How Magnolia Medical is battling sepsis false-positives for better value

Seattle-based Magnolia Medical Technologies – which says it makes a dramatic improvement to sepsis testing – provides a great example of the new value arguments dominating medtech. Sepsis happens to be a big deal. Hospital patients are often susceptible to sepsis, a bacterial infection that is the fifth leading cause of death. The standard of care

These antique surgical kits will make you glad you live today

Right about now, Indiana Jones is exclaiming: “They belong in a museum!” RR Auction house recently auctioned off antique surgical kits that a Harvard Medical School founder used during the American Revolution. The two kits, plus two other post Revolution-Era items sold for $104,000, CNN reports. Two kits were owned and used by Continental Army surgeon Dr.

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The ins and outs of microextruded medical tubing

Microextruded medical tubing could enable increasingly smaller surgical and home care products, according to Tekni-Plex’s Natvar.  Surgical and home care products including catheters are becoming increasingly complex and smaller in size. Neurovascular interventional therapies and surgical procedures also require tight tolerances for those small sizes. Until now, options for these components were limited to glass

5 medtech funding insights you need to know

Venture capital funding isn’t what it used to be for medical device startups, but there are actually reasons to feel optimistic about medtech funding. That was the big takeaway from a four-expert panel at DeviceTalks Minnesota last month. (The next DeviceTalks is Oct. 2 in Boston.) Charlie Whelan, director of transformational health consulting at Frost & Sullivan,

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Here are the top 5 medtech stories of mid-2017

The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from

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Two Supreme Court decisions take a whack at patent holders

Landmark U.S. Supreme Court decisions signal an effort to shoot down patent trolls, but one expert says small business could get caught in the crosshairs. Recent Supreme Court decisions dealing with patents have some experts concerned that, rather than clarifying the rules and combating patent trolls, the rulings will instead weaken the rights of patent

When designing medical devices, consider the hands

Heather Thompson and Chris Newmarker Our hands are the emotional and physical link to our environment. They are also the link to our brain. “What I try to tell people is how complicated the hand is,” Bryce Rutter, founder and CEO of Metaphase, told MDO this week at MD&M East in New York. Rutter is

Check out this global robotic surgery event

Starting on June 15, at 8 am (GMT), check out the fifth worldwide 24-hour robotic surgery event. The live event, hosted by the Worldwide Robotic Surgery Education (WRSE), incorporates 15 surgeries from leading robotic centers on four different continents. The roving studio features presentations, masterclasses, and expert-led discussions. Dr. Peter Wiklund is a member of

Medtech product management: 3 popular strategies for developing hardware

In medtech, project managers struggle with project complexity, and unknowns. Once you start adding complexity and unknowns to the project, you will need a paradigm that properly fits the project at hand. Product Creation Studio recently released a video on 3 project management strategies and offers some advice on what might work best for medical technology hardware product

FDA announces regulatory updates under 21st Century Cures Act

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

Abbott heart device shown safe for infants

Developing very small devices that can be used for children is a significant challenge in the market. FDA is cautious to approve new devices into this market for vulnerable patients. But the efforts are needed to improve the health of babies, particularly those born with heart defects. Abbott’s reduced sized Amplatzer duct occluder II (ADO

Mind-controlled device can help stroke patients move paralyzed hands

A mind-controlled device fitting over paralyzed hands could enable stroke patients to open and close them once again, according to research from the Washington University School of Medicine in St Louis. analyzed the use of Ipsihand, developed by Neurolutions Inc. The researchers analyzed the use of Ipsihand, developed by Neurolutions. The brain-computer interface helps participants

Thinking about wading into robotic surgery? We’ve got some 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

4 steps to deeper medical device design insights

When it comes to medical device design insights, Karten Design might have a helpful tool with its “Voice of the Ecosystem” approach. There are many changes to the healthcare system, Eunji Park, lead design strategist at Karten Design, explained during a webinar this week entitled, “Unpacking the Ecosystem of Healthcare Consumers.” Cost increases in the healthcare