FDA clears CoreLink’s new spinal implant

Spinal implant maker CoreLink has landed FDA 510(k) clearance for a new anterior lumbar (ALIF) interbody device. The Foundation 3D ALIF uses the company’s proprietary mimetic metal technology, which mimics natural bone characteristics, including 100% open-pore architecture and micro-roughened porosity with hydro-wicking properties. The new ALIF design also has patent-pending technology that creates a combination of

Smithwise helps startup find its focus

After Basil Leaf Technologies won the Qualcomm Tricorder XPrize in 2017, founder Dr. Basil Harris needed help figuring out how to bring this almost-all-in-one diagnostic tool to market. Basil Leaf’s mobile platform DxtER includes a group of non-invasive sensors that can wirelessly communicate with a smart device as they collect data on vital signs, body

Spectralytics invites customers to ‘camp out’ at new development center

Spectralytics has completed a dedicated product development center in Maple Plain, Minn. to speed delivery of prototypes to customers and free up the production lines in its other facilities. Spectralytics’ two existing plants in Dassel, Minn., 55 miles west of the Twin Cities, offer laser cutting, welding, drilling, ablation, marking, electropolishing, assembly, and engineering services

Dune Medical debuts waste-saving surgical probe

Dune Medical Devices has designed a reposable version of its MarginProbe radiofrequency spectropscopy device, which can help surgeons identify remaining cancer cells in real time during a lumpectomy. The updated MarginProbe has a  reusable cable and handle and a single-use attachable probe. It has the potential to reduce waste burden of the MarginProbe up to

Medical devices: When should you make them smarter?

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

Medtech companies need to expand their philosophy: Here’s why

Medtech companies should expand their notion of who their customers are and dig deeper to discern what those customers want, according to health provider- and insurer-connected experts at the recent DeviceTalks Minnesota in St. Paul. Artificial intelligence and the proliferation of healthcare data have made it possible for medtech to consider not just individual patients

Softwheels, Igus redefine the wheel in wheelchair

Thomas Renner, Catalyst Marketing Communications When engineers at SoftWheel set about re-inventing the wheel, the team at the Israel-based company studied their product from the inside out. The result is a much smoother ride for wheelchair patients, with applications for bicycles, automobiles and even planes on the long-term horizon. The technology behind SoftWheels for wheelchair patients

Common Sensing, Flex partner to redesign digital insulin pen sensor

Common Sensing said today that it has enlisted design company Flex to help redesign its Gocap insulin pen device. Flex is tasked with finding materials to help extend the product’s battery life, as well as boost measurement accuracy and prepare for high volume manufacturing. Get the full story at our sister site, Drug Delivery Business News.

Nortech Systems expands China manufacturing facility

Nortech Systems recently announced that it is expanding its Suzhou, China manufacturing space. The new manufacturing space will be 15,000 sq. ft bigger than it currently is and will still offer Nortech Systems’s full-service electrical manufacturing services. This expansion comes after the Maple Grove, Minn.-based company expanded its Mexico operations in February by building a new

Will FDA turn to neuroscience-based human factors research?

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

Webinar: How to balance regulations and performance with your medical device design

This webinar was presented live on Wednesday, June 20, 2018. Click below to watch on demand.     Creating a medical device that meets both regulatory compliance and performance requirements takes careful planning. You also need to understand the most efficient path to market commercialization in order to stay within budget and on schedule. This

Greenlight Guru’s newest software version enhances QMS, complex design tracking

Greenlight Guru — which offers cloud-based quality management software specifically for medical device companies — recently announced Multi-Level Design Control, the latest version of its purpose-built medical device design traceability software. The new platform improves on Indianapolis-based Greenlight Guru’s previous offering that moved design controls off the paper and into the cloud, said Greenlight Guru co-founder

7 ways you can doom your medical device startup

Randy Nelson has worked with medical device startups for more than a dozen years through his Evergreen Medical Technologies (St. Paul, Minn.), as well as the University of Minnesota’s Carlson School of Management. A product development veteran of St. Jude Medical and Boston Scientific, Nelson has pretty much seen it all when it comes to

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Drug delivery needs better human factors

Adopting neuroscience-based human factors methods could yield better outcomes for patients, improved communication design and engineering teams, and maybe even help companies build IP. The methods behind assessing human factors in medtech are outdated—and they’re due for an upgrade, said Charles Mauro CHFP, of Mauro Usability Science. “The type of research employed to determine if

This new PTFE seal could make insulin pumps and other medical devices better

In dynamic applications requiring sealing at low-to-moderate speeds and pressures, design engineers are replacing underperforming elastomeric O-rings with spring-energized PTFE “C-ring” seals. David Wang, Bal Seal Engineering When O-rings and other traditional sealing methods fail, diagnostic and drug-delivery equipment engineers are embracing a new and more cost-effective way to improve the performance of their existing