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Regulatory Roundup

IsoRay’s brain cancer treatment cleared by the FDA

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World’s Only Liquid Radiation Balloon Catheter Device Treats Glioblastomas and Metastasized Brain Cancers

RICHLAND, Wash.–(BUSINESS WIRE)–IsoRay, Inc. (Amex: ISR) announced today that the FDA has cleared its GliaSite® radiation therapy system, a balloon catheter device used in the treatment of brain cancer. The clearance was the major step required to return the GliaSite® radiation therapy system to the marketplace. The system’s balloon catheter is a landmark technology that allows physicians to treat more brain cancer patients than ever before with internal radiation or brachytherapy.

VisionCare’s macular degeneration device now available for Medicare patients

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Approval of device pass-through payment allows eligible Medicare beneficiaries new AMD treatment option access

SARATOGA, Calif., Sept. 8, 2011 /PRNewswire/ — VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced that the Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through payment status and established a billing code for the Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) under the Hospital Outpatient Prospective Payment System. The new pass-through code, C1840, is effective October 1, 2011 and will enable outpatient facilities to obtain reimbursement for the telescope implant for covered procedures.

Fujifilm’s digital mammography system gets FDA clearance

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Durable Full Field Digital Mammography (FFDM) system features unique detector technology providing exceptional imaging quality

STAMFORD, Conn., Sept. 12, 2011 /PRNewswire/ — Breast Imaging facilities looking for increased diagnostic confidence in mammography screening can now benefit from the exceptional image quality of the Aspire™ HD Full Field Digital Mammography (FFDM) system from FUJIFILM Medical Systems U.S.A., Inc. Now FDA 510(k) cleared, the Aspire HD provides image clarity that enables extraordinary detail of potential abnormalities that not only assists in more accurate and reliable diagnoses, but also results in enhanced clinician productivity.

(Photo: http://photos.prnewswire.com/prnh/20110316/NY65935)

Avedro announces FDA orphan drug designation for VibeX

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VibeX™ Riboflavin/KXL™ System for the Treatment of Keratoconus
WALTHAM, Mass.–(BUSINESS WIRE)–Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s VibeX (0.1.% riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat Keratoconus. Keratoconus is a degenerative disease of the eye and is the leading cause of corneal transplants in the United States today.

WideMed gets FDA clearance for sleep diagnostic system

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HERZLIYA, Israel–(BUSINESS WIRE)–WideMed (TASE:WDMD), a leading company engaged in the research, development and sale of innovative products for the growing bio-medical signal diagnostics and treatment market, announced today that the U.S. Food and Drug Administration has granted its home sleep monitoring device, Morpheus Ox, clearance to market in the United States for cardiac patient population.

Morpheus® Ox is WideMed’s portable home sleep diagnostic and monitoring solution. Easy to use, watch-size device enables to perform a sleep test in the comfort of the patient own bedroom.

Miracor secures $10 million in series B | Funding Roundup

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Miracor

Private medical device company, Miracor Medical Systems GmbH, secured $10 million in the first closing of the series B financing round. Second closing is pending approval by investors.

Austria Wirtschaftsservice and German venture capital investment group SHS Gesellschaft für Beteiligungsmanagement joined existing investors, Earlybird and Delta Partners, to support Miracor’s financing round.

Endologix lands conditional IDE approval for their stent graft system | Regulatory Roundup

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Endologix

Irvine, Calif.-based Endologix, Inc. (NSDQ:ELGX) won conditional Investigational Device Exemption (“IDE”) approval from the FDA to begin U.S. clinical trials to evaluate their Ventana renal stent graft system.

Endologix plans to start enrolling patients in trials before the end of this year to evaluate the success of the Ventana system, a stent graft for the endovascular repair of renal aortic aneurysms.  It is designed for use with the company’s AFX endovascular system and Xpand rental stent grafts.

Optos gains on Project Daytona FDA clearance | MassDevice.com Regulatory Roundup

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Optos

Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.

The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.

Neoprobe presses past controversy, submits Lymphoseek NDA| Regulatory Roundup

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Neoprobe

Cancer diagnostics firm Neoprobe Corp. (NYSE Amex:NEOP) pressed past the controversy surrounding its Lymphoseek radiopharmaceutical and submitted a new drug application for FDA review.

The Dublin, Ohio-based company hopes to win clearance for Lymphoseek for use in intraoperative lymphatic mapping, a surgical procedure that identifies and biopsies lymph nodes for traces of cancer.

St. Jude enrolls first patient into heart rhythm early intervention trial | Regulatory Roundup

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St. Jude

St. Jude Medical Inc. (NYSE:STJ) enrolled the first patient into its pan-European study of early interventions of irregular heartbeat.

St. Jude can enroll more than 3,000 patients across 200 centers in Europe, including locations in Belgium, the Czech Republic, Denmark, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland and the United Kingdom.