FDAnews Device Daily Bulletin
Jan. 21, 2005 | Vol. 2 No. 15
Mark McClellan, administrator of the Centers for Medicare & Medicaid Services (CMS), said the agency was "poised to expand" coverage of implantable cardioverter-defibrillators (ICDs) based on new research showing they could increase the chances of survival in substantial numbers of elderly people on Medicare.
One-hundred percent of people facing almost-certain amputation were successfully treated with a new nonsurgical therapy that gently cools and opens leg arteries clogged with plaque, according to preliminary data on 22 patients presented at the 17th Annual International Symposium on Endovascular Therapy.
The MedSystems business unit of VIASYS, a provider of enteral feeding devices, recently received FDA clearance to market the CORTRAK system, a patented device designed to aid in the placement of enteral feeding tubes.
Advanced Sterilization Products, a developer of instrument processing technologies, has announced the Canadian launch of the STERRAD NX Sterilization System, its next-generation low-temperature hydrogen peroxide gas plasma sterilizer for rapid processing of medical devices and surgical instruments.
Lumera has received the third in a series of patents covering the company's fundamental technology. This patent family protects the highly efficient electro-optic materials and devices that Lumera is developing and bringing to market.
Rubicor Medical, maker of the EnCapsule minimally invasive breast biopsy devices, has announced that the lawsuit filed against it by Neothermia for breach of contract and patent infringement has been dismissed.
Chembio Diagnostics has filed a new patent application with the U.S. Patent and Trademark Office for a novel method and device incorporating lateral flow technology, which the company believes provides it with a proprietary platform upon which it will be able to develop several new rapid tests.
SurModics, a provider of surface modification and drug delivery technologies to the medical device industry, has made an equity investment of approximately $3.9 million in OctoPlus, a privately owned company based in the Netherlands active in the development of pharmaceutical formulations incorporating novel biodegradable polymers.
Advanced Global Industries has signed a merger agreement to acquire all of the issued and outstanding shares of Synova Healthcare of Media, Pa.
OctoPlus has raised $23.85 million in a second financing round from an international group of investors. The investment was led by Life Sciences Partners and S.R. One.
ORTHOsoft, a developer of computer-assisted orthopedic surgery technology, has announced that its Navitrack Navigation System is now available and successfully being used by a number of Tampa-area surgeons, hospitals and surgery centers to optimize the results of total knee and total hip replacements.
Lifestream Technologies, a supplier of cholesterol monitors, has unveiled a concept product at the recent FDA hearing on an OTC petition for a cholesterol lowering drug.
A noninvasive fingertip test can identify coronary disease at its earliest stages and may provide an easy to use tool for daily clinical practice, according to a recent study published in the Journal of the American College of Cardiology.
BeamOne entered into a definitive agreement to acquire the medical products irradiation service centers of Titan Scan Technologies.
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