MedTech News Briefs | March 11th, 2024

  1. GE Healthcare has unveiled data showcasing the effectiveness of its AI models in predicting patient responses to cancer immunotherapies, achieving an accuracy rate of 70% to 80% in a pan-cancer cohort. Utilizing electronic health record (EHR) data, the models aim to forecast the efficacy and toxicity of immunotherapy, drawing primarily on structured data readily available in medical records. Developed in collaboration with Vanderbilt University Medical Center (VUMC), the models could potentially assist clinicians in selecting optimal treatment pathways and minimizing unnecessary side effects, with plans for future commercialization pending regulatory approval.
  2. BD has initiated the AGILITY study, enrolling the first patient to evaluate the safety and efficacy of its Vascular Covered Stent for treating peripheral arterial disease (PAD). The global study will involve 315 patients across multiple trial sites and aims to assess the performance of the low-profile, self-expanding stent in improving patient outcomes over a follow-up period of up to 36 months. BD’s Vascular Covered Stent offers a potential solution to address the unmet needs in PAD treatment, providing interventionalists with a differentiated technology to enhance patient care.
  3. Virtual Incision Corporation has received FDA authorization for its miniaturized robotic-assisted surgery device, Mira Surgical System, through the De Novo premarket review pathway. The device, designed for colon mobilization in adults undergoing minimally invasive colectomy procedures, offers practical advantages such as portability and short setup time, revolutionizing surgical robotics with its internal approach and handheld features. With plans for expanded indications and a controlled rollout, Virtual Incision aims to address unmet needs in surgery while potentially offering cost-effective solutions compared to existing robotic technologies.
  4. ResMed launches the AirFit F40 ultra-compact, full-face mask for sleep apnea therapy, designed to offer comfort and performance for users of high-pressure CPAP treatment. With features like the AdaptiSeal cushion and a flexible frame, the mask aims to improve compliance and seal effectiveness while providing a minimalist design suitable for side sleepers and claustrophobic users.
  5. Researchers from Northwestern University and Washington University School of Medicine have developed a revolutionary sticker that changes shape in response to pH changes in the body, providing early detection of post-surgery complications like anastomotic leaks. The sticker, applied to organs, can be monitored via ultrasound, offering a non-invasive method to detect leaks, potentially saving lives and improving patient outcomes. The bioresorbable sticker dissolves naturally after use, avoiding the need for surgical removal, and could pave the way for further advancements in detecting internal health changes.

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Sources:

  1. https://www.massdevice.com/ge-healthcare-ai-model-responses-immunotherapy/
  2. https://www.medicaldevice-network.com/news/bd-pad-vascular-stent/
  3. https://www.mddionline.com/medical-device-regulations/fda-grants-de-novo-authorization-for-virtual-incision-mira-surgical-system
  4. https://www.massdevice.com/resmed-launches-sleep-apnea-face-mask/
  5. https://www.medicaldesigndevelopment.com/topics/imaging/news/22889509/shapeshifting-ultrasound-stickers-detect-postsurgical-complications

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