TECHNOLOGY FOCUS
Medical Devices
A roundup of recent advances in engineering technology. In this issue, a look at breakthroughs and commercialization in the biomedical field.
PATIENT-SPECIFIC ‘PHANTOMS’ TO BE 3D PRINTED
To calibrate imaging technologies such as computed tomography scanners and magnetic resonance imagers, radiologists use what they call “phantoms”—specially designed objects that have specific shapes and radiation-absorbing properties. Some phantoms are as abstract as a container of fluids with different densities, but radiologists also depend on either human volunteers or cadavers, both of which raise ethical concerns as well as the potential for variability due to the uniqueness of every body.
Recently, Stratasys Ltd. and Siemens Healthineers presented the results of research into the use of 3D-printed medical imaging phantoms. According to the companies, they created patient-specific phantoms with realistic radiopacity and anatomical features. These 3D models closely replicated the subsequent images taken of patients.
The companies presented the results at the Radiological Society of North America annual meeting.
In a joint press statement, the companies expressed the hope that by using these kind of 3D-printed phantoms, hospitals and imaging centers could improve the calibration and performance of CT scanners, ensuring more accurate diagnostics and better patient outcomes.
“This is a game-changer for the medical community,” said Erez Ben Zvi, Stratasys’s vice president of healthcare, in a press statement. “We believe this work can speed up the advancement of medicine and improve patient outcomes.”
PARKINSON’S TREATMENT GETS U.S. FDA OK
Parkinson’s disease is a debilitating neurological condition that affects as many as one million Americans. It can result in slowed movements, tremors, balance problems, and other symptoms. While there is no cure, deep brain stimulation has helped manage the symptoms since the 1990s. The treatment involves transmitting electrical signals to the brain via implanted electrodes.
International medical device manufacturer Medtronic received U.S. Food and Drug Administration approval in February 2025 for its new adaptive technology that personalizes deep brain stimulation based on a patient’s brain activity in real time. Existing neurostimulators require the patient to adjust the level of stimulation manually.
“Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson's disease,” said Helen Bronte-Stewart, director of the Human Motor Control and Neuromodulation Lab at Stanford University School of Medicine, in a press statement. “The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”
According to the company, Medtronic has spent 10 years developing the new adaptive system, which it calls BrainSense. The technology can detect, capture, and classify different brain signals. The company said that some 400,000 patients who have a Percept model neurostimulator will be able to use the BrainSense technology.
NEW ANTERIOR CERVICAL CAGE REACHES U.S. MARKET
Patients with deteriorating vertebrae can suffer pinched nerves and severe pain. When those vertebrae are in the neck, the pinched nerves can affect use of the arms. One way to repair this damage is through a transplant of bone tissue between two vertebrae so they fuse together. That process takes about six months, which means the existing bones and the transplant must be relatively immobile during that time.
One way to accomplish that immobility is via a cage that holds the transplant tissue and is secured to the vertebrae via screws. That cage winds up becoming enveloped in new bone growth, so its materials and design are critically important.
Swiss-based medical device company Spineart announced in June that it was launching its anterior cervical cage (designed to be inserted between the cervical vertebrae from the front) in the U.S. market. The cage, called the Scarlet AC-Ti, is composed of porous titanium that is additively manufactured to mimic the structure of natural bone.
The company received 510(k) clearance from the U.S. Food and Drug Administration in May 2024, clearing the way for its non-experimental use in the U.S.
DEVICE PROVIDES FASTER SEPSIS SCREENING
Vail Scientific partnered with Minnetronix to redesign its VSNO sepsis screening device, which is used for sepsis testing and results.
Vail successfully completed proof of concept and feasibility trials for the core technology, which measures sepsis down to single parts per billion. Minnetronix streamlined the device to increase its usability and portability. After a 75 percent reduction in size, the VSNO can now be mounted on an IV pole.
Sepsis is a life-threatening complication from infections that causes organ damage or complete failure. It is the leading cause of death in hospitals and overall cost of hospitalization at an estimated $62 billion. One in three patients who die in a hospital have sepsis, and the disease is particularly serious when not detected and treated early.
Unlike standard sepsis tests, VSNO does not require a blood draw and is planned for use at the triage stage. The streamlined testing process reduces the wait to receive results from approximately eight hours (the time the patient arrives at the hospital to results) to less than two minutes after a patient blows into the device.
“We applied a Design-For-Manufacturing mindset to determine how VSNO can be most efficiently produced and scaled to meet the expected market demand,” said Kera West, engineering director at Minnetronix Medical, in a press statement. “Sepsis hasn’t seen innovation in more than a decade. This is such purpose-driven work, and we can’t wait for the new standard-setting sepsis testing process to be in the market.”
RIDING A BIKE IN AN MRI
Magnetic resonance imagers have been compared to coffins: The patients lay inside a tube with very little room to maneuver. That made a recent paper published in Radiology: Cardiothoracic Imaging all the more remarkable. To test how a patient’s heart reacts to exercise, a research group in the United Kingdom carried out live cardiac imaging on 161 healthy people while they were riding a stationary bike.
The team worked to develop a baseline for Exercise Cardiac MRI (ExCMR), which is used to study the heart’s response to exercise and is a valuable tool for diagnosing and managing various cardiovascular conditions. A special attachment enabled the research subjects to operate a set of pedals mounted on the bench of an MRI scanner while the subjects’ torsos were inside the tube being monitored. As the subjects pedaled, the researchers observed the heart responding to the exercise.
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