March 31.
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Pills, bottle atop $100 bill

US to impose ‘kind reciprocal’ tariffs on country-by-country basis

April 2, 2025
By Mari Serebrov
After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.
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US flag and HHS logo

Kennedy called to Senate HELP hearing on HHS reorg

April 2, 2025
By Mari Serebrov
U.S. Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., invited Robert Kennedy to testify April 10 before the Senate Health, Education, Labor and Pensions (HELP) Committee for the first time in his capacity as Health and Human Services (HHS) secretary. The HELP invitation went out April 1 amid an outcry as thousands of employees across HHS agencies were being notified of their immediate termination and many lawmakers demanded answers about the mass layoffs.
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Illustration of lung cancer, DNA double helix

FDA clears Gleamer, Azmed AI-powered tools for chest X-rays

April 1, 2025
By Shani Alexander
Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.
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AI-generated illustration of DNA double helix

FTC eyeing 23andme’s disposition of genomic data

April 1, 2025
By Mark McCarty
The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.
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