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Insightec wins FDA nod for Exablate Neuro glioblastoma trial
Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma.
The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.
In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain t...
Source: Mass Device - November 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Neurological INSIGHTEC Source Type: news
WakeMed partnership expands new cancer treatment availability
A new partnership between WakeMed Health& Hospitals and Charlotte-based HIFU Prostate Services has expanded the availability of a cancer treatment. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - November 2, 2017 Category: Biotechnology Authors: Jennifer Henderson Source Type: news
SonaCare highlights Medicare payment hike for HIFU
High-intensity focused ultrasound (HIFU) developer SonaCare Medical said that...Read more on AuntMinnie.comRelated Reading:
SonaCare points to new Medicare HIFU reimbursement code
SonaCare debuts international HIFU prostate registry
New HIFU center launches in Ohio
SonaCare, Invivo team up for HIFU ablation tracking
SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 21, 2017 Category: Radiology Source Type: news
Edap submits new FDA 510(k) for Focal One HIFU
Edap (NSDQ:EDAP) said today it submitted a new FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer after withdrawing its previous application in July.
The new application alllowed the France-based company to include a new set of clinical data, which it had decided to include following “advanced discussions” with the FDA earlier this year.
“The new 510k review may be more efficient as the updates only pertain to the clinical section which includes new studies from active and academic Focal One centers in Europe. Our regulatory and c...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Ultrasound EDAP TMS SA Source Type: news
SonaCare Medical Delivers Compatability With bkFusion
CHARLOTTE, N.C., Aug. 30, 2017 -- (Healthcare Sales & Marketing Network) -- SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces today the successful collaboration with BK Ultrasound,... Devices SonaCare Medical, Sonablate, BK Ultrasound, HIFU (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 30, 2017 Category: Pharmaceuticals Source Type: news
Theraclion highlights HIFU research for Graves' disease
Therapeutic ultrasound technology developer Theraclion is pointing to a clinical...Read more on AuntMinnie.comRelated Reading:
Theraclion's Echopulse wins IDE from FDA (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 30, 2017 Category: Radiology Source Type: news
MR-HIFU is kid-safe for osteoid osteoma
MR-guided high-intensity focused ultrasound (MR-HIFU) appears to provide safe,...Read more on AuntMinnie.comRelated Reading:
New trial will assess MR-HIFU, chemo drug combo
DC docs use MR-HIFU to treat bone tumor
FDA approves Philips, Celsion HIFU study (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 25, 2017 Category: Radiology Source Type: news
Profound Medical raises $8m for urology, women ’ s health devices
Profound Medical (TSX:PRN) said today that it inked an $8 million “bought” deal” financing with a pair of underwriters that it plans to use for its Tulsa-Pro and Sonalleve ablation devices.
The funding, by Echelon Wealth Partners and CIBC Capital Markets, involved 10 million units at 80¢ (C$1 ) apiece, consisting of a stock share and a half of a 36-month warrant priced at $1.12 (C$1.40), the Toronto-based company said. The deal also includes a 30-day over-allotment option for another 1.5 million shares, which if exercised would push the gross proceeds to $9.2 million (C$11.5 million).
Profound said it...
Source: Mass Device - August 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Urology Wall Street Beat Women's Health Profound Medical Inc. Source Type: news
Study shows incisionless surgery with MR-HIFU effective in destroying painful bone tumors
(Children's National Health System) Doctors from the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System have completed a clinical trial that demonstrates how osteoid osteoma, a benign but painful bone tumor that commonly occurs in children and young adults, can be safely and successfully treated using an incisionless surgery method called magnetic resonance-guided high-intensity focused ultrasound. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 24, 2017 Category: International Medicine & Public Health Source Type: news
Hybrid modalities disappoint in bone metastases accuracy
Despite the apparent technological advantages of SPECT/CT, PET/CT, and PET/MRI,...Read more on AuntMinnie.comRelated Reading:
ASTRO updates guidelines on painful bone metastases
PET/CT CAD finds common spinal metastases
PET/MRI detects distant metastasis of breast cancer
DC docs use MR-HIFU to treat bone tumor
FDG-PET/MRI shows advantages with malignant bone lesions (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 21, 2017 Category: Radiology Source Type: news
Profound Medical closes $6m Philips Sonalleve MR-HIFU biz buy
Profound Medical (TSX:PRN) said today it closed its $6 million acquisition of Royal Philips (NYSE:PHG) Sonalleve MR-HIFU business
Philips Sonalleve MR-HIFU platform features real-time MR imaging and thermometry alongside high intensity focused ultrasound for incision-free ablation of tissue, Toronto-based Profound Medical said.
“This transaction with Philips is truly transformative for Profound, and represents an opportunity for us to immediately transition from a development-stage to a growth-stage company,. From a commercial perspective, our strengthened MR-Ultrasound ablation technology platform not only benefit...
Source: Mass Device - August 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Mergers & Acquisitions Profound Medical Inc. royalphilips Source Type: news
EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device
Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device.
The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate tissue ablation procedures.
The device features the company’s proprietary fusion algorithm, and is designed to be used with its existing range of HIFU devices.
“As recently mentioned, the next generation of Ablath...
Source: Mass Device - August 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Oncology Regulatory/Compliance EDAP TMS SA Source Type: news
No License: HIFU Prostate Cancer Doc Arrested No License: HIFU Prostate Cancer Doc Arrested
Dr Ronald Wheeler has repeatedly been in the news for his prostate cancer diagnosis and treatment beliefs and methods.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 25, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Philips posts imaging sales gain in Q2
Royal Philips said that its Diagnosis and Treatment segment, which includes...Read more on AuntMinnie.comRelated Reading:
Philips to acquire imaging software firm TomTec
Philips partners on CT dose management initiative
Philips, Varian, IBA partner on Singapore cancer center
Philips to move MR-HIFU business to Profound
Philips buys catheter developer CardioProlific (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 24, 2017 Category: Radiology Source Type: news
Philips to acquire TomTec ’ s imaging software
Royal Philips (NYSE:PHG) said yesterday that it agreed to acquire TomTec Imaging Systems and its intelligent image analysis software for an undisclosed amount.
Munich-based TomTec makes multi-modality and vendor-neutral diagnostic and analysis applications for cardiology, radiology and OB/GYN, the Dutch healthcare conglomerate said. Founded in 1990, TomTec employs more than 100 workers in the U.S., Europe and Asia. Philips said it plans to continue to offer the acquisition’s vendor-neutral product line, integrating its medical software applications into third-party systems.
The deal was expected to close yesterday,...
Source: Mass Device - July 19, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Imaging Mergers & Acquisitions Wall Street Beat royalphilips TomTec Source Type: news