High-intensity focused ultrasound

GEORGIA HOSPITAL IS THE FIRST AND ONLY IN STATE TO OFFER NON-INVASIVE LIVER CANCER TREATMENT

Retrieved on: 
Thursday, March 14, 2024
Liver, Patient, Neoplasm, Tissue, MD, Needle, High-intensity focused ultrasound, FDA, Physician, Medical imaging

GAINESVILLE, Ga., March 14, 2024 /PRNewswire/ -- Patients in the southeast now have an innovative, non-invasive treatment option for liver cancer tumors.

Key Points: 
  • GAINESVILLE, Ga., March 14, 2024 /PRNewswire/ -- Patients in the southeast now have an innovative, non-invasive treatment option for liver cancer tumors.
  • In a groundbreaking leap forward, Northeast Georgia Medical Center (NGMC) has become the only hospital in Georgia – and one of the few in the United States – to offer a new, progressive form of cancer treatment known as histotripsy.
  • "Histotripsy represents the latest advancement in cancer care, using soundwaves – not surgery – to eliminate cancerous tissue," said Nelson Royall, MD, a surgeon with Northeast Georgia Health System's employed physicians group, Northeast Georgia Physicians Group.
  • This includes tumors that have formed within the liver or those that have spread to the liver from other organs.

INSIGHTEC FOCUSED ULTRASOUND NOW COVERED FOR PARKINSON'S DISEASE PALLIDOTOMY IN US

Retrieved on: 
Monday, February 26, 2024
Quality of life, High-intensity focused ultrasound, Blue Shield, DSM-IV codes, Hope, Tremor, Elevance Health, Safety, Parkinson's disease, Anesthesia, BCBS, Neuro, Insurance, Health insurance

HAIFA, Israel and MIAMI, Feb. 26, 2024 /PRNewswire/ -- Anthem Blue Cross and Blue Shield (BCBS) has become the first insurance provider to extend coverage for the innovative focused ultrasound pallidotomy procedure as part of their comprehensive Parkinson's disease treatment coverage. This decision brings hope and relief to more than 1 million Americans living with Parkinson's who now have greater access to an incisionless treatment alternative, when medications have been unsuccessful or have resulted in intolerable side effects.

Key Points: 
  • Insightec, a global leader in focused ultrasound, developed the pioneering treatment that uses MR-guided focused ultrasound (MRgFUS) to destroy a small area of brain tissue involved in the motor symptoms of Parkinson's.
  • "Parkinson's disease is the second-most common neurodegenerative disorder in the US, affecting as many as 1 million Americans," continues Dee Kolanek, VP of Market Access and Reimbursement for Insightec.
  • "By offering coverage reimbursement for focused ultrasound pallidotomy, Anthem BCBS is demonstrating its leadership in the industry, as well as their commitment to the well-being of their members and a significant patient population."
  • For additional information about Anthem Blue Cross and Blue Shield and the specific qualifications of coverage for the Insightec focused ultrasound thalamotomy procedure, please contact their member services or visit their official website .

HistoSonics Notches Significant Reimbursement Wins

Retrieved on: 
Monday, November 6, 2023
Radiology, Research, Insurance, Oncology, Software, Medical Devices, Hardware, Hospitals, Professional Services, Science, Technology, Clinical Trials, FDA, Biotechnology, Surgery, Health, Health Technology, Health Insurance, Liver, Sale, Medicare, Government, Diagnosis-related group, Physician, High-intensity focused ultrasound, American Medical Association, Infection, Kidney, Bleeding, Blue, Ambulatory Payment Classification, Multimedia, IDE, AMA, Tissue, APC, Diagnosis, Hospital, Centers for Medicare & Medicaid Services, CPT, Pain, Patient, Investigational New Drug, DRG, CMS, Medical imaging, Medicaid

We commend CMS on facilitating access to breakthrough devices like ours for Medicare patients, many of whom historically have had delayed access to innovative technology,” commented HistoSonics President and CEO Mike Blue.

Key Points: 
  • We commend CMS on facilitating access to breakthrough devices like ours for Medicare patients, many of whom historically have had delayed access to innovative technology,” commented HistoSonics President and CEO Mike Blue.
  • HistoSonics’ Edison Histotripsy System combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels.
  • Additionally, the American Medical Association (AMA) has recently issued a new Category III CPT code for histotripsy of kidney tissue.
  • The release of this new code represents a major reimbursement milestone as hospitals across the US will be able to submit claims directly related to the service.

INSIGHTEC ANNOUNCES NEW CATEGORY I CPT® CODE FROM AMA FOR NEURO PROCEDURES USING MR-GUIDED FOCUSED ULTRASOUND

Retrieved on: 
Thursday, November 2, 2023
FDA, Cat, Essential tremor, Tremor, Parkinson's disease, American Association of Neurological Surgeons, Neuro, Physician, American Medical Association, Congress, MD, CNS, Health, High-intensity focused ultrasound, AMA, AANS, Congress of Neurological Surgeons, DSM-IV codes, Patient, Medical imaging, Medical device, Insightec

HAIFA, Israel and MIAMI, Nov. 2, 2023 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that the editorial panel of the American Medical Association (AMA) approved their application to establish a new Category (Cat) I Current Procedural Terminology (CPT®) code to facilitate reimbursement for MR-guided focused ultrasound (MRgFUS) ablation of neurological targets. The Cat I CPT® code will be included in the next CPT® codebook and expected to be effective January 1, 2025.

Key Points: 
  • The Cat I CPT® code will be included in the next CPT® codebook and expected to be effective January 1, 2025.
  • "We've long known that focused ultrasound has a significant and valuable role in treating patients with neurological disorders.
  • "This approval can also lead to expanded access to focused ultrasound for US patients," says Dee Kolanek, vice president of market access and reimbursement for Insightec.
  • Focused ultrasound, which was pioneered by Insightec, is FDA approved to treat essential tremor and Parkinsonian tremor.

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Retrieved on: 
Monday, October 9, 2023
Surgery, Medical Devices, FDA, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Oncology, Congress, Infection, Food, Hepatocellular carcinoma, Blue, Breast, Rectum, Liver disease, Liver, Radiation, Safety, University, CTCAE, Patient, Education, High-intensity focused ultrasound, Thomas Edison, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Amaral, Colon, Science, Neoplasm, Needle, HCC, Physician, Medical imaging

Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

Key Points: 
  • Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.
  • View the full release here: https://www.businesswire.com/news/home/20231009669222/en/
    HistoSonics Edison Histotripsy System (Photo: Business Wire)
    FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.
  • HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control.
  • The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

EDAP Announces Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 24, 2023
Operating cost, University of Zurich, Assistant professor, CMS, University, AUC, Prostate cancer, TMS, Marketing, AUA, Medicines and Healthcare products Regulatory Agency, EDAP, League, American Urological Association, Woman, DACH, League of European Research Universities, USC, EDT, USD, Hospital, MD, Urology, Patient, Investment, Annual general meeting, High-intensity focused ultrasound, Growth, Lithotripsy, Conference, Cryptocurrency, Video game, Medical imaging, Pharmaceutical industry, Film industry, Lithium, EUR, Distribution

We are also pleased with strong U.S. Focal One HIFU procedure growth, which grew 85% during the second quarter of 2023 versus the second quarter of 2022.

Key Points: 
  • We are also pleased with strong U.S. Focal One HIFU procedure growth, which grew 85% during the second quarter of 2023 versus the second quarter of 2022.
  • The increase was driven by four Focal One units sold in the second quarter 2023 versus one unit sold in the second quarter of 2022.
  • Operating loss for the second quarter of 2023 was EUR 4.2 million (USD 4.6 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2022.
  • A conference call and webcast to discuss second quarter 2023 financial results will be hosted Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today, Thursday, August 24th, 2023 at 8:30am EDT.

Focused Ultrasound Treatment is Proven an Effective Treatment to Curb Tremor for at Least Five Years

Retrieved on: 
Thursday, July 20, 2023
Essential tremor, Tremor, Life, International Classification of Functioning, Disability and Health, FUS, Medicine, Clinical trial, Quality of life, CRST, Trial of the century, High-intensity focused ultrasound, ET, MD, Patient, The New England Journal of Medicine, FDA, Health, Journal of Neurosurgery, Safety, QUEST, Pharmaceutical industry, Medical imaging, Insightec, Neurosurgery

HAIFA, Israel and MIAMI, July 20, 2023 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using focused ultrasound (FUS) technology to transform patient care, today announced FDA approval of the five-year study endpoint for the largest prospective long-term, follow-up study of unilateral MR-guided focused ultrasound (MRgFUS) surgery (thalamotomy) for essential tremor (ET) to date. The data shows sustained and significant tremor improvement at five years with an overall improvement in quality-of-life measures and without any progressive or delayed complications. The study also confirms the long-term efficacy of the procedure for sufferers of ET, and follows the recent FDA approval of use of the technology to treat the second side tremor of appropriate patients. Insightec's Focused Ultrasound technology has been used to perform over 11,000 procedures worldwide.

Key Points: 
  • Insightec's Focused Ultrasound technology has been used to perform over 11,000 procedures worldwide.
  • "It also substantiates that using MR-guided focused ultrasound to treat essential tremor is safe and effective, as well as long-lasting.
  • We look forward to making further progress in finding more uses for focused ultrasound and building on the success of the treatment of essential tremor."
  • "Being part of the clinical study 7 years ago was life changing," says Alexandra Lebenthal, a clinical trial Focused Ultrasound patient from 2016.

Hoag Introduces New Precision Treatment for Prostate Cancer Patients

Retrieved on: 
Tuesday, June 27, 2023
High, Biopsy, Prostate cancer, High-intensity focused ultrasound, Molecular imaging, PSMA, Quality of life, Prostate, MRI, Radiation, Magnetic resonance imaging, Mastectomy, Patient, Physician, Risk, Surgeon, Diagnosis, Neoplasm, Breast cancer, Disease, Medical imaging, Dairy, Medical device

The result is a cancer treatment without many of the side effects that come with treating the entire prostate, including urinary and erectile side effects.

Key Points: 
  • The result is a cancer treatment without many of the side effects that come with treating the entire prostate, including urinary and erectile side effects.
  • "Analogous to a woman choosing a lumpectomy for her breast cancer, not all men with localized prostate cancer want or need the entirety of their prostate treated," said Hoag urologic oncologist Daniel Su, M.D.
  • Hoag was the first hospital in Orange County to offer prostate specific membrane antigen (PSMA)-targeted radiotherapy for metastatic prostate cancer, as part of Hoag's Molecular Imaging & Therapy program.
  • And now, Hoag is proud to offer a new treatment option for men with localized prostate cancer.

Brain Cancer Canada Matches Community Fundraising to Support Groundbreaking DIPG Research

Retrieved on: 
Wednesday, May 17, 2023
Hospital for Sick Children, Survivor, Therapy, Friends, Parent, Rafal E. Dunin-Borkowski, Clinical trial, Hope, Traffic barrier, Research, High-intensity focused ultrasound, Borkowski, Patient, The Hospital, BCC, Partnership, Brain, Diffuse intrinsic pontine glioma, Caregiver, Medical imaging, DIPG

Dr. Rutka’s research project targets childhood Diffuse Intrinsic Pontine Glioma (DIPG), a highly aggressive tumour that currently has no effective treatments.

Key Points: 
  • Dr. Rutka’s research project targets childhood Diffuse Intrinsic Pontine Glioma (DIPG), a highly aggressive tumour that currently has no effective treatments.
  • The grant starts with an incredible $50,000 raised by the tireless DIPG community, an amount matched by BCC to support this critical research further.
  • "From a broader perspective, DIPG also has one of the highest societal burdens of any disease.”
    Dr. Rutka's early-stage research proposes a novel approach to addressing DIPG.
  • This research grant embodies the tenacity and hope of the DIPG community.

SonALAsense Welcomes Dr. Ely Benaim as Chief Medical Officer and Executive Vice President of Development

Retrieved on: 
Tuesday, May 9, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Data management, Amgen, Drug development, Diffuse intrinsic pontine glioma, Jude the Apostle, History, Doctor of Philosophy, Glioblastoma, High-intensity focused ultrasound, DIPG, Journal, Patient, ALA, Reactive oxygen species, Takeda Oncology, Journal of Neuro-Oncology, Decompression (diving), Sonodynamic therapy, Aminolevulinic acid, FDA, SDT, Safety, Medical imaging, Nursing, Pharmaceutical industry, Medical device, Development

SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development.

Key Points: 
  • SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development.
  • Benaim brings decades of clinical and industry experience and incredible insights to SonALAsense,” said Mark de Souza, PhD, Chief Executive Officer at SonALAsense.
  • Later, he moved into drug development, taking high-profile positions at Amgen, Sangamo BioSciences, Millennium Pharmaceuticals, Rexahn Pharmaceuticals and others.
  • Prior to joining SonALAsense, he was Chief Medical Officer for Novocure, where he managed several pivotal clinical trials.