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...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Oncology Pre-Market Approval (PMA) Regulatory/Compliance EDAP TMS SA SonaCare Medical Source Type: news

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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
Source: Annals of Medicine and Surgery - Category: General Medicine Source Type: research
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...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
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.
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
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.
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
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.
Source: WebMD Health - Category: Consumer Health News Source Type: news
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.
Source: Journal of Cancer Survivorship - Category: Cancer & Oncology Source Type: research
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.
Source: Journal of Labelled Compounds and Radiopharmaceuticals - Category: Biochemistry Authors: Tags: RESEARCH ARTICLE Source Type: research
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...
Source: Minerva Urologica e Nefrologica - Category: Urology & Nephrology Tags: Minerva Urol Nefrol Source Type: research
Publication date: Available online 28 May 2020Source: Radiation Physics and ChemistryAuthor(s): Chen Ew-Jun, Tan Teik Hin, Chew Ming Tsuey
Source: Radiation Physics and Chemistry - Category: Physics Source Type: research
Source: The Doctors Lounge - Oncology - Category: Cancer & Oncology Tags: Endocrinology, Nursing, Oncology, Reproductive Medicine, News, Source Type: news
More News: Cancer | Cancer & Oncology | External Beam Therapy | Gastroenterology | Health | Health Management | High Intensity Focused Ultrasound Therapy | Laparoscopy | Medical Devices | Men | Prostate Cancer | Radiation Therapy | Ultrasound | Urology & Nephrology