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Stanford adopts Kallisio’s Stentra to improve reproducibility in IMRT for head and neck patients
Medical Devices & Diagnostics

Kallisio’s Stentra system enters clinical use at Stanford, expanding precision radiation toolkit for head and neck cancer

Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation

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Medical Devices & Diagnostics

Can Establishment Labs shift the breast reconstruction standard in the U.S. with Motiva?

Find out how Establishment Labs is aiming to transform U.S. breast reconstruction with Motiva implants and FDA approval. Read what changes and risks lie ahead.

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Medical Devices & Diagnostics

KORU Medical seeks FDA clearance to expand FreedomEDGE into HER2+ breast cancer treatment

KORU Medical’s FDA filing to clear FreedomEDGE for PHESGO delivery could reshape cancer infusion workflows. Find out what it means for oncology care.

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A representative image illustrating spinal cord stimulation using waveform-based programming, relevant to new research on personalized chronic pain therapy by Soin Neuroscience and BIOTRONIK Neuro.
Medical Devices & Diagnostics

What BIOTRONIK’s partnership with Soin Neuroscience reveals about the future of neuromodulation

Soin Neuroscience and BIOTRONIK Neuro have announced a research collaboration focused on evaluating novel waveform technology and adaptive spinal cord stimulation programming aimed at enhancing chronic pain treatment outcomes. The partnership integrates proprietary signal tuning algorithms from Soin Neuroscience with the programmable Prospera SCS system developed by BIOTRONIK Neuro, reinforcing a broader industry shift toward

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Medical Devices & Diagnostics

May Health’s Anavi System CE Mark highlights a new middle ground in PCOS infertility treatment

May Health’s Anavi System wins CE Mark. Find out what this means for PCOS infertility care, clinical adoption, and regulatory pathways in Europe.

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Medical Devices & Diagnostics

Detect-ION, Mayo Clinic join forces to develop non-invasive pneumonia breath test

Detect-ION, a diagnostics-focused startup based in Tampa, Florida, has announced a collaborative project with the Infectious Diseases Division at Mayo Clinic Florida to develop a non-invasive breath test for detecting Pseudomonas aeruginosa, a leading cause of pneumonia in vulnerable patient populations. Funded through the Mayo Clinic Advanced Innovation Research program, the project aims to address

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Medical Devices & Diagnostics

Ruthless Spine’s RJB device approved in Israel, expanding navigation tech reach

Gad Medical Ltd. has received regulatory clearance in Israel to commence commercial distribution of the RJB intraoperative angle measurement system from Ruthless Spine, a United States-based medical technology company. This milestone follows the companies’ earlier distribution agreement and paves the way for hospitals and surgical centers across Israel to integrate the RJB platform into thoracolumbar

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Medical Devices & Diagnostics

What Nitinotes’ EASE trial tells us about the future of bariatric endoscopy

Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits

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Medical Devices & Diagnostics

Can Roivios’ JuxtaFlow device redefine kidney support in heart failure and cardiac surgery patients?

Roivios Ltd., a clinical-stage medical device developer, has announced encouraging results from its first-in-human study of the JuxtaFlow Renal Assist Device, a technology designed to support fluid removal and renal function in patients with diuretic-resistant cardiorenal syndrome and acute decompensated heart failure. The results, published in the ASAIO Journal, showed that JuxtaFlow significantly improved both

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