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.
A MUSCLE-ACTIVATING SLEEVE
Spasticity affects 97 percent of stroke survivors with motor deficits and 84 percent of people with multiple sclerosis. This condition limits movement and causes pain, but a new wearable device from San Francisco-based Cionic offers a way to activate and reeducate muscles with motor stimulation.
The company’s Neural Sleeve 2 received FDA clearance in late 2025. It’s the first FDA-cleared device that can simultaneously activate muscle movement and relax muscle spasms. An app allows users to personalize stimulation and follow guided training with biofeedback, in addition to daily activity and improvement tracking.
AI-driven technology personalizes stimulation patterns to improve walking and assist with daily activities. Home trial participants experienced a 30 percent improvement to spasticity using the Neural Sleeve 2, Cionic reported.
The company designed the wearable device with fuseproject, integrating an advanced technology solution in a bionic-clothing-inspired form factor, comfortable enough for everyday wear.
“Mobility is fundamental to independence, yet for millions of people nationwide the default solutions are wheelchairs, canes, and walkers—devices that haven’t meaningfully changed in centuries,” said Jeremiah Robison, Cionic founder and CEO, in a press statement. "At Cionic, we are building a new operating system for human movement by combining AI, advanced sensing, and stimulation. And we’re moving fast: just two years after the launch of our first sleeve, we’re releasing our second-generation product, which is proof of the speed and rigor we’re bringing to advance this overlooked field.”
>> Photos: Cionic
PULSED ELECTRIC FIELD ABLATION
A relatively common medical treatment is ablation therapy, where doctors will utilize heat, cold, lasers, or even chemicals to destroy abnormal tissues throughout the body.
Redwood City, Calif.-based Galvanize Therapeutics, Inc., announced in May that its new Aliya EX Generator is now FDA approved and is entering a limited commercial release in the United States. The device delivers high-voltage, short-duration electrical energy locally to induce non-thermal regulated cell death.
Doctors will be able to treat a wider range of lesion sizes with the Aliya EX, as it has an ablation diameter that’s twice the size of its predecessors and can ablate as much as seven times more volume.
According to Galvanize, preclinical and clinical studies suggest the device’s process may promote antigen release and immune activation while preserving surrounding tissue architecture.
<< Photo: Galvanize Therapeutics, Inc.
ONLY THE BEST MARGINS
When a patient goes in for a procedure to remove cancerous tissue, they always want to hear that surgeons got clean margins. That will be a bit easier with the help of Perimeter Medical Imaging AI’s Claire, the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment.
Claire combines Perimeter’s proprietary AI with its patented wide-field OCT imaging to enable high-resolution, real-time evaluation of excised tumor margins. The system delivers 10 times higher resolution than standard X-ray and ultrasound at 2 millimeter imaging depth, which is the clinically relevant margin width for breast cancer margin assessment.
In May, Perimeter received FDA premarket approval for Claire along with FDA Breakthrough Device designation. The imaging device is designed to enhance the detection of difficult-to-see cancer during breast-conserving surgery, which would reduce the need for re-operations.
Claire’s AI was trained on a proprietary image library that includes more than 2 million breast tissue images.
Perimeter, which is based in Toronto and Dallas, is currently planning a nationwide launch for Claire.
>> Photo: Perimeter Medical Imaging AI Inc.
FRAGMENTING KIDNEY STONES
One in 10 people experience kidney stones in the United States, making non-invasive solutions to the condition of vital importance. That’s where a device like SonoMotion’s Break Wave lithotripsy device comes in.
Instead of painful catheterization, Break Wave uses low pressure-focused ultrasound to fragment kidney stones by creating standing stress waves within the stone under real-time ultrasound image guidance. The procedure is non-invasive and requires no anesthesia or patient prep restrictions.
The San Mateo, Calif.-based venture-backed medical device company received FDA 510(k) clearance for the device in January.
“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” said Oren Levy, co-founder and CEO of SonoMotion in a press statement. “This 510(k) clearance represents a significant step toward commercialization.”
<< Photo: SonoMotion, Inc.
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