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BioWorld - Saturday, December 27, 2025
Home » Topics » Urology, BioWorld MedTech

Urology, BioWorld MedTech
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Illustration of kidney cancer showing tumor inside the kidney

Roche secures CE mark for kidney disease algorithm

Oct. 8, 2025
By Shani Alexander
Roche Holdings AG received CE-mark for the Kidney Klinrisk algorithm, an AI-based tool developed in collaboration with Klinrisk Inc. to stratify risk and assess the progressive decline in kidney function. The software will help clinicians to make more informed decisions when accessing adults with chronic kidney disease as well as individuals with diabetes or hypertension who are at elevated risk of kidney function decline.
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Medtronic Altaviva

Medtronic's Altaviva bags FDA approval for incontinence

Sep. 19, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.
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Organox metra

Organox liver perfusion device cleared by FDA during air transport

Sep. 19, 2025
By Shani Alexander
Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of donor organs that might otherwise be discarded, as the Metra system circulates oxygen and nutrient rich perfusate through the organ at near-body temperature, extending preservation times.
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Gold Euro symbol on blue background

Teleflex closes $879M Biotrinik buy, wraps strong Q2

Aug. 4, 2025
By Annette Boyle
Good news bracketed July for Teleflex Inc. as it completed the acquisition of the vascular intervention business of Berlin-based Biotronik SE & Co. for €760 million (US$879 million) on July 1 and released stronger-than-expected second quarter results on the closing day of the month. Both bode well for the company as it proceeds through a thorough restructuring announced in February.
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Uroactive smart implant

Uromems gets OK for Uroactive stress urinary incontinence trial

July 17, 2025
By Shani Alexander
Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.
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Caverstim system

Comphya secures $8.4M for implantable neurostimulation ED therapy

July 14, 2025
By Shani Alexander
Comphya SA raised CHF 7.5 million (US$ 8.4 million) in a series A round for its implantable neurostimulation therapy, Caverstim, which treats men with erectile dysfunction who do not respond to medication.
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Medicare puzzle

CMS formally proposes to terminate ESRD choices program

July 8, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
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Accunea monitoring device

Accunea’s Renosure device can save kidneys from being discarded

July 7, 2025
By Shani Alexander
Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
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Illustration of kidneys with DNA double helix

Vantive to invest $1B in digital kidney support therapies

June 3, 2025
By Annette Boyle
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
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Phraxis Endoforce

Phraxis Endoforce receives FDA approval for anastomosis

May 23, 2025
By Annette Boyle
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
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