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BioWorld - Friday, July 25, 2025
Home » Topics » Medical devices and technologies » Medical devices

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Korea Japan tech

Korea, Japan ink medical device info sharing pact

July 23, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety signed a confidentiality agreement with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to boost bilateral regulatory cooperation in the field of medical devices.
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DeepQure

Deepqure expands renal denervation trial to atrial fibrillation

July 22, 2025
By Marian (YoonJee) Chu
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
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Doctor with illustration of kidneys

CMS lists 6 specialists as part of hypertension team in RDN memo

July 15, 2025
By Mark McCarty
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.
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Cochlear Nuclea Nexa system

FDA green lights Cochlear’s smart cochlear implant

July 11, 2025
By Tamra Sami
Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.
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Oncosil

Oncosil’s brachytherapy device outperforms SBRT in pancreatic cancer

May 8, 2025
By Tamra Sami
Oncosil Medical Ltd.’s brachytherapy device outperformed stereotactic body radiation therapy plus chemotherapy in patients with unresectable or borderline-resectable locally advanced pancreatic cancer, according to a comparative analysis.
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Approved stamp

South Korea approves record number of biosimilars in 2024

May 6, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Approved stamp

South Korea approves record number of biosimilars in 2024

April 30, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Mark Cook with Minder implant

Epiminder wins de novo clearance for epilepsy EEG monitor

April 24, 2025
By Tamra Sami
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
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Illustration of human body composed of molecules

Device makers wary of FDA guidance for AI-enabled software functions

April 21, 2025
By Mark McCarty
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
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KIMES 2025
KIMES 2025

Trio of neuro disease-focused firms highlighted at KIMES 2025

March 25, 2025
By Marian (YoonJee) Chu
At the four-day KIMES 2025 exhibition, more than 35,000 products and prototypes were on display. In the clamor, BioWorld engaged with three promising neurological disease-focused companies – Readycure Inc., Neurive Co. Ltd. and Vuno Inc. – that showcased innovative technology for conditions like Alzheimer’s disease and tinnitus at the Seoul-based event.
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