Revita DMR is an investigational endoscopic hydrothermal ablation device for duodenal mucosal resurfacing proposed for insulin-treated type 2 diabetes.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Tisotumab vedotin is an intravenously administered antibody-drug conjugate targeting tissue factor proposed to treat recurrent or metastatic cervical cancer that has progressed on or following chemotherapy.
The IpsiHand Upper Extremity Rehabilitation System is a brain-computer-interface/robotic arm exoskeleton system for use in chronic stroke patients (≥ 6 months post-stroke) aged ≥ 18 years undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts in a near-physiologic, normothermic, and beating state intended for a potential transplant recipient.
Teplizumab is an intravenously administered anti-CD3 monoclonal antibody in development for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.
Breyanzi (lisocabtagene maraleucel [liso-cel]) is an autologous chimeric antigen receptor (CAR) T-cell therapy, a novel type of immunotherapy in which a patient’s own immune cells are genetically re-programmed to target and attack cancer cells. It is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after 2 or more lines of …
Sutimlimab is an intravenous monoclonal antibody targeting complement component 1s (C1s) for the treatment of cold agglutinin disease.
Sotorasib (AMG 510) is an investigational oral KRAS G12C inhibitor designed to block the abnormal proliferative action of mutant KRAS protein. It is under investigation for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
Oxlumo (lumasiran) is a subcutaneously injected, HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Dosing is weight-based; for children weighing less than 10 kg, the recommended maintenance dose is 3 mg/kg once monthly. Dosing for individua…
The Portable Neuromodulation Stimulator (PoNS) device is a portable neuromodulation stimulator for short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis for use by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.