U-Systems’ breast cancer tool wins FDA panel nod

U-Systems logo

The FDA’s radiological device panel voted to recommend U-Systems‘ Somo•v automated breast ultrasound system for pre-market approval as a breast cancer screening tool.

If approved, Somo•v would be the only ABUS system in the U.S. indicated for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.

Dense tissue in the breasts may pose an increased risk of cancer and represents a challenge for traditional mammography, according to a press release.

"The potential of 3D ABUS in a screening environment is to find these 30% additional cancers that would not have been found with what is now the standard of care," Dr. Rachel Brem, director of breast imaging at George Washington University Hospital, said in prepared remarks. "Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone."

The Somo•v system already has FDA clearance for diagnostic use alongside mammography and won CE Mark approval for breast cancer screening in the European Union in September 2010.

The approval was based on clinical results from the the Somo.Insight study, U-Systems claims to be the largest-ever clinical study by an ultrasound company. It was designed to evaluate whether digital mammography used with the Somo•v system was more sensitive than routine mammography alone in detecting breast cancer in women with greater than 50% dense breast tissue.

"We are very excited the FDA Panel recommended approval of a breast cancer screening indication for the Somo•v ABUS system," president & CEO Ron Ho said in prepared remarks. "If the FDA approves the Somo•v PMA, this important adjunctive screening tool for women with dense breasts has the opportunity to become widely available in clinical practice. This is vitally important, because at least 40% of women in the United Stated have dense breast tissue."

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Comments

  1. says

    I just want to tell you that I am just very new to blogging and absolutely savored your web page. Most likely I’m planning to bookmark your website . You really have impressive posts. Thanks a bunch for revealing your website page.

  2. says

    I just want to say I’m all new to weblog and honestly liked you’re blog. More than likely I’m planning to bookmark your blog post . You certainly have really good well written articles. Thanks a bunch for sharing your blog site.

  3. says

    I simply want to say I am new to blogging and really liked you’re web blog. Very likely I’m planning to bookmark your blog post . You actually come with fantastic well written articles. Thanks a bunch for revealing your blog.

  4. says

    I just want to say I’m all new to blogs and truly liked your blog. Almost certainly I’m want to bookmark your website . You definitely have superb articles and reviews. Thanks a lot for sharing your blog.

Trackbacks

  1. Nice article

    Apakah kamu membutuhkan obat herbal de Nature Indonesia silahkan dapat hubungi customer service kita secara langsung melalui SMS ataupun Telepon. Kami selalu online 24 jam utk melayani pembelian obat herbal de Nature.

  2. Informative content

    Apakah agan membutuhkan obat herbal de Nature Indonesia silahkan bisa hubungi customer service kami secara langsung via SMS ataupun Telepon. Kami selalu online 24 jam untuk melayani pemesanan produk herbal de Nature.

Leave a Reply