Medcity News

Disruptive, fast prototyping, iterative, warp speed. These are not words people typically associate with the U.S. Food and Drug Administration’s medical device review process. But in a media briefing on Monday, those words were bandied about liberally and signaled that federal bureaucrats are attempting to embrace a culture of innovation in their effort to help companies commercialize novel, safe products more quickly than before. In announcing the next phase or version 2.0 to the Innovation Pathway program introduced in February last year, CDRH Director Jeffrey Shuren said that the program is going to bring about a new way of...

500 Startups, the tech seed fund and startup accelerator founded by former Simply Hired and PayPal executive Dave McClure, is raising a second, $50 million fund to invest in more Internet-based startups. The firm invests $10,000 to $250,000 in seed funding to startups both directly and through its accelerator program, which is currently working with its fourth class. It also invests in startups at other accelerators, including Y Combinator and TechStars, with a focus on Internet-based companies with simple revenue models and functional prototypes. Areas of interest include consumer e-commerce, mobile and tablet services, cloud services and healthcare/wellness. This...

Bayer Corporation established a presence on Pinterest in recent weeks in a sign that pharmaceutical companies are beginning to warm up to the next generation of social media websites. Its section includes three bulletin boards on sustainability, innovation and this one, which illustrates the breadth of the corporation. It is also using Pinterest to link back to its pressroom, a way to engage potential consumers on interesting biotechnology topics like stem cells. Bayer also is using video to convey message, such as when it opened its innovation center in San Francisco to expand its life science collaborations last year....

Finding funding is one of the greatest challenges for an early-stage life science entrepreneur. That’s why industry experts and successful entrepreneurs have been recruited to address it as one of the key topics at the Kauffman Life Science Ventures Summit, hosted by theEwing Marion Kauffman Foundation on June 22 and 23. The Foundation recently announced a call for applications for the inaugural Summit, scheduled at the Mission Bay Conference Center at the University of California-San Francisco. During the Summit, industry experts will provide practical guidance on commercializing innovations in each of four sectors: medical device, therapeutics, diagnostics and digital...

With President Barack Obama signing the Jumpstart Our Business Startups Bill into law on Thursday, the crowdfunding provision could mark a new era for startups, making it easier to raise money with more investment from new investors fueling early and later stage healthcare companies. But some investors believe that with less rigorous regulatory checks and balances on company finances, the risk of investors getting burned by fraud will lead to new dynamics in the investment landscape, like novice investors partnering with individuals and groups with more experience. Three individuals from the investment landscape share their thoughts. Be careful what...

The U.S. Food and Drug Administration issued new guidelines Tuesday to help device makers understand how FDA reviewers evaluate premarket approval for high-risk devices and de novo submissions for moderate risk devices. In doing so, the agency reiterated a desire to provide clarity, consistency and transparency to a process that device manufactures have often charged as unpredictable, capricious and confusing. “In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Jeffery Shuren, director for the Center for Devices and Radiological...

Life science startups face more complex and daunting hurdles than new enterprises in non-regulated industries do. To help aspiring and early-stage life science entrepreneurs address these challenges, the Ewing Marion Kauffman Foundation will hold a Kauffman Life Science Ventures Summit June 22-23, 2012. The Foundation recently announced a call for applications for the inaugural Summit, scheduled at the Mission Bay Conference Center at the University of California-San Francisco. ’We surveyed early-stage and seasoned life science entrepreneurs to find out what they considered critical needs for starting their companies, and we built an agenda around their feedback,’ said Dominique Pahud,...

The bells, blips and signals emitted by medical devices, many of which are designed to alert medical staff if patients are in danger, pose the risk of being absorbed into the auditory landscape of hospital corridors and ignored, a problem referred to as “alarm fatigue.” The issue is coming under new focus at the U.S. Food and Drug Administration, which will explore ways to reduce the problem at American hospitals, according to a report in The Boston Globe. The FDA will focus on providing more training on alarm safety and standards to the people responsible for evaluating applications from...

A trade group for long-term care providers and an Ohio-backed investment organization have formed a venture capital initiative that will invest in startups that develop technologies to help people as they age. The group is called Linkage Ventures and was created by Linkage, a nonprofit made up of 600 senior living communities in 39 states, and state-backed CincyTech, according to a joint statement. The aim of Linkage Ventures is to identify, evaluate and invest in early stage technologies that startups can take to market to benefit the aging population directly or through care-giving organizations.The thinking is that Linkage’s members...