Widespread screening or routine ultrasound for blocked neck arteries to determine stroke risk isn't necessary, according to new guidelines from the American Heart Association/American Stroke Association (Dallas), American College of Cardiology (Washington) and other groups. (Medical Device Daily)

In a recent survey of biomedical CEOs in California, 80% said their companies have been courted by other countries, state governments or regional economic development associations in the past year. Yet the same survey, the 2011 California Biomedical Industry Report, also found consensus of confidence in the state's ongoing attractiveness to the biomedical industry, with many CEOs planning to increase jobs, manufacturing, and R&D operations within California vs. elsewhere. (Medical Device Daily)

The $296 million Boston Scientific (Natick, Massachusetts) paid in late 2009 to settle an investigation with the U.S. Department of Justice (DoJ) evidently was not enough to put the matter to rest once and for all. The DoJ filed a lawsuit this week against Boston Scientific, accusing the company of knowingly selling defective implantable defibrillators. (Medical Device Daily)

Last week Boston Scientific (Natick, Massachusetts) added Atritech (Plymouth, Minnesota) to its shopping list, announcing its intention to acquire the company for $100 million upfront plus potential payments of up to $275 million. The deal gives Boston Scientific a device backed by strong clinical evidence and puts the company in an ideal position in the endocardio left atrial appendage (LAA) market, according to Karene Dumoulin, principal analyst of cardiovascular at Millennium Research Group (MRG; New York). (Medical Device Daily)

Corindus Vascular Robotics (Natick, Massachusetts), a developer of precision vascular robotics, said it has been granted a conditional investigational device exemption (IDE) from the FDA to evaluate the safety and effectiveness of its CorPath 200 system in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions (PCI). (Medical Device Daily)

Everist Genomics (Ann Arbor, Michigan), a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, reported the positive results of the first external validation study of its OncoDefender-CRC colorectal cancer recurrence test. The study is being conducted by Mayo Validation Support Services, an affiliate of the Mayo Clinic (Rochester, Minnesota) and is being coordinated with investigators and resources from all three Mayo Clinic sites. (Medical Device Daily)

So far it seems promising, but the true impact of the FDA's newly unveiled 510(k) plan will lie in the details and how the changes are implanted. That is the conclusion many in the industry have come to in the wake of Wednesday's announcement by FDA. The agency had decided on 25 actions to move forward on this year in an effort to improve the controversial review process. (Medical Device Daily)