Fdanewsdevicedailybulletin

July 18, 2005

Vol. 2 No. 139

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ENPATH DEVICE APPEAL REJECTED BY FDA

Medical devicemaker Enpath Medical said the Office of Device Evaluation (ODE)at the FDA denied the company's appeal of the decision by the ODE staff that the pending premarket application of its Myopore Rx steroid lead is not approvable as currently submitted.

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FDA CLEARS ARTHROCARE PRODUCT

The FDA has cleared ArthroCare's Parallax Acrylic Resin with TRACERS-TA Bone Cement Opacifier for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

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COMPANY GETS IDE FOR MITRAL REGURGITATION TRIAL

The FDA has granted Cardiac Dimensions investigational device exemption (IDE) approval to initiate its COMPETENT pilot study of the CARILLON Mitral Contour System for treatment of mitral insufficiency in patients suffering from heart failure.

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PROTEIN POLYMER TECHNOLOGIES ANNOUNCES INTENTION TO ACQUIRE SURGICA CORPORATION

Protein Polymer Technologies, Inc. (OTC Bulletin Board: PPTI), a biotechnology device company that is a pioneer in protein design and synthesis, announced today that it has issued a letter of intent to acquire Surgica Corporation, a medical device company that develops, manufacturers and markets embolization products.

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STEREOTAXIS SETTLES PATENT LICENSE DISPUTE

Stereotaxis Inc. on Friday said it will pay nearly $3.7 million to settle a patent licensing dispute, which will result in a one-time charge. The company makes a cardiology instrument control system that allows physicians to navigate catheters and guidewires in heart-disease patients.

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ESTRACURE SIGNS LICENSING AGREEMENT FOR USE OF MEDIVAS EXCLUSIVE DRUG DELIVERY TECHNOLOGY

Dr. Marc Lussier, Chief Executive Officer of Estracure, Inc., a subsidiary of Duravest, Inc., a publicly traded holding company (OTC BB: DUVT, XETRA: DUV) and Kenneth Carpenter, President and CEO of San Diego based MediVas LLC, announced today the signing of an agreement for the exclusive use of the MediVas PEA drug delivery technology in conjunction with Estracure's core technology to develop a 17-(beta)-Estradiol drug-eluting stent (DES) to treat patients suffering from coronary heart diseases.

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MATRITECH REPORTS NOTIFICATION OF MARKETING APPROVAL IN JAPAN FOR ITS NMP22 BLADDERCHEK TEST

Matritech, Inc. (Amex: MZT) a leading developer of protein-based diagnostic products for the early detection of cancer, today announced it has been notified by its distribution partner in Japan that its point-of-care cancer diagnostic NMP22(R) BladderChek(R) Test received marketing approval from the Japanese Ministry of Health, Labor and Welfare for testing of bladder cancer.

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OCIMUM BUYS GERMAN CO'S GENOMIC DIAGNOSTICS DIVISION - TO MERGE US, INDIA OPERATIONS

Ocimum Biosolutions, a life sciences company, has acquired the Genomic Diagnostics division of the German MWG Biotech AG.

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MIV THERAPEUTICS SUCCESSFULLY COMPLETES ANIMAL FEASIBILITY STUDIES OF STROKE-PREVENTION DEVICES

MIV Therapeutics, Inc. (OTCBB:MIVT), a developer of next-generation biocompatible stent coatings and drug delivery technologies, has successfully completed Phase I animal feasibility studies in sheep of two models of a novel implantable arterial filtration technology device designed to prevent strokes by diverting embolic particles flowing through the bloodstream.

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