Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
In what represents the first patenting from Glasgow-based Microplate Dx Ltd., three of its co-founders describe a system for diagnosing microbial infections and performing rapid antimicrobial susceptibility testing, enabling quicker and more precise determination of effective antibiotics.
Nine out of 10 people with chronic kidney disease have no idea their kidneys are impaired, largely because of a lack of routine testing for albuminuria, one of the earliest biomarker for the disease.
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage renal disease to receive their treatment in the comfort of their own homes and without a rigid dialysis schedule.
Tokyo-based Olympus Corp. launched a new video imaging platform called Visera S (OTV-S500) in Europe and select Asian countries September 2024 while advancing more rollouts for the product worldwide.
Stimvia s.r.o. recently secured Medical Device Regulation certification for its Uris neuromodulation system to deliver both percutaneous tibial nerve stimulation and peroneal electrical transcutaneous neuromodulation to treat lower urinary tract symptoms.
More than 18 months after announcing plans to spin off its kidney care division as a standalone public company, Baxter International Inc. reached an agreement to sell the business for $3.8 billion to global equity investor Carlyle and Atmas Health instead. The transaction is expected to close in late 2024 or the first quarter of 2025.
The recent €15 million (US$16.3 million) deal that Affluent Medical SAS signed with Edwards Lifesciences Inc. for its heart products does not take away from its ambitions of creating a European med-tech company, Sébastien Ladet, CEO of Affluent Medical, told BioWorld, but was part of the company’s broader strategy to expand the markets for its products.
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