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Home » Topics » Medical devices, BioWorld MedTech

Medical devices, BioWorld MedTech
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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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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The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response.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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Nandoun Abeysekera, founder and CEO, Avasa
Newco news

New Zealand’s Avasa develops world-first arterial coupler

March 19, 2025
By Tamra Sami
New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.
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3D illustration of Bivacor implanted in chest

Australian patient first to leave hospital with Bivacor TAH

March 13, 2025
By Tamra Sami
An Australian man in his 40s with severe heart failure was implanted with a Bivacor Inc. total artificial heart (TAH) and has been discharged from the hospital. He remained at home with the artificial heart for 100 days until he received a transplant earlier this week.
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Organox Metra platform

Organox raises $142M for liver transplant technology

Feb. 25, 2025
By Shani Alexander
Organox Ltd. raised $142 million in financing to accelerate the growth of its Metra platform that preserves and transport livers for transplantation. The funds will allow the company to strengthen its ability to support current customers, expand its customer base and enter new markets such as Canada and Australia, where it earned regulatory approvals within the last year, Steve Deitsch, CFO of Organox, told BioWorld.
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VAripulse

J&J resumes US Varipulse sales, but will it matter?

Feb. 18, 2025
By Annette Boyle
Nearly six weeks after Johnson & Johnson paused the U.S. external evaluation of its Varipulse pulsed field ablation catheter to investigate several neurovascular events in initial cases, the med-tech giant resumed its limited market release with revised global instructions for use.
Read More
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