Engineers at Atlanta-based Georgia Tech’s Center for 3D Medical Fabrication have developed a 3D-printed tracheal splint as an airway for children born with a rare condition known as tracheal agenesis or the absence of a trachea or windpipe.

Paragonix Technologies Inc. will soon release performance data from sterile, temperature-controlled systems for transporting donor organs to recipient patients, this after a breath-taking transport last year of a donor lung and heart from Alaska to Washington and North Carolina. Paragonix’s organ preservation technology provides thermal protection for donor organs for up to 40 hours, making them ideal for transportation over long distances, said the company.

The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.

Inspan LLC has won FDA 510(k) clearance for an interspinous fixation system that can now be used to treat lumbar spinal stenosis in non-cervical spine cases of spondylolisthesis, trauma, tumor and degenerative disc disease. According to Aditya Humad, co-founder and CFO of Kicventures Group which counts Inspan among its portfolio companies, FDA clearance represents an expansion in the use of Inspan’s interspinous system into the “highly competitive space” of interventional pain management.

TORONTO – Hyivy Health Inc. has secured CA$1.1 million (US$888,000) in pre-seed funding to manufacture, test and obtain medical device approval for a women’s pelvic rehabilitation platform and to explore its use for relieving pelvic pain during clinical trials this summer.

That excruciating moment when patients learn their lives are potentially at risk to a “wide neck” brain aneurysm could be softened by results of a long-awaited international study led by researchers at Massachusetts General Hospital (MGH) and Harvard Medical School. According to lead author Adam Dmytriw, wide-neck aneurysms will respond better to the Woven Endobridge Web device than metal stents and blood thinners.

University of California San Diego engineers have developed tiny 2D sensors that pop up to become a 3D assemblage of microscopic sensors for directly measuring the movement and speed of electrical signals inside the heart. According to nanoengineering professor Sheng Xu, the nanotechnology has enormous implications for heart doctors anxious to better diagnose and treat arrhythmia, heart attack and other diseases.

Bioventus Inc. has received FDA 510(k) clearance for a device that enables surgeons to remove bone in hard-to-work spaces during minimally invasive surgery. It acquired the company that developed the tool, Great Neck, N.Y.-based Misonix Inc., in October.

TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada.

TORONTO – Cloud Dx Inc. has entered into an exclusive corporate agreement with Medtronic Canada ULC to provide the subsidiary of Medtronic plc virtual and remote patient monitoring (RPM) technology and services across Canada. Medtronic Canada will begin by integrating Cloud Dx’s Connected Health platform along the perioperative and complex chronic disease pathways that make up the country’s health care network.