Tag: surgery

Magtrace Nanoparticles for Sentimag System is FDA Approved for Breast Lymph Node Biopsy

The Food and Drug Administration approved Endomagnetics Inc.’s magnetic tracer injection and detection system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. In the procedure, the clinician injects a solution of dextran-coated iron oxide magnetic nanoparticles (Magtrace) in the viscinity of the tumour or the areola, as is done typically with […]

MACH 30 Ultrasound with ShearWave PLUS Elastography Cleared in U.S., Europe

SuperSonic Imagine, a French firm, has announced that its Aixplorer MACH 30 ultrasound has been cleared in the U.S. and Europe. The system works as a traditional high power ultrasound, but also features the company’s elastography technology called ShearWave PLUS that measures tissue elasticity, or stiffness, in 3D. Elastography is now commonly used for identifying mammary […]

DiLumen Stabilizes Scopes Within Large Intestine to Help Avoid Surgeries: Now Approved in Europe

Lumendi, a company based in Buckinghamshire, England, won European regulatory approval for its DiLumen Endolumenal Interventional Platform (EIP). The one-time-use device fits over typical endoscopes to provide stability when visualizing, diagnosing, and treating conditions within the large intestine. It works by inflating two balloons that squeeze against the lumen of the large intestine. One of the […]

Latest Air-Powered Robot for Breast Biopsies Inside MRI Unveiled (Video)

Most breast biopsies are currently performed using ultrasound and handheld needles, guided by previously taken radiological images. The problem is that humans aren’t always perfect and what is imaged during an MRI scan or mammography may look different later under ultrasound. Performing a biopsy right inside the MRI machine may provide incredibly accurate targeting of […]

Surgery-Free Hemodialysis Fistula Creation With everlinQ endoAVF

TVA Medical of Austin, Texas, a newly acquired subsidiary of Becton Dickinson, won de novo marketing clearance from the FDA for its innovative everlinQ endoAVF system for creating arteriovenous fistulas for hemodialysis without relying on open surgery. The system relies on catheters inserted into adjoining arteries and veins. When in proximity, built-in magnets within the catheters attract each […]

Novaerus Defend 1050 Uses Ultra-Low Energy Plasma to Disinfect Large Clinical Spaces

Novaerus, based in Ireland, is releasing a new hospital air filtration system that’s designed to be used in large rooms and where there’s a high chance for airborne transmission of pathogens. The Novaerus Defend 1050 uses “ultra-low energy plasma technology” and three separate filters, including HEPA and carbon/molecular filters, to remove nearly all infectious bugs […]

ExplORer Surgical Uses Workflows to Make Surgeries More Efficient

Surgeries are complex undertakings, with moving parts that include team members having multiple roles, specific protocols that must be followed, and dozens of tools and instruments that must be accounted for. ExplORer Surgical is a Chicago-based company that hopes to help better organize and manage these moving parts. ExplORer Surgical works by creating step-by-step “workflows” […]

Embolx Announces FDA Clearance for Next Generation Sniper Balloon Occlusion Microcatheter

Embolx, a new medical device company out of Silicon Valley, develops microcatheters for arterial endoembolization procedures, and now their next-generation Sniper Balloon Occlusion Microcatheter will be available in the US. The new family of microcatheters shows significant improvement over previous devices, and offers physicians enhanced performance features to make it easier to navigate through small […]

The World’s First Wireless, App-Based Ultrasound: Interview with Dr. Ryu, CEO of Healcerion

Healcerion, based in South Korea, was the first company to receive FDA clearance for a wireless, app-based ultrasound system back in 2015. The groundbreaking work done by South Korean engineers and scientists laid the foundation for the development of an ultrasound transducer that works with most smartphones or tablets. Since introducing the SONON 300C convex transducer, […]

Strained Guts: Engineering Human Intestinal Organoids for Transplantation

The increasing demand for organ transplantation has led many researchers to look for innovative ways to replace the need for human donors. Research in organoids, which are stem cell derived miniature mimics of organs typically grown in a dish, has significantly improved our understanding of organ development and structural organization. However, their size and simplicity […]

SOMAVAC 100, a Battery Powered Wearable Post Surgical Vacuum Pump

Some post-surgical wounds, including following abdominal surgeries and mastectomies, may require suction drainage to prevent post operative complications due to edema and fluid collections. Suction bulbs have been common for the past few decades, since they don’t require external power and are very simple in design. New technologies can significantly improve this, as batteries have […]

New Siemens Acuson Sequoia Ultrasound Beams Through Obese Patients

Siemens Healthineers is releasing a fresh update to its popular ACUSON Sequoia ultrasound system. The device can image deeper than before while maintaining a high quality output, an important capability for those on the front lines of the obesity epidemic. As an example, using the Deep Abdominal Transducer (DAX) that comes with the Sequoia, clinicians can […]

Grown Cartilage Used to Fix Diseased Joints Responsible for TMJ Dysfunction

Temporomandibular joint dysfunction (TMJ) is a condition which makes it difficult to chew on food and talk, while being quite painful and unpleasant. It’s caused by the breakdown of the cartilage disc that brings together two bones of the jaw. Researchers from University of California, Irvine, University of California, Davis, and The University of Texas School of […]

Photoacoustic Computed Tomography May Replace Mammographies for Breast Cancer Screening

Though mammography helps to provide early detection of breast cancer, it is a modality that suffers from limitations, particularly in dense breasts. A new technology, developed at Caltech, may have the potential to eclipse mammographies for spotting cancerous lesions. The photoacoustic system sends near-infrared laser light into breast tissue and detectors are used to spot […]

Thermoresponsive Hydrogel Bandage Conforms to Wound Shape and Stimulates Healing

Researchers at Northwestern University have developed a thermoresponsive hydrogel bandage. The hydrogel is liquid at room temperature, but changes into a semi-solid gel at body temperature when in contact with a wound, meaning it conforms to the wound shape. The gel contains an amino acid sequence that stimulates the body’s own healing process. The researchers […]

Sonavex’s EchoMark Soft Tissue Markers Receive FDA 510(k) Clearance

One year ago, we spoke with Sonavex CEO David Narrow about the Baltimore medical startup’s recent round of investment and ongoing development of its EchoMark and EchoSure products. At the time, David mentioned that the company was, “…preparing to submit our regulatory clearance materials.” This week, the company announced that it had secured FDA 510(k) […]

Health Technology Briefs from the ITF Demo Floor

Medgadget was recently invited to attend the imec Technology Forum (ITF) conference in Antwerp, Belgium. One of the highlights of the conference was the demo floor where imec, which is a non-profit R&D innovation organization, had the opportunity to show off some cool technologies from their research teams, spinoff companies, and partner organization. While the […]