The Flowsense device is a wireless, noninvasive thermal flow sensor in development for the detection of flow in implanted cerebrospinal fluid shunts in patients with hydrocephalus.
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.
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.
Inolimomab (proposed name, Leukotac) is an immunotherapy monoclonal antibody targeting the interleukin-2 receptor (IL-2) in development for the treatment of acute graft versus host disease (aGVHD).
Inclisiran is a subcutaneously administered, investigational RNAi therapeutic that decreases hepatic synthesis of proprotein convertase subtilisin kexin type 9 (PCSK9), leading to increased low-density lipoprotein (LDL) receptor expression on the hepatocyte cell surface and subsequently to greater removal of LDL-C from circulation.
Humacyl is an off-the-shelf bioengineered human acellular vessel proposed for use as a hemodialysis access graft in patients with end stage renal disease (ESRD). This technology uses a process to decellularize donated human vascular smooth muscle cells, while preserving extracellular matrix proteins. This results in a tubular scaffold that is acellular at the time of implanta…
The bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR) implant is a proprietary bio-engineered bridging scaffold made from bovine collagen. It is intended to facilitate healing of a complete ACL tear. It was developed as an alternative to the current standard reconstruction treatment for torn ACLs.
Berotralstat is an oral plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Anifrolumab is an investigational fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.
A radiolabeled monoclonal antibody targeting tumor antigen B7-H3 in development for intraventricular radioimmunotherapy for treatment of neuroblastoma central nervous system/leptomeningeal metastases.
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…