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シグノスティックス、ブラッダーケアのための超音波画像診断デバイス、「Uscan™」の日本市場への本格的導入と販売へ

2016年8月5日

株式会社シグノスティックス・ジャパン(本社:東京都、日本法人代表取締役社長 北川 貴綱)は、ブラッダーケア用超音波画像診断デバイス、Uscan™について日本国内での販売を開始したことをお知らせいたします。

Uscan™は、膀胱内尿量を正確に自動計測できるブラッダーケア用の超音波画像診断デバイスです。また、Uscan™は、ウロロジカル・カテーテル留置・挿入の確認や、腎臓、骨盤底など臓器や組織の Point-of-Care 超音波画像を迅速かつ簡単に提供することができるイメージングツールとしての機能も持ち合わせた製品です。さらには、高解像度のタッチスクリーンディスプレイおよび着脱可能なプローブ付きタブレット型デバイスであるため、簡易にどこにでも持ち運びができ、泌尿器科領域にとどまらず、救急、婦人科、小児科、オンコロジー、リハビリテーション、高齢者ケア、および在宅介護等、あらゆる臨床現場において、広く患者様の治療管理に寄与していくことが期待されます。

株式会社シグノスティックス・ジャパン 日本法人代表取締役社長の北川貴綱は、次のように述べています。「Uscan™は、コンピュータービジョン・アルゴリズムにより、単なるスキャンではなく、超音波画像を描出しながら、より精度の高い尿量の数値化を実現しました。また操作性をシンプルかつ簡単にすることにより、従来の大型超音波デバイスでの複雑な計測などによる時間やコストを削減し、ブラッダーケアに広くご利用いただけます。」

Uscan™は、5 年保証付、定期キャリブレーションが不要で、従来の膀胱スキャナに不可欠なメンテナンス費用の削減を実現しました。また、シンプルな操作性に加えユーザーガイダンスがリアルタイムで画面上に表示されるので、どなたでも容易に使用方法を習得することができます。

製品概要
販売名:Uscan シリーズ
一般的名称:汎用超音波画像診断装置(JMDN: 407061000)
医療機器のクラス:管理医療機器、特定保守管理医療機器
医療機器認証番号:228APBZI00001000
外国特例認証取得者:Signostics Limited
日本総販売元:株式会社シグノスティックス・ジャパン(Signostics Japan K.K.)
選任製造販売業者:有限会社ユーマンネットワーク
認証日:2016年8月1日

Uscan™について
Uscan™はブラッダーケアとしての超音波画像診断デバイスです。Uscan™はコンピュータービジョン・アルゴリズムを使い膀胱輪郭を 3D でとらえ、最大 256 枚(従来機器の 32 倍)の膀胱断面を取得することにより、患者の体型・年齢に関係なく、高精度で膀胱内尿量を自動計測します(*)。また、迅速かつ簡単なイメージング
ツールとして、腎臓、骨盤底、前立腺、膀胱結石、およびカテーテル留置の超音波画像を提供します。
Uscan™は、Android オペレーティングシステム搭載、Wi-Fi、Bluetooth 接続機能を持ち、高速で信頼性の高 い画像管理が可能です。また、このクラスでは初のミドルウェアを内蔵しました。
(*)ファントムを使用したテストによる結果

(医療機器承認番号:228APBZI00001000)

シグノスティックスについて
Signostics Inc.はグローバルな医療機器メーカーである Signostics Limited の完全子会社です。KKR のポートフォリオ企業であるシグノスティックスは、泌尿器科領域での画像診断と臨床判断の水準を高める超音波画像診断デバイスのパイオニアです。主力製品の Uscan™は、コンピュータービジョン・アルゴリズムを通じて、超音波画像を描出するブラッダーケアのためのデバイスです。シグノスティックスの製品は米国、オース
トラリア、カナダ、欧州、シンガポール、および日本で許認可を取得し、世界各国でご利用いただいています。シグノスティックスについては www.signosticsmedical.com をご覧ください。

株式会社シグノスティックス・ジャパン(Signostics Japan K.K.)について
株式会社シグノスティックス・ジャパンは、シグノスティックスの日本法人です。日本においては、2016 年 3 月より事業を開始し、ブラッダーケアのための超音波画像診断デバイスのパイオニアとして、Uscan™を多くの臨床現場へお届けすることを通じて、医療に貢献していくことを目指しています。シグノスティックス・ジャパンについては、jp.signosticsmedical.com をご覧ください。

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【本プレスリリースに関するお問い合わせ先】
株式会社シグノスティックス・ジャパン 広報代理 エデルマン・ジャパン株式会社 山田、正木
TEL: 03-4360-9000 / Email: SignosticsJapanPR@edelman.com

Improving Imaging-Reducing Costs and Errors – Providing Budgetary Solutions

Med One Capital and Signostics are pleased to announce they have joined forces to provide clinicians with the latest in portable ultrasound technology coupled with customized financial options aimed at eliminating budgetary restraints and paving the way for immediate adoption.

In early May 2016, Signostics launched its newest technology at the American Urological Association meeting. When the attendees indicated an immediate need for financing it brought the two companies together, allowing acute care and private practices to move forward rapidly with this unmatched portable ultrasound technology.

Robb Stevens, SVP of Leasing Sales at Med One Capital, said, “We look forward to working with the Signostics team to provide our 25-plus years of experience financing medical technologies for healthcare providers. We recognize the value of this new technology and believe that together we can provide a simple and easy solutions for any customer to acquire it.”

Signostics VP of Sales, Ryan Detzel said, “We recognized that many customers would see immediate value in USCAN but would need help in finding the budget. Med One Capital was our number one choice based on their knowledge of our customers’ needs and their reputation for being committed to helping healthcare providers access new technology, as well as their simple and easy to understand process.”

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Signostics Receives FDA Clearance for Uscan™ – The World’s First Smart Mobile-Connected Visualization Device Specialized for Urologic Care

Uscan provides urologic visualization for efficient and more confident point-of-care clinical decision-making

KIRKLAND, WASH. – MAY 6, 2016 – Signostics, the global innovator in smart, high reliability ultrasound devices for urology, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Uscan™, the first smart mobile-connected ultrasound visualization device targeted at urologic care.

Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements than the industry standard* even on obese and other hard-to-scan patients. It acquires up to 256 bladder slices – 32 times more than conventional bladder scanners – resulting in industry-leading accuracy. It also provides real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement, for quick and easy visual tracking and observation.

“Uscan doesn’t just scan; it sees – providing intelligent urologic visualization by leveraging science from current-day computer vision algorithms aimed at more efficient and confident point-of-care clinical decision-making,” said Kevin Goodwin, CEO. “Uscan will exceed historical industry standards for bladder volume measurement accuracy yet will also enable use for other urologic imaging needs, reducing the delays and expense of engaging specialized ultrasound equipment or sonographers.”

Uscan also offers integrated middleware not found in any comparably priced systems; and can be used in a range of clinical settings beyond urology, including the emergency department, maternity, pediatrics, oncology, rehabilitation, aged care and home nursing. The system’s removable probe, high-resolution touch screen tablet and handheld displays make it ideally suited for on-the-go clinical care.

It is compatible with Android operating systems, and has built-in WiFi and Bluetooth connectivity that enables fast and reliable image management and interoperability with electronic health record (EHR) systems.

Uscan also offers the industry’s lowest cost of ownership in this market space, coming with a designed- in 5-year product warranty, with a “no fine print” pledge and requires no annual calibration. It is simple to learn and use, and provides real-time user guidance, eliminating the need for extensive training.

Signostics will introduce Uscan to U.S. healthcare providers attending the American Urological Association’s 2016 Annual Meeting (AUA 2016) May 6-10, 2016 in San Diego, California.

Uscan is anticipated to be commercially available in the U.S. by June 2016.

About Signostics

Signostics Inc. is a wholly owned subsidiary of Signostics Limited, a global medical device manufacturer with headquarters in the U.S. and offices in Australia, UK and Japan. Signostics, a KKR portfolio company, is pioneering smart ultrasound devices to enhance imaging and clinical decision making in urologic care. The company’s products include Uscan, SignosRT ultrasound systems and the SignosRT Bladder Scanner – ultra-portable, affordable devices designed to assist with the diagnosis of common medical presentations at the bedside. The company has regulatory approvals in the U.S., Australia, Canada, Europe, Singapore and Japan, and exports to countries around the world. For more information, visit www.signosticsmedical.com.

Signostics and Uscan are Trademarks of Signostics Limited.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

*Based on comparative measurements of a phantom of known volume.


For Media Inquiries Contact:
Jessica Donnelly
Edelman
(323) 202-1051
Jessica.Donnelly@edelman.com

Signostics Appoints Industry Innovator Dr. Niko Pagoulatos as Executive Vice President and Chief Innovation Officer

Signostics, a start-up innovator in the field of highly miniaturized ultrasound technology, today announced the appointment of Dr. Niko Pagoulatos to the position of Executive Vice President and Chief Innovation Officer (CIO). This announcement comes on the heels of a $35 million long-term investment from KKR, a leading global investment firm.

Dr. Pagoulatos brings his nearly 20-year track record as a successful innovator in the ultrasound industry to Signostics after holding senior technology leadership positions at SonoSite working alongside Signostics CEO Kevin Goodwin. He is the author of six issued patents and several scientific papers and is also one of the first researchers in the world to develop algorithms and publish scientific articles on the real-time fusion of ultrasound and MR/CR data sets. He received his Bachelor of Science in Physics from the University of Athens and completed his graduate studies at the University of Washington where he received a Master of Science in Bioengineering in addition to a Master and PhD in Electrical Engineering.

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Signostics Announces Investment and Capital Partnership with KKR

CLOVELLY PARK, SOUTH AUSTRALIA (November 16, 2015) – Signostics, a start-up innovator in the field of highly miniaturized ultrasound technology, today announced a private investment of $35 million dollars from KKR, a leading global investment firm.

Since launching its first product in 2009, Signostics has remained focused on the development of handheld ultrasound technology. The new funding by KKR will allow Signostics to pursue cutting-edge medical innovations and to expand and accelerate global marketing and distribution for new products. Prior to this transaction, Signostics re-domiciled from Australia to become a Delaware-based corporation with newly-established headquarters in Kirkland, Washington.

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