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Philips to acquire imaging software firm TomTec
Royal Philips has signed an agreement to acquire German imaging software developer...Read more on AuntMinnie.comRelated Reading: Philips partners on CT dose management initiative Philips, Varian, IBA partner on Singapore cancer center Philips to move MR-HIFU business to Profound TomTec nets FDA OK for new software TomTec launches cardiac visualization software at ACC TomTec launches online teaching tool (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 18, 2017 Category: Radiology Source Type: news

EDAP pulls FDA bid for Focal One, plans to resubmit with new data
Edap (NSDQ:EDAP) said today it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data. “As mentioned during our last quarterly call, a shift in biopsy protocol has created difficulties in comparing biopsy data under the current 510k application. We actively worked with some of our key users in Europe to gather new and additional clinical data on Focal One in...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Oncology Regulatory/Compliance Ultrasound EDAP TMS SA Source Type: news

Philips partners on CT dose management initiative
Royal Philips and West Physics are collaborating to create a CT radiation dose...Read more on AuntMinnie.comRelated Reading: Philips, Varian, IBA partner on Singapore cancer center Philips to move MR-HIFU business to Profound Philips buys catheter developer CardioProlific Philips to buy Spectranetics in $2.2B deal Philips lands FDA nod for new IntelliSpace applications (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 17, 2017 Category: Radiology Source Type: news

Philips, Varian, IBA partner on Singapore cancer center
Royal Philips plans to collaborate with Varian Medical Systems and Ion Beam...Read more on AuntMinnie.comRelated Reading: Philips to move MR-HIFU business to Profound IBA inks Va. installation deal Philips buys catheter developer CardioProlific FDA clears Varian's Halcyon rad therapy system IBA to show updated synthesizer at SNMMI 2017 Varian to build radiation oncology centers in Vietnam (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 12, 2017 Category: Radiology Source Type: news

Philips to move MR-HIFU business to Profound
Royal Philips has made an agreement to transfer its MR-guided high-intensity...Read more on AuntMinnie.comRelated Reading: Philips buys catheter developer CardioProlific Philips to buy Spectranetics in $2.2B deal Philips lands FDA nod for new IntelliSpace applications Philips relaunches Pioneer Plus IVUS catheter Philips launches new business intelligence software (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 6, 2017 Category: Radiology Source Type: news

Philips picks up peripheral thrombectomy device maker CardioProlific
Royal Philips (NYSE:PHG) last week said it paid an unspecified amount to acquire stealthy CardioProlific and the peripheral thrombectomy catheters it’s developing. Philips said the deal for Hayward, Calif.-based CardioProlific is complementary to its $2.16 billion acquisition of Spectranetics (NSDQ:SPNC) and its own line of image-guided therapies. “The acquisition of CardioProlific will further strengthen our innovation pipeline of catheter-based therapy devices,” image-guided therapy business leader Bert van Meurs said in prepared remarks. “We are convinced that the development of CardioProlific&...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Mergers & Acquisitions cardioprolific peripheral royalphilips Source Type: news

Profound Medical to pay $6m for Philips ’ Sonalleve MR-HIFU biz
Profound Medical (TSX:PRN) said today that it agreed to put up about $6 million worth of its own shares to acquire the Sonalleve MR-HIFU business from Royal Philips (NYSE:PHG). Toronto-based Profound said the deal calls for it to put up 7.4 million shares at 84.9¢ (C$1.10) apiece, representing a 22% premium over its closing price yesterday. The total deal value is $6.3 million (C$8.1 million) The agreement also has earn-outs pegged to future revenues of 5% to 7% of Sonnalleve sales through 2020, the company said. Philips, which already sells Profound’s Tulsa-Pro prostate ablation system, also pledged to distribute...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Imaging Mergers & Acquisitions Wall Street Beat Women's Health Profound Medical Inc. royalphilips Source Type: news

Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial
Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French company said. Theraclion is hopeful that HIFU treatment may locally potentiate immune responses induced by the immunotherapy drugs. Read the whole story at our sister site, Drug Delivery Business The post Theraclion partner UVA wins FDA nod ...
Source: Mass Device - June 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Theraclion Source Type: news

Echotherapy: A Future Option for Benign Thyroid Nodule Symptoms? Echotherapy: A Future Option for Benign Thyroid Nodule Symptoms?
High-intensity focused ultrasound ablation, or echotherapy, of symptomatic but benign solid thyroid nodules is an emerging technology, available in a few clinics in Europe.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 7, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Theraclion touts Echopulse data from thyroid nodules studies
Theraclion (EPA:ALTHE) touted data today from 3 studies evaluating the use of Echopulse as a non-invasive treatment for benign thyroid nodules. One of the studies was the 1st direct comparison of echotherapy to surgery. The study, which was published in the International Journal of Hyperthermia, compared 43 patients who were treated with Theraclion’s Echopulse, an ultrasound-guided high-intensity focused ultrasound system, to 103 patients who underwent hemithyroidectomy. Patients who were treated with the French company’s system experienced significantly lower incidence of subclinical hypothyroidism, better...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Surgical Ultrasound Theraclion Source Type: news

SonaCare points to new Medicare HIFU reimbursement code
High-intensity focused ultrasound (HIFU) developer SonaCare Medical said the...Read more on AuntMinnie.comRelated Reading: 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 SonaCare teams up with Invivo (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - May 23, 2017 Category: Radiology Source Type: news

EDAP touts CMS reimbursement win for HIFU prostate ablation
Edap (NSDQ:EDAP) today touted that the Centers for Medicare & Medicaid Services established reimbursement billing codes for high intensity focused ultrasound ablation procedures for prostate tissue. The French company said that the new CMS C-code covering HIFU ablation of prostate tissue procedures will take effect July 1. The code will cover procedures performed by its HIFU devices, including whole primary gland prostate ablation, partial prostate ablation or whole and partial salvage ablation. “We are elated by CMS’s decision. This is another key milestone in the acceptance and recognition of HIFU techno...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Ultrasound EDAP TMS SA Source Type: news

Insightec wins FDA nod for Exablate Neuro for use with 1.5T MRI
Insightec said today it won FDA approval for its Exablate Neuro model 4000 system, now cleared for use with 1.5 Tesla magnetic resonance imaging for treating essential tumor in patients non-responsive to medication. The Exablate Neuro device 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. “Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option us...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance InSightec Ltd Source Type: news

Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial
Insightec today announced that the 1st patient has been treated in a feasibility trial exploring the use of its Exablate Neuro system for treating benign centrally-located intracranial tumors in pediatric and young adults. The Exablate Neuro device 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. A team at the Nicklaus Children’s Hospital performed the 1st procedure on a 21-year old patient suffering from seizures associated with a benign hypothalamic hamartoma brain tu...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological InSightec Ltd Source Type: news

SonaCare debuts international HIFU prostate registry
High-intensity focused ultrasound (HIFU) technology developer SonaCare Medical...Read more on AuntMinnie.comRelated Reading: New HIFU center launches in Ohio SonaCare, Invivo team up for HIFU ablation tracking HIFU Prostate opens up Ohio treatment center HIFU Prostate Services signs Texas client SonaCare lands FDA nod for HIFU system (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 11, 2017 Category: Radiology Source Type: news