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.
The Port Delivery System (PDS) with ranibizumab is an investigational intraocular, refillable reservoir implant filled with ranibizumab for the treatment of neovascular age-related macular degeneration.
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…
Ryplazim is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Lumakras (sotorasib) is an oral KRAS G12C inhibitor designed to block the abnormal proliferative action of mutant KRAS protein. It is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who hav…
The Paradise Renal Denervation System uses ultrasound energy delivered via a balloon-cooled catheter to perform targeted circumferential denervation to the renal afferent and efferent sympathetic nerves. The system is proposed for the treatment of hypertension.
Mavacamten is an investigational oral myosin inhibitor that targets the underlying molecular mechanisms of hypertrophic cardiomyopathy (HCM). It is proposed for the treatment of patients with symptomatic obstructive HCM.
The Ventura implant is a transcatheter interatrial shunt for treatment of chronic heart failure with both preserved and reduced ejection fraction.
Bardoxolone is an investigational oral nuclear factor erythroid-derived 2-related factor 2 (Nrf2) activator for the treatment of chronic kidney disease caused by Alport Syndrome.
The Aortix device is a percutaneous mechanical circulatory support device for the treatment of chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure with worsening renal function.
Inclisiran is a subcutaneously administered, investigational RNA interference (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.