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        GE Healthcare has received FDA 510(k) clearance for its SIGNA MAGNUS, a 3.0 trillion high-performance, head-only MRI scanner designed for neuroimaging. The scanner features an asymmetrical head-only gradient coil design that provides better patient head access and higher gradient performance than conventional whole-body MRI systems.
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        The system's HyperG gradient technology operates at 300mT/m and 750 trillion/m/s, enabling faster image acquisition without increased power requirements. It includes oscillating gradient diffusion encoding (ODEN) technology for improved brain function, microstructure, and micro-vasculature visualization.
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        SIGNA MAGNUS will be available for new installations and as an upgrade from compatible SIGNA Premier systems. Four investigational scanners are currently installed at various institutions, including Walter Reed National Military Medical Center and the University of Iowa.
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    <a href="https://www.medicaldevice-network.com/news/ge-healthcare-mri-fda/?cf-view">
      Medical Device Network
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Next-gen Medical Devices

INCUMBENTS_PRESENT

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 <p>GE Healthcare has gotten FDA 510(k) clearance for their new high-performance, head-only MRI scanner known as SIGNA MAGNUS, which is specifically designed for neuroimaging. The scanner boasts a unique asymmetrical head-only gradient coil design, as this provides better access to patients' head and offers superior gradient performance than typical whole-body MRI systems.</p>
 <p>The SIGNA MAGNUS incorporates the HyperG gradient technology that operates at 300mT/m and 750 trillion/m/s, providing a quick image capture without needing an increase in power requirements. The system incorporates the oscillating gradient diffusion encoding (ODEN) technology that enhances brain function, microstructure, and micro-vasculature visibility.</p>
 <p>The SIGNA MAGNUS can be installed as a new system or as an upgrade from compatible SIGNA Premier systems. Currently, four investigative scanners have been installed at various institutions, some being the Walter Reed National Military Medical Center and the University of Iowa.</p>
 
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GE Healthcare receives FDA clearance for SIGNA MAGNUS MRI scanner

ANALYST_QUICK_TAKE

<div>
 <p>Momentis Surgical has gained FDA approval for its updated Anovo robotic surgical system. This modernised platform, equipped with miniature humanoid-shaped robotic arms, is the first of its kind to earn FDA clearance for operation in both retroflexion and anteflexion.</p>
 <p>New improvements to the system include integrated haptic feedback for easier handling, advanced ergonomics, and a video overlay system featuring annotation enabling enhanced team communication. Previously, the system had been certified only for single-site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.</p>
 </div> <p><b>Analyst QuickTake:<br>
 </b> Several FDA approvals for next-gen medical devices were seen in the recent past. In <a href="https:<br>
//sp-edge.com/updates/34840"> October 2024, </a> CMR Surgical received FDA marketing clearance for its Versius surgical robotic system. In <a href="https:<br>
//sp-edge.com/updates/34104"> August 2024 </a> , THINK Surgical's TMINI Miniature Robotic System was cleared for use with Medacta International’s GMK Sphere and SpheriKA Knee Systems.</p>

Momentis Surgical receives FDA clearance for second-gen Anovo surgical robot

<div>
 <p>ZAP Surgical Systems, a radiosurgery system enterprise, has successfully raised a sum of USD 78 million in a Series E funding round. The funding round was spearheaded by Qingdao Baheal Medica, along with contributions from other strategic investors.</p>
 <p>The additional financing will be allocated towards the continued commercialization of ZAP Surgical Systems' ZAP-X Gyroscopic Radiosurgery platform. This platform is an intricate cranial radiosurgery system.</p>
</div>

ZAP Surgical raises USD 78 million in Series E funding to advance commercialization

<div>
 <p>Akura Medical has been given FDA Investigational Device Exemption (IDE) approval to initiate the QUADRA-PE study for testing its Katana Thrombectomy System on patients suffering from acute pulmonary embolism. This large-scale international trial will cover 26 global sites and envisions the enrollment of about 118 patients.</p>
 <p>Incuding features like a bidirectional low-profile sheath, high-speed saline jets for clot degradation, sensors for real-time checking of pulmonary artery pressure, and the Sentinel console to monitor clot engagement and blood loss, the Katana System will be evaluated for efficiency by measuring the reduction in the right ventricular/left ventricular ratio and its safety by keeping track of major adverse events.</p>
 <p>As of now, the system is only intended for investigational use and has not been given clearance for sale in the US or other countries. Columbia University Medical Center and Tristar Centennial Medical Center will jointly lead the trial.</p>
</div>

Akura Medical receives FDA approval for pulmonary embolism trial

<div>
 <p>The medical technology firm Boston Scientific Corporation is set to acquire Cortex, Inc., a company specialising in diagnostic mapping solutions for atrial fibrillation (AF). The acquisition will be for an unknown amount. </p>
 <p>The OptiMap System, a product developed by Cortex, utilises a basket catheter and a unique algorithm to identify potential sources of active AF. The system assists practitioners in creating ablation strategies tailored to individual patients. After gaining FDA 510(k) clearance in 2023, the system showed a 51% increase in AF freedom compared to traditional therapy in clinical trials.</p>
 <p>The acquisition, which is expected to be finalised in the first half of 2025, is set to enhance Boston Scientific's electrophysiology portfolio. This will be achieved through the addition of distinct cardiac mapping technology for intricate AF cases. The acquisition also includes plans for furthering the technology and expanding its global reach.</p>
 
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Boston Scientific to acquire Cortex for undisclosed sum

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 <p>Larry Jones, the Chief Information Officer (CIO) of Johnson &amp; Johnson (J&amp;J) Medtech, has announced his departure from the company after a service period of 35 years. His retirement takes effect from November 15.</p>
 <p>In his recent duty, Jones spearheaded the implementation of digital surgery connectivity solutions pertaining to surgical robots and machine learning platforms at J&amp;J Medtech.</p>
 <p>Prior to his position at J&amp;J Medtech, Jones had been the global CIO for Janssen Pharmaceuticals, the research subsidiary of J&amp;J specializing in drugs. His plans post-retirement have not been disclosed, but he expressed his dedication towards leveraging technology to achieve better global health equity and battle chronic diseases.</p>
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Johnson & Johnson Medtech CIO Larry Jones to retire

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<p>Diagnostic device firm, Sonavex, has secured a Series A-2 funding round, receiving 15 million in investments. This funding round saw the participation of new investors such as Unorthodox Ventures, GenHenn Capital, JSTAR Capital, and Partners Investment. The firm's existing shareholders also participated.</p>

<p>The new funds will be directed towards further evidence generation for Sonavex's EchoMark and EchoSure platforms. The developments will be supported by an ongoing randomized controlled trial known as MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).</p>

<p>Established as a Johns Hopkins spinout, Sonavex specializes in developing ultrasound technologies that produce quantitative blood flow and other crucial vascular data at the point of care. The EchoMark and EchoMark LP (Low Profile) technologies are FDA-approved echogenic, resorbable polymeric implants, intended for soft tissue marking in surgical patients. These devices feature distinctive ultrasound reflective properties and a three-dimensional form that allows for precision in marking surgical sites. This accuracy facilitates more superior ultrasound visualization during follow-up evaluations post-surgery.</p>

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Sonavex raises USD 15 million in Series A-2 funding to support clinical trials

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 <p>Daiki, an AI-powered medical device compliance software provider, has successfully garnered EUR 1.5 million (USD 1.6 million) in seed funding directed by Humanitas GmbH.</p>
 <p>This recent funding will be utilized to speed up development plans, which includes integrating a new AI model registry feature. It will also aid in expanding the team and fortifying the company's market position across Europe.</p>
 <p>Daiki, located in Vienna, delivers software solutions for AI governance and compliance aligned with the EU AI Act and ISO standards. Its main clientele are in the medical technology, healthcare, and manufacturing sectors, specifically focusing on the DACH region, UK, Netherlands, and Scandinavia.</p>

</div> <p><b>Analyst Quicktake:<br>
 </b> Earlier in <a href="https:<br>
//sp-edge.com/updates/34162"> September 2024 </a> , Flinn.ai, also a Vienna-based medical device compliance software provider, raised EUR 10 million (~USD 11 million) for market and product expansion. This reflects the increasing demand for regulatory compliance and quality management tools across Europe's medical device industry.</p>

Daiki raises EUR 1.5 million in seed funding to accelerate growth

PROMINENT_CATEGORY

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 <p>Proximie, a health technology platform, has partnered with Olympus to facilitate live collaboration and knowledge sharing in operating rooms. The integration enables physicians to share live audio, video, and imagery from surgeries with global teams via Proximie's cloud-based platform. Its features include high-definition video streaming, annotation tools, and content management capabilities, all accessible from any internet-enabled device.</p>
 
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Proximie partners with Olympus to digitize operating rooms

<div>
 <p>Medical device firm Hologic, which specializes in women's health, has purchased Gynesonics, another medical device company, for $350 million. This transaction is subject to standard closing adjustments. </p>
 <p>This acquisition is intended to augment Hologic's portfolio and provide gynecologist surgeons with a more comprehensive range of minimally invasive treatment options. These are primarily for women experiencing heavy periods and fibroids. </p>
 <p>Gynesonics has been recognized for creating the Sonata System. This system merges real-time intrauterine ultrasound guidance with focused radiofrequency ablation for the transcervical treatment of certain symptomatic uterine fibroids. These fibroids include those associated with heavy menstrual bleeding. </p> 
</div>

All Updates

GE Healthcare receives FDA clearance for SIGNA MAGNUS MRI scanner

Momentis Surgical receives FDA clearance for second-gen Anovo surgical robot

ZAP Surgical raises USD 78 million in Series E funding to advance commercialization

Akura Medical receives FDA approval for pulmonary embolism trial

Boston Scientific to acquire Cortex for undisclosed sum

Johnson & Johnson Medtech CIO Larry Jones to retire

Sonavex raises USD 15 million in Series A-2 funding to support clinical trials

Daiki raises EUR 1.5 million in seed funding to accelerate growth

Proximie partners with Olympus to digitize operating rooms

Hologic to acquire Gynesonics for USD 350 million to expand its fibroid treatment solutions

Next-gen Medical Devices

GE Healthcare receives FDA clearance for SIGNA MAGNUS MRI scanner

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