More than 98% of the 161 foot and ankle devices that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process
Medical devices: When should you make them smarter?
June 20, 2018 By Leave a Comment
The drive toward value in healthcare has increased demand for smarter medical devices able to provide information for real-time feedback, as well as after-the-fact analysis. So when does it make sense to actually make a medical device smarter? And how do you go about it? Tom KraMer, CEO of Kablooe Design outside Minneapolis, has a
Will FDA turn to neuroscience-based human factors research?
May 21, 2018 By Leave a Comment
There is a new wind blowing in medical technology — one that many believe is overdue: an overhaul of human factors. At the recent Patient Safety Initiative, Charles Murphy, Chief Patient Safety Officer at the Inova Heart and Vascular Institute, called out human factors as one of the key factors he believed needed to be
Estone Technology launches rugged medical tablet
May 1, 2018 By Leave a Comment
Estone Technology recently launched its rugged medical tablet, MD-100, to follow the trend the healthcare market is seeing with increasing dependence on automation for improved patient care. The new medical tablet PC features the full MIL-STD-810G ruggedness that Estone Technology is used to offering. It also uses Intel Apollo Lake or Kaby Lake processor technology
AI could be a game-changer for older people and cognition
April 30, 2018 By Leave a Comment
As the founder and CEO of MyndYou, Ruth Poliakine-Baruchi believes strongly in the power of artificial intelligence to change health. MyndYou is an AI healthcare company dedicated to identifying and tracking cognitive changes in older adults. The goal is to help these adults stay with their families longer and gain better care than they might get
Razorleaf opens first international division
April 24, 2018 By Leave a Comment
Razorleaf (Stow, Ohio) announced that it has opened its first division outside of the U.S. in Northampton, U.K. The company’s new Razorleaf Europe will provide a single delivery and support service to customers in Europe. “We’ve already done projects in Europe, and have customers with both U.S. and European presence, but as we get into
Medtech’s top leaders commit to interoperability – but can the data back it up?
April 16, 2018 By Leave a Comment
Integrating data into the care process holds a great deal of promise for the healthcare industry. But medical device industry leaders agree that there are system complexities that need to be solved — with lack of good data a critical issue. That was a major takeaway from a Healthcare Technology Leadership Panel at the 6th Annual
China’s private hospital revenue expected to triple by 2019
April 13, 2018 By Leave a Comment
Grace Palma, China Med Device The public healthcare system in China is getting overcrowded. Medical resources are getting stretched thin and this is particularly evident in level III public hospitals. The government, aware of the challenges, has opened up the healthcare system to private investments as outlined in its 13th five-year plan. At the same time,
Masimo launches UniView data integration system
April 9, 2018 By Leave a Comment
Masimo (Irvine, Calif.) recently announced that it has launched its UniView system to help promote data sharing and team coordination between multiple clinicians. The UniView system is an integrated display of real-time data and alarms that others its information from a number of Masimo and third-party devices. It helps clinicians in operating rooms, intensive care
Allina Health and Zipnosis partner to expand online care platform
March 30, 2018 By Leave a Comment
Minneapolis-based Allina Health and Zipnosis have recently partnered to update Allina Health’s online diagnosis and treatment service. Allina Health — a major Twin Cities health system — recently launched its Everyday Online platform that is powered by virtual care company Zipnosis. Allina Health Everyday Online is designed to bring convenient access to patients through Minnesota and Western Wisconsin.
7 digital health startups you need to watch in 2018
March 30, 2018 By Leave a Comment
If you want to see where the big money is going in healthcare these days, digital health products are the place to look. Digital health startups raised $11.5 billion in 2017, up 27 percent over 2016, according to the StartUp Health Insights Year End Report. Digital health startups are doing everything from enhancing patient-provider relationships to
Genae acquires Hilbert Paradox
March 30, 2018 By Leave a Comment
Medical device contract research provider Genae (Antwerp, Belgium) recently acquired the digital health data management platform Hilbert Paradox. The financial details of the deal were not disclosed. Hilbert Paradox (HPX) captures and correlates digital health data by using different computing power, AI and data analytics. The company’s goal is to increase health data equity to improve
10 women medtech leaders you should know
March 23, 2018 By Leave a Comment
There is a women’s leadership gap in the U.S., and women in medtech have been working to alleviate that problem. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% are CEOs, 8.1% are top earners and 4.6% are Fortune 500 CEOs. More specifically,
Minor orthopedic implant market to be worth $2.2 billion by 2021, analysts say
March 21, 2018 By Leave a Comment
The minor orthopedic replacement implant market will grow from $1.5 billion in 2017 to $2.2 billion in 2021, according to analysts from The Business Research Co.. The company’s Minor Orthopedic Replacement Implants report said the industry will experience an annual growth rate of over 7%, driven by a higher rate of arthritis and fractures. Osteoarthritis
Risk management for cloud-powered medtech: What you need to know
March 19, 2018 By Leave a Comment
Cloud-enhanced medical devices are on the rise. There are some incredible benefits to the trend, as well as some increases in risk. Medtech developers should take note of the risks to properly develop a risk management strategy. Michael Ford, Pro Back Office As we kickstart 2018, there are increasing concerns and risk challenges for the
