The Organ Care System (OCS) Lung is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation. Commonly referred to as the “lung in a box,” it is a portable device on a removable mobile base that integrates a wireless monitor, perfusion module, ventilator, batteries, gas cyli…
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.
Tymlos (Abaloparatide)
Tymlos is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP) for the treatment of osteoporosis in postmenopausal women who are at increased risk for fracture or have failed or are intolerant to other available osteoporosis therapies. It is self-administered once daily by subcutaneous (SC) injection.
Bevyxxa (Betrixaban)
Bevyxxa is a potent and specific inhibitor of human factor Xa activity that acts by competitively binding to the active site of factor Xa, preventing its ability to convert prothrombin to thrombin. It is the first non-vitamin K antagonist oral anticoagulant (NOAC) approved by the FDA for venous thromboembolism (VTE) prophylaxis in hospitalized acute medically ill adult patients who are at risk…
Nerlynx (Neratinib) for Extended Adjuvant Treatment of Breast Cancer
Nerlynx (neratinib) is an oral tyrosine kinase inhibitor (TKI) recently approved by the FDA for extended adjuvant treatment of early-stage human epidermal growth factor receptor 2 (HER2)–positive breast cancer in patients who have completed standard adjuvant therapy with Herceptin (trastuzumab). Neratinib blocks signal transduction through the epidermal growth factor receptors (EGFR) HER1, HER…
Erleada (Apalutamide)
Erleada is an oral androgen receptor inhibitor approved by the FDA for the treatment of nonmetastatic castration-resistant prostate cancer.
Kymriah (Tisagenlecleucel) for Acute Lymphocytic Leukemia
Kymriah is an autologous chimeric antigen receptor (CAR) T-cell therapy that targets the CD19 surface antigen expressed in aggressive B-cell malignancies. It is produced by adapting the patient’s own immune cells with tumor antigen recognition and T-cell activation domains. The process of producing Kymriah begins with collecting peripheral blood mononuclear cells from the patient via leukapher…
Rydapt (Midostaurin) for Acute Myeloid Leukemia
Rydapt is a twice daily oral FLT3 inhibitor for the treatment of newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Rydapt is also FDA approved for treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with as…
Sentinel Cerebral Protection System (CPS)
The Sentinel Cerebral Protection System (CPS) is a dual filter cerebral embolic protection device indicated for use during transcatheter aortic valve replacement (TAVR). The device contains 2
AquaBeam is a minimally invasive medical device that allows rapid removal of prostate tissue without leaving a zone of thermal damage on the treated tissue. The AquaBeam device combines image guidance and robotics with a high pressure saline jet for targeted and heat-free removal of prostate tissue. It is intended for treatment of lower urinary tract symptoms (LUTS) due to benign prostat… Yescarta (axicabtagene ciloleucel) is an autologous chimeric antigen receptor (CAR) T-cell therapy. It is produced by adapting the patient’s own immune cells to recognize and attack specifically targeted cancer cells. Yescarta is FDA-approved to treat adult patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who have undergone at least 2 previous treatments for their…AquaBeam Aquablation Waterjet Tissue Resection for BPH
Yescarta (Axicabtagene Ciloleucel)