Scopio Labs, developer of Full-Field Digital Cell Morphology imaging and analysis platforms, as well as digital morphology, has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.

This marks a pivotal moment, establishing a new regulatory category for all-digital bone marrow aspirate analysis software. Prior, Vietnam showed off its success in using additive manufacturing to save a teenager with bone cancer.

Bone marrow cytology, the microscopic analysis of cells in bone marrow samples, remains a crucial diagnostic tool for a wide range of blood disorders. Hematologic malignancies account for about 10% of all diagnosed cancers in the U.S. and remain a leading cause of the global cancer burden.

Bone marrow aspirate (BMA) plays a vital role in diagnosing these and other hematologic conditions, both malignant and benign. However, traditional manual methods are labor-intensive, time-consuming, and heavily reliant on highly skilled hematopathologists to ensure accuracy.

Scopio’s FF-BMA Application transforms BMA analysis by introducing a fully digital workflow that seamlessly integrates with Scopio’s X100 and X100HT platforms. By combining high-resolution full-field imaging with a robust AI-powered decision support system (DSS), this solution aims to significantly benefit healthcare professionals and patients.

It enables hematopathologists to access and review bone marrow smears remotely (via a secure hospital network), reducing turnaround time, fostering collaboration, facilitating expert second opinions, and bolstering diagnostic confidence.

“We commend the FDA for acknowledging the essential need to support hematology experts in their complex work,” said Itai Hayut, CEO of Scopio Labs. “The approval of the FF-BMA Application arms them with robust decision support systems. By harnessing AI and Full-Field imaging, labs can streamline workflows, reduce operational costs, and enhance patient care.”

“Scopio’s FF-BMA Application addresses the urgent need for digital innovation amid the rising prevalence of hematologic conditions and healthcare demands,” said Adam Bagg, MD, a Professor of Pathology and Laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania and a lead investigator in the BMA study that was submitted to the FDA. “By optimising digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board.”

The FF-BMA Application is designed to assist trained operators in streamlining BMA review and reporting. It automates the detection and visualization of hematopoietic cells in stained smears, thus facilitating essential evaluations such as bone marrow smear quality assessment, blast cell and plasma cell estimation, and calculation of the myeloid to erythroid (M:E) ratio. This innovative tool aims to standardise BMA analysis, elevate diagnostic precision, and ultimately improve patient care.

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3D printing solutions by Stratasys Ltd used by the University Hospital Birmingham in England is delivering improved outcomes for head and neck cancer patients, with the institute reporting reduced surgery times by up to three hours through the use of tailored, 3D printed cutting guides.

This 3D printing success is attributed to the integration of a Stratasys J5 MediJet 3D printer that enables the hospital to create highly accurate, patient-specific cutting guides ahead of operations, transforming the way tumors are removed from head and neck cancer patients. Previously, these would have been created by cutting and bending a piece of metal by hand while the patient was on the operating table, resulting in a time-consuming process with a large margin for error.

Surgical Precision With 3D Printing Technology

Using 3D printing, the surgical team can now produce highly accurate devices using patient scans, with a resolution of within 150 microns, helping to support surgical outcomes. These are produced in Biocompatible Clear MED610; a rigid, transparent resin suitable for applications requiring long-term contact (more than 30 days) with intact skin and limited contact (up to 24 hours) with tissue, bone or mucosal membranes.

Read more here at page 46

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The post 3D Printing Quickens Craniomaxillofacial Tumour Surgery appeared first on Asia Pacific Metalworking Equipment News | Manufacturing | Automation | Quality Control.

Typically, when cancer tumours are in complicated areas, patients are often at high risk of death during surgery, even in advanced nations. In this case, the large tumour was found to be in the patient’s pelvic floor.

Vietnam encounters only between five and ten similar cases each year — accounting for 5% of bone cancer cases. The patient suffered numbness in the pelvic area, limiting his movement and gait. Several consultations with doctors concluded with prognosis of mild soft tissue injuries incurred from playing sports, despite the huge protrusion.

Image credit – Vinmec International Hospital

Vinmec’s medical experts realised the cancerous tumour is supplied by a large and complex vascular system, resulting in possible loss of up to 10 litres of blood during surgery. On the other hand, the tumour’s compression on vital organs such as the digestive system, urinary system, spine, pelvis, and blood vessels was a challenge to approach.

In a case of hemorrhage, it would lead to an uncontrollable situation without clearly revealing the tumour and related parts. However, without surgery, the patient would face the risk of left leg muscle atrophy, and eventually death.

Additive Manufacturing — Prelude To Procedure

The technology greatly help the medical team plan the procedure by printing the tumour, consequently, providing a visual and accurate assessment of shape, volume, and correlation with vital organs. Based on that, doctors could plan the operative approach and minimise complications. 

3D-printed tumor model with a 1:1 ratio to help doctors plan precise surgery

Prior to the surgery, the radiologists embolised large blood vessels of the tumor to minimise blood loss during surgery. The next day, cardiologists, gastroenterologists, and urologists participated in the initial phase of surgery. Cardiologists exposed and controlled the iliac artery, and may perform ligation when bleeding is severe. The urologist then released the bladder and ureters from the tumor, and the gastroenterologist performed a dissection to protect the digestive tract. 

Orthopedic experts removed the tumour through two incisions in the abdomen and behind the thigh. During the major surgery, the team of anesthesiologists continuously monitored and adjusted to maintain a stable state and minimise post-operative complications simultaneously. The team that participated in this major procedure comprised over 30 medical professionals. The process took 8 hours.

The patient resumed normal activities after three days and was discharged a week after. However, he was advised to wait for the pathology results is necessary to consider radiotherapy, but it is only an additional method. In this case, successful surgery is the best treatment for cancer.

Currently, there are few centers in the world applying 3D printing technology to disease models for preoperative planning of complex cases. Vinmec is the first and only unit to carry this technology in Vietnam. Presently, 100% of bone, joint, and cancer surgeries at Vinmec are performed in the same process: a virtual surgery (on the software), an experimental surgery (on the model), and then an actual surgery (on the patient).

Prof. Ph.D. Dr. Tran Trung Dung – Director of the Center for  Orthopedics and Sports Medicine, Vinmec International Hospital

Prof. Ph.D. Dr. Tran Trung Dung – Director of the Center for Orthopedics and Sports Medicine, Vinmec International Hospital said: “The giant bone tumour in the pelvis (like a pregnant woman) compressed the left sciatic nerve, causing numbness and left leg atrophy. Untimely treatment leads to loss of function in the left leg, and is even life-threatening.

”Due to the increased size of the tumour, it would compress and cause blockage in the digestive or urinary system. Therefore, it is necessary to remove early to help restore limb function and avoid distant complications of the digestive and urinary systems.”

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Source: Vietnam News Agency (VNA)

Robotic surgery has become increasingly popular in Vietnam in recent years, and many hospitals and medical centers now offer robotic surgical procedures using advanced robotic systems such as the da Vinci Surgical System. According to Vietnam Times, the da Vinci Surgical System is currently among the world’s most advanced robotic surgery system, has been applied in K Hospital.

Robotic surgery systems offer precise, accurate, and easily replicated results that can greatly assist surgeons and improve patient outcomes. The da Vinci Surgical System allows surgeons to perform various minimally invasive procedures with clinically supported precision and accuracy.

The system applies to a wide array of operations, including minimally invasive cardiac, colorectal, gynecology, head and neck, thoracic, urology, and general surgeries. The surgeon operates via the Surgeon Console that controls the Patient Cart’s robotic devices, including various surgical instruments and a camera.

Over 1,700 da Vinci Systems are currently installed in hospitals internationally, and more than 775,000 patients have received procedures from this robotic surgical system.

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Source: Netherlands Cancer Institute

Tumors in and around the lower jaw are often treated by removing part of the jaw bone (mandible). The mandible is reconstructed, if possible, with bone from elsewhere in the body (usually from the fibula, a small bone from the lower leg). The disadvantage of these reconstruction methods is that they are complex and require vascular anastomosis and also cause morbidity at the donor site. 

When using only metal plates, these can break or extrude through mucosa or skin in about 40% of the cases and the screws with which the plate is attached can come loose. This has dramatic consequences for the patient involved. Our new 3D printed mandible exactly fits the defect, has the shape and weight of the original mandible and is much stronger than the currently used plates.

Functions Such As Talking, Drinking And Eating Are Preserved

The implant is much stronger, partly because the forces are optimally distributed with an improved fastening technique. The implant also has a so-called ‘mesh structure’ on the inside. In this way, the implant retains its strength, while the prosthesis still feels light for the patient (comparable weight of bone is approximated).

The implant can no longer break and the innovative orientation of the fixation screws ensures that the implant stays in place. Because the implant is custom-made, the jaw retains its fit and pressure on the overlying mucosa or skin is distributed more evenly.

We hope this will diminish complications and improve functional and esthetic outcome. Even the tools the surgeon uses in the operation are patient-specific. The operation is also simpler and shorter.

Unique Collaboration

The 3D lab and head and neck surgeons of the Netherlands Cancer Institute have worked for years on this groundbreaking innovation together with the Dutch company Mobius 3D Technologies (M3DT). This application is expected to be more widely applicable in 2023/2024.

In the meantime, research is underway to further expand these techniques for implants elsewhere in the face and skull. Health Holland has made this development possible by granting an innovation grant.

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The post First Successful Operation With Custom 3D-Printed Titanium Lower Jaw appeared first on Asia Pacific Metalworking Equipment News | Manufacturing | Automation | Quality Control.