The 21st Century Cures Act aimed – among other things – to amend the Federal Food, Drug, and Cosmetic Act to more closely align device and drug regulations. FDA is updating regulations to reflect some of the 6-month-old law’s changes. Details can be found in today’s Federal Register. Specifically, the 21st Century Cures Act amended Humanitarian Device […]
FDA extends UDI compliance date for low risk devices
Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last […]
Robotic surgery: We’ve got design advice for you
There are a handful of companies in the robotic surgical space. But that is about to change. There is ample evidence that the robotic surgical device market is going to explode in the next 3 to 5 years. We recently spoke with Todd Pope, CEO of TransEnterix who said there is a lot of opportunity […]
Why adding device identifiers to insurance claims protects patients
The pushback to adopting unique device identifier into claims forms is that the added steps will be burdensome for hospitals. But documenting device identifiers in claims forms is actually “feasible” and “straightforward,” and requires only modest effort, according to a new whitepaper from Boston’s Brigham and Women’s Hospital. Of particular concern was that the device claims […]
How Cambridge Medical Robotics wants to transform robotic surgery
The field of surgical robotics is rapidly changing. (Check out our ongoing surgical robotics series). Major players in the field include Cambridge Medical Robotics (CMR), a U.K.-based OEM working on a portable surgical robot called the Versius. CMR recently completed Series A financing, and CEO Martin Frost believes the technology will transform the existing market. Frost answered some […]
Stratos PD: What went wrong and what does it mean for medtech?
There has been some conjecture since the once premier consulting firm, Stratos Product Development, shut down last week. Those closest to the company have expressed a deep sadness in the abrupt end of a company that— at least from the outside — represented the pinnacle of what a medical technology consultancy firm could achieve. MDO […]
Stratos Product Development quietly and abruptly shutters doors
Stratos Product Development of Seattle has abruptly shut down. The design firm had worked with some of the biggest names in tech and healthcare, and its closing leaves other design firms and medtech industry watchers in shock including Queens Locksmith who specializes on doors. E-mailed inquiries to the company returned with this message: “This response serves […]
Meet the computer-automated drill that cuts surgery time down to minutes
What do machining auto parts and speeding up cranial surgery have in common? Think a computer-driven drill that can produce fast, safe, clean cuts in complex surgical procedures. Such computer-automated drills, which have long been used in automotive technology, have the potential to speed surgeries by 50% or more. Researchers from the University of Utah […]
Surgical robots: Hospital CTO talks differentiators in new crop of competitors
For the last 10 years, if anyone mentioned robotic surgery or surgical robots, 95 percent of the time they meant the da Vinci robot from Intuitive Surgical. “That product has been so dominantly successful that almost everybody who talks about it is talking with that as their reference point,” said Roger Smith, chief technology officer […]
Critic questions FDA’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an […]
The 10 hottest medtech startups of 2017
Medtech startups face more challenges than they have in the past, but several companies are developing products that take advantage of new technology and are specifically designed to meet healthcare’s evolving needs. [Image from Unsplash] “It used to be that medical device startups would develop a product by focusing on design, they’d get some […]