Medical Devices News and Research

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First Edition: May 17, 2010

Today's headlines highlight stories about efforts to advance the implementation of federal health reforms as well as the sweeping measure's political impact in primary races across the country.

17 May 2010

IpAuctions schedules sale of Zassi's pouchless ostomy management technology IP portfolio

IpAuctions™ has scheduled a live international corporate sale of the extensive IP portfolio of pouchless ostomy management technologies owned by Zassi Holdings, Inc. Zassi, the Florida-based firm, fosters breakthrough medical devices that are materially evolving the life sciences industry.

15 May 2010

Hospira's I.V. administration set product line to be standardized to non-DEHP

Hospira, Inc., a leading global specialty pharmaceutical and medication delivery company, will expand its commitment to non-DEHP products by transitioning customers to its portfolio of non-DEHP intravenous administration sets.

15 May 2010

PLC Systems reports total revenues of $1,062,000 for first-quarter 2010

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three-month period ended March 31, 2010.

14 May 2010

Tiny cell bricks hold potential for building artificial tissue

Tissue engineering has long held promise for building new organs to replace damaged livers, blood vessels and other body parts. However, one major obstacle is getting cells grown in a lab dish to form 3-D shapes instead of flat layers.

14 May 2010

Viking Systems announces positive response to 3DHD camera-display combination at Hospital Build Asia 2010

Viking Systems, Inc. today announced an overwhelmingly positive response to the demonstration of the 3DHD combination of Viking's cameras with Sony's 3DHD display by those who had the opportunity to experience it earlier this week in Singapore at Hospital Build Asia 2010 Exhibition and Congress.

14 May 2010

FREEDOM trial results to be presented at Heart Rhythm 2010

St. Jude Medical, Inc., a global medical device company, today announced results of the FREEDOM trial during the late breaking clinical trial presentations at Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions. The trial demonstrated that the QuickOpt optimization feature available in St. Jude Medical cardiac resynchronization therapy devices produces an equivalent response rate in CRT patients as optimization using echocardiography.

14 May 2010

St. Jude Medical announces FDA clearance and CE Mark approval for EnSite Derexi module

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) clearance, CE Mark approval and the launch of the EnSite Derexi™ module, which provides improved electrophysiology (EP) lab efficiency and workflow by enabling communication between the EnSite™ Velocity™ Cardiac Mapping System and the EP-Workmate™ Recording System.

14 May 2010

Derma Sciences first-quarter net sales up 23% to $12,844,382

Derma Sciences, Inc., a specialty medical device/pharmaceutical company focused on advanced wound care, reported financial and operating results today for the three months ended March 31, 2010.

14 May 2010

St. Jude Medical to display new products, clinical solutions at Heart Rhythm 2010

St. Jude Medical, Inc., a global medical device company, today announced it will display a number of new products and clinical solutions from the company's Cardiac Rhythm Management and Atrial Fibrillation Divisions at Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.

13 May 2010

FDA approves St. Jude Medical's Unify CRT-D and Fortify ICD devices

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval and first U.S. implants of its Unify™ cardiac resynchronization therapy defibrillator (CRT-D) and Fortify™ implantable cardioverter defibrillator (ICD). The new devices feature advanced battery technology and circuitry that allow for the smallest device footprint in the industry and rapid charge times, without any compromise in device longevity or power.

13 May 2010

TSO3 first-quarter net loss increases to $2,033,932

TSO3 Inc. an innovator in sterilization technology for medical devices in healthcare settings using ozone, posted revenues of $144,228 for the sales of consumables and services for its first generation STERIZONE(R) Sterilizer (125L) for the first quarter ended March 31, 2010. This compares with $533,488 for the same period in the prior year in which three sterilizers (125L), consumables and services were sold.

12 May 2010

Japanese MHLW approves St. Jude Medical's AnalyST ICD with ST Monitoring device

St. Jude Medical, Inc., a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) of its AnalyST™ implantable cardioverter defibrillator (ICD) with ST Monitoring, a revolutionary device that not only provides life-saving therapy for dangerously fast heart rhythms, but also continuously monitors electrical changes (called ST segments) to help physicians monitor for cardiac problems.

12 May 2010

St. Jude Medical launches Promote Quadra CRT-D in Europe

St. Jude Medical, Inc., a global medical device company, today announced the European launch of its Promote Quadra™ cardiac resynchronization therapy defibrillator (CRT-D). The Promote Quadra CRT-D is the industry's first quadripolar pacing system, which offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure.

12 May 2010

SonarMed AMS technology obtains FDA clearance

SonarMed, a developer and manufacturer of critical care respiratory monitoring technologies, announced that it has received Food and Drug Administration clearance for its patented SonarMed Airway Monitoring System, which monitors breathing tubes for patients requiring ventilators.

12 May 2010

IMBio receives regulatory concurrence from FDA to market OCL 500 microspheres in the U.S.

IMBiotechnologies Ltd., a privately held biotechnology company focused on developing medical device products for use in the area of embolotherapy, today announced that it has received regulatory concurrence from the United States Food and Drug Administration to market its lead product, Occlusin 500 Artificial Embolization Device in the U.S. for the treatment of unresectable/inoperable hypervascularized tumours.

12 May 2010

Australian TGA approves Acetadote for treatment of paracetamol poisoning

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.

12 May 2010

$2.8 billion U.S. peripheral vascular device market to grow to over $5.3 billion by 2016

According to a new report by iData Research, the leading authority in medical device and pharmaceutical market research, the U.S. peripheral vascular device market is worth $2.8 billion with expected growth to over $5.3 billion by 2016. Increased detection and treatment of abdominal aortic aneurysms (AAAs) and peripheral arterial disease (PAD) are the main drivers of this market, particularly in the stent-graft and peripheral vascular stent segments. These markets are both expected to exceed $1 billion by 2016.

11 May 2010

Viking Systems to demonstrate 3DHD Vision System prototype at Hospital Build Asia 2010

Viking Systems, Inc. today announced that a prototype version of its Next Generation 3DHD Vision System will be demonstrated with Sony's prototype 3DHD Medical Display in Sony's booth at Hospital Build Asia 2010 which will run May 11 -13 in Singapore.

11 May 2010

Hothead Technologies, Shafer partner to develop normothermia monitoring and management system

Hothead Technologies has executed an agreement with Shafer Medical Devices, a Division of Shafer Enterprises, LLC to develop and distribute a medical application of the H.O.T.™ System that supports the Shafer Medical Devices Hypo/Hyperthermic Pad in managing normothermia in patients, during pre-op, surgery, and post op.

11 May 2010

Medical Devices News and Research

First Edition: May 17, 2010

IpAuctions schedules sale of Zassi's pouchless ostomy management technology IP portfolio

Hospira's I.V. administration set product line to be standardized to non-DEHP

PLC Systems reports total revenues of $1,062,000 for first-quarter 2010

Tiny cell bricks hold potential for building artificial tissue

Viking Systems announces positive response to 3DHD camera-display combination at Hospital Build Asia 2010

FREEDOM trial results to be presented at Heart Rhythm 2010

St. Jude Medical announces FDA clearance and CE Mark approval for EnSite Derexi module

Derma Sciences first-quarter net sales up 23% to $12,844,382

St. Jude Medical to display new products, clinical solutions at Heart Rhythm 2010

FDA approves St. Jude Medical's Unify CRT-D and Fortify ICD devices

TSO3 first-quarter net loss increases to $2,033,932

Japanese MHLW approves St. Jude Medical's AnalyST ICD with ST Monitoring device

St. Jude Medical launches Promote Quadra CRT-D in Europe

SonarMed AMS technology obtains FDA clearance

IMBio receives regulatory concurrence from FDA to market OCL 500 microspheres in the U.S.

Australian TGA approves Acetadote for treatment of paracetamol poisoning

$2.8 billion U.S. peripheral vascular device market to grow to over $5.3 billion by 2016

Viking Systems to demonstrate 3DHD Vision System prototype at Hospital Build Asia 2010

Hothead Technologies, Shafer partner to develop normothermia monitoring and management system

Industry Focus eBook - Medical Devices (3rd Edition) eBook

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