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BioWorld - Friday, June 20, 2025
Home » Topics » Medical devices and technologies

Medical devices and technologies
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Hands holding torn contract

Masimo-Politan mudslinging gets messier

July 5, 2024
By Annette Boyle
The years’ long effort by activist investor Politan Capital Management LP to take control of the Masimo Corp. board of directors and oust Masimo CEO and founder Joe Kiani took a turn for the weird this week as news emerged that Masimo Chief Operating Officer Bilal Muhsin notified the board that he would step down if Kiani were pushed out.
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Ykrita ectopic liver device
Patents

Ykrita enhances IP for its artificial ectopic liver device

June 19, 2024
By Simon Kerton
In just its second PCT filing, Ykrita Lifesciences Private Ltd. (YLS) continues to assemble intellectual property for its development of an extracorporeal bioengineered dual-cell liver regeneration (EBDLR) system which serves as a lightweight, portable, ectopic liver device to aid in the rejuvenation of the body’s own liver and treat acute liver failure without the need for surgery.
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Amber Therapeutics
Patents

Amber Therapeutics exploring alternative uses for bioelectric device

April 3, 2024
By Simon Kerton
In a departure from its focus on using implanted electrodes to treat urinary incontinence, Amber Therapeutics Ltd. has filed for protection of similar approaches to treat sexual dysfunction and pelvic pain.
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White paper delves into US regulatory aspects of AI in drug, device development

Sep. 7, 2023
By Mari Serebrov
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
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DBS for stroke

EDEN trial shows DBS improves movement in stroke patients

Aug. 25, 2023
By Annette Boyle
A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities up to three years after a stroke. Results of the study were published in Nature Medicine.
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EU flags at European Commission building

The EC releases update on MDR-IVDR applications and certification

Aug. 24, 2023
By Bernard Banga
The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).
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Medtronic - Symplicty Spyral HTN

Divergent trial results tank Medtronic’s Symplicity Spyral at FDA advisory

Aug. 24, 2023
By Mark McCarty
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
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Sycamore device from Safe Orthopaedics

Safe Orthopaedics unveils promising device for vertebral compression fractures

Aug. 23, 2023
By Bernard Banga
Safe Orthopaedics SAS reported results from a biomechanical study comparing its new surgical technique Sycamore – a pedicle-anchored implant – with standalone balloon kyphoplasty. The results published in summer 2023 in the Journal of Experimental Orthopaedics showed a “significant increase” in compression strength with patients using Sycamore.
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Levita Magnetics’ MARS system

FDA gives Levita a lift to MARS with surgery system clearance

Aug. 23, 2023
By Annette Boyle
Levita Magnetics International Corp. received uplifting news this week as the U.S. FDA cleared its magnetic-Assisted Robotic Surgery (MARS) minimally invasive surgical platform. MARS builds on the company’s first product, the Levita magnetic surgical system, by providing greater control of surgical instruments to surgeons. The platform is cleared for use in bariatric, colorectal, gallbladder and prostate surgeries.
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Recor Medicaal Paradise renal denervation catheter

Recor snares supportive vote from FDA advisory panel for Paradise renal denervation device

Aug. 23, 2023
By Mark McCarty
The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S.
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