MedTech News
.................... by Andrew Celentano
Fziomed Gains FDA De Novo Classification Grant and Marketing Authorization for Oxiplex® Gel in Spine Surgery
Oxiplex is the only FDA authorized intraoperative gel indicated as an adjunct to lumbar spinal surgery to reduce postoperative leg pain and neurological symptoms.
LED-based imaging system could transform cancer detection in endoscopy
Gastrointestinal cancers remain among the most common forms of cancer. While endoscopy has become a cornerstone of cancer screening and diagnosis over the past two decades, the procedure still misses approximately 8% to 11% of tumors, due to visibility limitations. Now, researchers have developed a prototype imaging system that could significantly improve doctors’ ability to detect cancerous tissue during endoscopic procedures.
These ‘exploding’ capsules can deliver insulin without a needle using sodium bicarbonate
Georgia Tech engineers have created a pill that could effectively deliver insulin and other injectable drugs, making medicines for chronic illnesses easier for patients to take, less invasive, and potentially less expensive.
AI used to improve speed and accuracy of autism and ADHD diagnoses
It can take as long as 18 months for children with suspected autism spectrum or attention-deficit-hyperactivity disorders to get a diagnostic appointment with a psychiatrist in Indiana. But an interdisciplinary team led by an Indiana University researcher has developed a new diagnostic approach using artificial intelligence that could speed up and improve the detection of neurodivergent disorders.
Liquid biopsy test uses RNA modifications to detect early-stage colorectal cancer with 95% accuracy
Liquid biopsies are tests that detect signs of cancer through a simple blood draw. Unlike traditional biopsies, which require removing a piece of tissue, a liquid biopsy typically looks for mutations or modification changes in fragments of DNA from cancer cells circulating in the blood.
Implantable glucose monitor competitor emerges with early data
Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.
Morphic Medical Secures CE Mark for RESET® Endoscopic Therapy Device
Regulatory milestone paves the way for expanded access to Morphic’s non-implant, incisionless solution for treating acid reflux and related gastrointestinal disorders across Europe.
Mendaera wins FDA clearance for robotic needle placement
Mendaera has received FDA 510(k) clearance for its Focalist handheld robotic system, which enhances the precision of ultrasound-guided needle placement across multiple specialties.