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.

IpsiHand Upper Extremity Rehabilitation System

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.

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Organ Care System (OCS) Heart

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.

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Breyanzi (Lisocabtagene Maraleucel) for Large B-Cell Lymphoma

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 …

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Oxlumo (Lumasiran) for Primary Hyperoxaluria Type 1

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…

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