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BioWorld - Saturday, May 30, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Korea ARPA-H roundtable

Korean ARPA-H to invest ₩162B in nine projects in 2026

March 6, 2026
By Marian (YoonJee) Chu
No Comments
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
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Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 4, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
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Abbott Laboratories Aveir VR leadless pacemaker system

NICE recommends leadless pacemakers to treat slow heart rhythms

March 2, 2026
By Shani Alexander
No Comments
The U.K.’s National Institute for Health and Care Excellence (NICE) recommendation that leadless cardiac pacemakers be used as the standard of care for people with slow heart rhythms (bradyarrhythmias) is a boon for more than 2 million individuals living with the condition. The use of the technology will transform patients’ quality of life, reduce rates of infections and lower costs for the health care system.
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Allurion swallowable gastric balloon

FDA approves Allurion’s gastric balloon system

Feb. 26, 2026
By Shani Alexander
No Comments
The U.S. FDA approved Allurion Technologies Inc.’s premarket application for its swallowable gastric balloon system, which features its Smart Capsule, for weight loss. The clearance is boon for the company as GLP-1 agonists gets increasingly adopted to treat obesity. The approval also brings to the market a new non-invasive option to patients looking for alternative ways to lose weight.
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Prescription drug bottles and pills

US GAO: March-ins not much of a solution for Rx prices

Feb. 19, 2026
By Mari Serebrov
No Comments
Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.
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MHRA proposes path forward for CE-marked devices

Feb. 18, 2026
By Mari Serebrov
No Comments
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030.
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Medtronic to pay Applied Medical $382M in antitrust ruling

Feb. 6, 2026
By Shani Alexander
No Comments
A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
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Abbott Laboratories’ Cardiomems HF system

UK’s NICE recommends Abbott’s Cardiomems heart failure system

Feb. 5, 2026
By Shani Alexander
No Comments
The U.K.’s National Institute for Health and Care Excellence (NICE) has recommended the use of Abbott Laboratories’ Cardiomems HF system, giving people living with heart failure an option to monitor their condition daily from home. The implantable wireless sensor could transform care for individuals with the chronic condition as it will enable them to catch early warning signs before they escalate to medical emergencies.
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FDA updates cybersecurity guidance for medical devices

Feb. 4, 2026
No Comments
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
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Medicare puzzle

CMS rewrites organ procurement rule to expand availability

Jan. 30, 2026
By Mark McCarty
A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a problem qualifies as an adverse event. Perhaps of greater interest to companies in the organ container business is that the Centers for Medicare & Medicaid Services is intent on increasing the availability of organ donations to deal with an insatiable demand for donated organs.
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