FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k
SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the U.S. is a milestone for non-invasive prostate care and a tremendous gain for men’s health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There are numerous peer reviewed articles attesting to its value in ablating the prostate while minimizing the occurrence of side effects. Our company is appreciative of the collaborative efforts made on the part of the FDA to bring this technology to the U.S.,” SonaCare CEO Dr.Mark Carol said in a press release. The Sonablate is SonaCare’s 2nd medical device to win clearance, having won 510(k) clearance for its Sonatherm laparoscopic high intensity therapeutic ablation device. “With the authorization to sell Sonablate in the U.S., we can now offer a full HIFU surgical suite of technologies working off of the same basic platform and providing benefits throughout health care centers,” Carol said in prepared remarks. The approval caused therapeutic ultrasound company EDAP to withdraw the de novo application for its Ablatherm device to pi...
Publication date: Available online 30 May 2020Source: Annals of Medicine and SurgeryAuthor(s): Francesco Ziglioli, Marco Baciarello, Giada Maspero, Valentina Bellini, Tommaso Bocchialini, Domenico Cavalieri, Elena Giovanna Bignami, Umberto Maestroni
Abstract Identification and clinical translation of routinely tested biomarkers require a complex and multistep workflow. Here, we described a confirmatory process estimating the utility of previously identified candidate tissue miRNAs for diagnosis of prostate cancer (PCa). RNA was isolated from formalin-fixed paraffin-embedded (FFPE) prostate tissue surgically resected from 44 patients with PCa and 24 patients with benign prostate hyperplasia (BPH). Of the 92 RNA samples obtained, 68 represented 42 malignant (PCa) areas and 26 represented nonmalignant (PCa 0%) areas of the prostate tissue sections. The levels of...
ConclusionsThe increase in a number of genes associated with ribosome biogenesis, translation, and mTOR signaling may be important to evaluate prognosis and determine treatment approach for prostate cancer (PCa). A better understanding of the molecular pathways associated with CSCs may be promising to develop targeted therapies to prolong survival in PCa.
DiscussionThe RCI may be used to aid medical decision making in older Spanish men with PC, especially in those with a high RCI 5 and higher.
For men with advanced prostate cancer, a new hormone therapy pill works better than standard injections -- and carries a much lower risk of heart attack or stroke.
ConclusionsScreening for ADL impairments is needed for older cancer survivors as Katz ADL disability differs by cancer type, stage, and age with greater impairment with advanced age and stage.Implications for cancer survivorsInterventions to address ADL limitations should be considered for older cancer survivors.
ConclusionsWe have successfully synthesized the radiotracer [18F]2 ‐amino‐4‐((2‐((3‐fluorobenzyl)oxy)benzyl)(2‐((3‐(fluoromethyl)benzyl)oxy)benzyl)amino)butanoic acid.In vitro experiments show a good affinity for both the human and rat ASCT ‐2. However, the tracer suffers from poorin vivo tumor uptake in the PC ‐3 model. Briefly, we present the first fluorine‐18 labelled derivative of compound V‐9302, a promising novel ASCT‐2 blocker used for inhibition of tumor growth.
The role of MRI-guided biopsy for diagnosis of prostate cancer; comparison between FUSION and "IN-BORE" approaches. Minerva Urol Nefrol. 2020 May 26;: Authors: D'agostino D, Casablanca C, Mineo Bianchi F, Corsi P, Romagnoli D, Giampaoli M, Fiori C, Schiavina R, Brunocilla E, Artibani W, Porreca A Abstract BACKGROUND: The aim of the present study is to evaluate the difference in terms of feasibility and detection rate of two magnetic resonance imaging (MRI) guided biopsy approaches (MRI fusion versus "in-bore" MRI) in a single tertiary centre. METHODS: We retrospectively identifi...
Publication date: Available online 28 May 2020Source: Radiation Physics and ChemistryAuthor(s): Chen Ew-Jun, Tan Teik Hin, Chew Ming Tsuey