Apollo Endosurgery Inc. released details of a landmark, multi-center randomized clinical trial demonstrating the safety and effectiveness of Apollo’s Endoscopic Sleeve Gastroplasty procedure (ESG) performed with the company’s endoscopic suturing system. The Merit study report comes on the heels of FDA market authorization of ESG as a minimally invasive, endoscopic weight loss therapy for patients suffering from obesity.
Rapid Medical Inc. received FDA clearance for the Tigertriever 13, termed “the smallest and only adjustable thrombectomy device” for treating brain clots causing ischemic stroke. Stealing a page from aerospace engineers, Sunrise, Fla.-based Rapid Medical has developed complex, 3D “braiding” technology enabling its mechanical stent retriever to gain better access to and treat deeply embedded brain clots.
Medtronic plc inked an agreement to combine its patient care technologies with a wearable, remote monitoring platform developed by Pasadena, Calif.-based Rockley Photonics Inc. The Bioptx contains compact, photonics-based sensors inside a wristband to monitor a range of biomarkers beyond standard blood pressure, heart rate, pulse oximetry and glucose levels, making Rockley and Medtronic’s development partnership, said Rockley Chair and CEO Andrew Rickman, “a terrific match.”
Spintech MRI Inc. raised $6.5 million in series A financing to expand deployment of MRI software designed to improve and accelerate diagnosis and treatment of Parkinson’s disease, Alzheimer’s and other neurological diseases. The FDA-cleared Strategically Acquired Gradient Echo (Stage) platform is currently in use at more than 50 U.S. hospitals and institutions, including the Yale School of Medicine for advanced research, analysis and treatment of Parkinson’s disease.
The U.S. FDA has cleared the first clinical grade watch for characterizing atrial fibrillation (afib), the most common type of heart arrhythmia in which the heart beats too slowly or irregularly. Developed by Verily, the health tech arm of Alphabet Inc., together with IRhythm Technologies Inc., the Zio Watch will leverage the ability of IRhythm’s Zeus system to diagnose cardiac arrhythmias by combining wearable biosensing with cloud-based data analytics and artificial intelligence.
The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.
Notal Vision Inc. released two clinical reports it said prove the feasibility and efficacy of its patient-operated, home-based optical coherence tomography (OCT) device for monitoring wet age-related macular degeneration (AMD). This comes in the wake of a 2021 report that concluded patient operation of the Notal Vision Home OCT (NVHO) and its machine learning algorithm were generally on par with human experts evaluating retinal fluid and fluid volume in patients with AMD.
The Persona IQ combines a knee implant created by Zimmer Biomet Inc. with sensor technology developed by Canary Medical Inc. to capture performance data on range of motion, walking speed, step count and other orthopedic metrics. Liane Teplitsky, Zimmer Biomet’s president of global robotics likens the Persona IQ to a cardiac pacemaker, in this instance collecting important data on the knee implant so doctors working remotely can better understand how the device is performing post-surgery.
The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.
If GE Healthcare’s GM of Monitoring Solutions Neal Sandy gets his way, nursing staff will perk up and notice a newly launched wireless patient monitoring system that helps them detect patient deterioration much earlier than periodic, manual monitoring.