RBX2660 is a microbiota-based investigational product for fecal microbiota transplantation proposed to treat recurrent Clostridium difficile infection. It is derived from fresh stool from multiple donors; both donors and stool samples are methodically screened. Pooled stool samples are commercially prepared under good manufacturing processes. RB…
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.
Eversense Continuous Glucose Monitor
The Eversense CGM is a continuous glucose monitor with implantable sensor for measuring glucose levels continually for up to 90 days in adults aged 18 years and older with either type 1 or type 2 diabetes. The Eversense CGM System consists of 3 components: an implantable cylindrical glucose sensor, a wearable smart transmitter, and a handheld device running a mobile medical application. The tr…
Inspiris Resilia Aortic Valve
The Inspiris Resilia is a replacement aortic valve comprised of 3 elements: Resilia tissue, VFit technology, and Carpentier-Edwards Perimount Magna Ease valve design. Carpentier-Edwards is an established, proven valve design; VFit is a new, proprietary platform that is designed for future adaptation for valve-in-valve procedures. Resilia tissue is a new, first-of-its-kind tissue platform that …
Olumiant (Baricitinib)
Baricitinib is a once daily, oral selective Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonist therapies. JAK inhibitors are small molecules that interrupt intracellular signaling pathways in the inflammatory cycle by inhibiting the activ…
Senhance Surgery System for Robotic Surgery
The Senhance Surgery System (formerly Telelap ALF-X) is a robotic surgery platform intended for use in laparoscopic surgery. The Senhance system is the first robotic system that brings haptic force feedback to robotic surgery. This feature enables the surgeon to feel the level of force applied during delicate tasks and is proposed to lead to improved safety and allow certain maneuvers to be pe…
Xeljanz (Tofacitinib) for Ulcerative Colitis
Xeljanz is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). Xeljanz is the first oral therapy to be FDA-approved for the treatment of moderately to severely active UC.
Aimovig (Erenumab)
Aimovig is a novel monoclonal antibody targeted to calcitonin gene-related peptide (CGRP) for migraine prevention. CGRP is involved in vasodilation and sensory transmission, and is a validated target that is believed to play a key role in migraine headache. Aimovig targets the CGRP receptor; this mechanism differentiates it from other investigational anti-CGRP antibodies, which bind to the lig…
Kymriah (Tisagenlecleucel) for Diffuse Large B-Cell Lymphoma
Kymriah (tisagenlecleucel, formerly CTL019) is an autologous CAR T-cell therapy, a novel type of immunotherapy in which a patient’s own genetically altered immune cells are used to attack cancer cells. The FDA approved Kymriah in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. I…
AngelMed Guardian System
The AngelMed Guardian System is a single-lead, implantable cardiac device designed to detect acute ischemic events and to prompt the patient to seek medical attention for a potential acute coronary syndrome (ACS) event. The FDA approved this device in April 2018 for use an adjunct to patient-recognized symptoms predictive of ACS in patients who have had prior acute ACS events and who remain at…
Ribaxamase (SYN-004)
Ribaxamase is an investigational oral recombinant beta lactamase enzyme that binds with and degrades intravenous (IV) beta-lactam antibiotics that are excreted into the intestines, thus potentially protecting the gut from opportunistic enteric infections without compromising antibiotic therapy. It is proposed for co-administration with certain intravenous beta-lactam antibiotics to prevent …