Robotic spine surgery is getting a real-time image guide boost

For the first time, surgeons at Johns Hopkins Hospital were able to harness real-time image guidance during a robotic spine surgery procedure to insert screws into a patient’s spine. The process offers a marked improvement over the accuracy of placement compared with other image-guided procedures. Dr. Nicholas Theodore – professor of neurosurgery at the Johns Hopkins University

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

How startup Nanowear partnered with Secant: It took a year and a lot of meetings

Nanowear, which creates cloth-based diagnostic monitoring nanosensor technology, has entered into an exclusive, worldwide supply-chain partnership agreement with The Secant Group for scaled manufacturing and production of its medical-grade cloth-based nanosensor technology. Under the agreement, Nanowear and The Secant Group will have the collective obligation for marketing the technology and associated products. Nanowear received FDA 510(k) clearance for its remote congestive heart

Bringing medical device manufacturing back to the U.S.: Here’s how it’s done

Here’s an inside look at one organization’s decision to bring medical device manufacturing back onshore. John Thomas, Bonifacio Consulting Services Deciding where and how to manufacture a product is without a doubt one of the most important decisions a medical device OEM faces. This decision has many implications, from the overall successful manufacture of the product

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.

What is the future of medtech in 2018?

Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace of the new healthcare ecosystem. Medical device companies are putting greater emphasis on value-based arguments for their products and services. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and

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How BioSig is using plug and play as a medtech startup strategy

Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during

PEEK formulations for new implantable devices

Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucency and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer. Lawrence Acquarulo, Foster Corp. Polymers have always played a role in modern implantable medical devices. But until

Repeat sterilization for adhesives in reusable and non-disposable devices

Here’s a review of the common adhesive materials and their reaction to sterilization processes. Christine Marotta, Henkel Intricate medical devices are often constructed of thermoset and other engineered plastics, which require advanced adhesive technology. In addition to considerations of bonding, sealing, gap filling, and manufacturability, developers need to consider the sterilization plan that all materials, including

ChemSpec’s to distribute Dispersix adhesives

ChemSpec is now offering Dispersix silicone processing additives following a new distribution deal with Spherix Mineral Products. The recently-announced partnership with Spherix Mineral Products allows ChemSpec to offer medical device manufacturers and suppliers with additives that can improve silicone products. Dispersix is used in high consistency rubber (HCR) silicone cure chemistries. Aluminosilicates are recovered from

Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

How to collaborate better with a product design firm

There are a number of things that medical device companies can do to ensure that their partnerships result in well-designed devices. Here are a few tips for successfully navigating a partnership with a product design firm. Sonja Takatori, Product Creation Studio So you’ve successfully interviewed, evaluated and selected a design firm to partner with on

These 5 surgical startups want to build the OR of the future

As with most medtech advances these days, a running theme among top surgical startups is value. Innovators presented their surgical platform products in various stages of development at this year’s AdvaMed MedTech Conference as part of the Medtech Innovator Program, offering a view of the future of ORs across the world. As mentioned, there are some running

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Middleware: How it’s changing medtech

Medtech developers can take advantage of middleware technology to gain a competitive advantage. Tim Gee, Medical Connectivity Consulting Two macro trends are affecting how medical devices and systems are designed: Adoption of off-the-shelf (OTS) computing technology to extend the power and capabilities of traditional embedded system medical devices; and the evolution of software architectures that greatly

OCTANe: Southern California leads in medtech jobs and job creation

Southern California in recent years provided the highest level of employment to medtech, according to U.S. Dept. of Commerce data compiled by OCTANe. Bill Carpou, OCTANe’s president and CEO, presented the statistics during his welcome address at the Medical Technology Innovation Forum (MTIF) earlier this week. The area including Los Angeles, Orange County, and San Diego employed