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Custom Plastic Components For Medical Device OEMs. ISO 9001:2000 and ISO 13485:2003 certified Modified Polymer Components specializes in the design, rapid prototyping and manufacture of reliable, highly precise polymer components — performing modifications of any complexity to custom and off-the-shelf plastic components, with flaring, flanging, joining, tipping, coating, cutting, drilling, skiving and gluing. We can scale manufacturing cost effectively, so OEMs can create world-class components in limited to large quantities.
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Judge Rejects Plea Agreement in Guidant Defibrillator Case
A federal judge on Tuesday rejected a plea agreement between Boston Scientific and federal prosecutors, saying the proposed deal didn't do enough to hold the company accountable. The plea agreement, which was announced in February, called on Boston Scientific to pay the government $296 million and plead guilty to misdemeanor charges that its Guidant division misled federal regulators about hazardous problems with heart devices from 2002 to 2005. Read More
From Medtech Pulse - MPMN's Blog on Qmed
Texas Cashes in Chips for Cardiac Stents
As the saying goes, everything's bigger in Texas. And if recent activity in Austin is any indication, the medical device industry is no exception. Although not yet on par with Massachusetts, Minnesota, or Southern California, Texas is steadily cultivating the growth of this high-tech sector. Read More
FDA Approves New Device for Adults with Severe and Persistent Asthma
The U.S. Food and Drug Administration approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults. The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications. Read More
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Fishman AirFree™ Takes "Hot Air" Out of Competitors' Claims. Contrary to competitive claims, total process control is not possible with pneumatic dispensing systems. That's why Fishman AirFree™ technology uses positive displacement to make a perfect dot. See how you can achieve predictable results and control costs in a global manufacturing environment. More on AirFree Dispensing. In the US, call 800-433-2115. Outside the US, call +00 1 508-435-2115.
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Synergetics USA Enters into a Settlement and License Agreement with Alcon
Synergetics USA, Inc. announced the signing of a pair of agreements with Alcon Laboratories, Inc. granting Alcon a license to sell certain products manufactured by Synergetics for worldwide distribution on a co-exclusive basis throughout the extensive Alcon network and covering the terms of supply of such products to Alcon by Synergetics. The agreements also settle all litigation between Synergetics and Alcon. Read More
Wound Management Technologies, Inc. Announces Collaboration Project for Diabetic Disease Management
Wound Management Technologies, Inc. announced that its secure data delivery and messaging subsidiary Secure eHealth LLC has launched a project to develop a secure alert and messaging platform in collaboration with HealthPoints, Inc. a Dallas based disease management company. Read More
Cardiovascular Systems Receives Unconditional FDA Approval for ORBIT II Coronary Clinical Trial
Cardiovascular Systems, Inc. has received Food and Drug Administration unconditional Investigational Device Exemption approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360 System in the coronary arteries. Read More
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Download free PDF flow charts that clearly explain the regulatory approval process in Australia, Brazil, Canada, China, Europe, Japan, Korea, Mexico, Russia and the USA. Emergo Group can help you with international medical device regulatory compliance, quality assurance and medical distributor search consulting. Offices throughout North America, Europe and Asia. Request a free proposal for getting your medical device approved in any of these markets at www.EmergoGroup.com.
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Exactech Q1 Revenue Up 13%, Net Income Up 33% Reflecting Strong Surge in International Orthopaedic Sales and Decreased Legal Costs
Exactech, Inc. announced revenue of $49.1 million for the first quarter of 2010, a 13% increase over $43.3 million in the first quarter of 2009. Net income was $3.3 million, or $0.25 per diluted share, compared to $2.5 million, or $0.19 per diluted share, in the same quarter a year ago. Net income for the quarter, excluding pre-tax legal expenses and costs of $0.2 million related to the ongoing Department of Justice (DOJ) inquiry, was $3.4 million or $0.26 EPS. Read More
Alcon Independent Director Committee Notes that Novartis' Grossly Inadequate Merger Proposal Continues to Deteriorate Even in the Face of Alcon's Strong Earnings
The Alcon Independent Director Committee reiterated
that the Novartis merger proposal to minority shareholders of
Alcon is grossly inadequate and applauds Alcon for once again delivering
strong earnings results for its first quarter. Read More
Mesa Labs Acquires SGM Biotech, Inc.
Mesa Laboratories, Inc., a Lakewood, Colorado based manufacturer of electronic instruments and disposables, announced the acquisition of SGM Biotech, Inc., a Montana manufacturer of biological indicator products. Under the terms of the transaction, Mesa Labs has acquired all of the outstanding shares of SGM for approximately $12 million in cash, subject to certain net asset adjustments. Read More
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