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StarFish Medical May News: StarFish space at HTI Surrey BC; FDA reclassification candidates; YOLO LIPOFINA laser receives FDA clearance; LSBC Medical Device Breakfast Event; Schulich Innovation Research Day; #medicaldevices sightings and news
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Message from the President
Congratulations to Robert Krznaric, Lorenzo Lepore, and the entire team at YOLO Medical for receiving FDA 510(k) clearance of their LIPOFINA medical device. It's an exciting milestone for all medical device companies.
Hats off as well to Ryan D'Arcy and the team at Surrey Innovation Boulevard. It's exciting to participate in The Health Tech Innovation Hub. I'm confident we'll put this valuable resource to good use in the coming months and years.
I love seeing the energy continue to grow around commercializing medical devices. We're pleased to share information on medical device events and talks in Toronto, Vancouver, and Seattle throughout May and June.
Core competencies of a medical device project manager is the second blog from our PMO, Heidi Giesbrecht. It broke our record for LinkedIn shares and views in just two weeks. Paul Geyer's 15 rules also set a new record for click-through last month.
Christine Park, Industrial Designer, tackles Unleashing the impact of colour in medical device design. Her first segment focuses on trends and branding. I'm looking forward to the next installments as she brings insights from working with the colour experts at Belkin-- a leading consumer technology company.
In our new column of StarFish sightings, the first image is actually a music video. It's a clever rap created around the contest to choose a name for the StarFish star. What was the name? You'll have to watch to find out.
As always, thanks for reading.
Scott Phillips, President
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StarFish takes space at Health Tech Innovation in Hub Surrey BC
StarFish Medical sign greets visitors at HTI Open House April 9
StarFish Medical joins the Health Tech Innovation Hub at Surrey Innovation Boulevard adjacent to Surrey Memorial Hospital and SFU Surrey. The Health Tech Innovation Hub is a 22,000 square foot innovation space that aims to bring together universities, private businesses, clinicians and government in close proximity to facilitate advances in health-care research. It is a short walk from the King George sky train station.
"StarFish has worked closely with the medical device community of Greater Vancouver and Lower Mainland since our beginnings 16 years ago. We are glad to be part of this important initiative and look forward to using the space for easy-access interactions with clients, colleagues, and employees in the area," noted John Walmsley, StarFish Medical VP of Product, at the grand opening on April 9.
Unleashing the impact of colour in medical device design
By Christine Park
For almost a century, green was the colour of hospitals and medical devices. That's because back in 1914, according to a fascinating story in the Canadian Medical Journal, US surgeon Dr. Harry Sherman found the traditional white background much too bright and glaring under the new electric lighting systems.
Over a three-part blog series I will explore multiple aspects of colour design including trends and branding, functionality and emotional connection, and a process to help determine the best colours for your medical device.
StarFish Analysis: FDA lists 21 Class III products as reclassification candidates
By Rob Keur
In 2014 the FDA reviewed 69 percent of the class III product codes and recently listed 21 as candidates for reclassification to class II. The reduction in cost from a class III to a class II submission along with the reduction in ongoing post market costs means there will likely be a spike in submissions for many of these types of devices.
One of these is product code MYN, analyzer, medical image. To date this has been restricted to mainly mammography analysis software but this will probably be extended to other types of diagnosis as the reduced costs makes these products more viable.
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Client Update
LIPOFINA receives FDA clearance
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StarFish Sightings
#medicaldevices
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From the espresso bar
News that caught our eye
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YOLO Medical Inc., an industry leader in the manufacturing and distribution of medical and aesthetic devices, proudly announces that they have received FDA market clearance for YOLO's new generation body contouring laser system; LIPOFINA.
"The LIPOFINA laser will undoubtedly raise the bar in the market", states Robert J. Krznaric, CEO of YOLO Medical Inc.
Over the past 1.5 years, YOLO completed a randomized double blind controlled study to evaluate the effectiveness and safety of the LIPOFINA. The study results showed that a staggering 95% of subject that were treated with the LIPOFINA reached and surpassed the primary end point compared to 0% on the sham device (95% vs. 0%; P <.0001).
"We knew this device was special; the study result were statistically significant, validating all the hard work that was put into this laser over the past 4 years", states Robert J Krznaric.
"Now that we have clearance to market the LIPOFINA, our focus will be on launching this device and providing our customers with the most technologically advanced device in the market. Currently we are anticipating a launch date in the first quarter of 2016."
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A new precedent? Wearing a Fitbit could be the next step in health insurance discounts.
Microcoolers for microcomputers: How ‘tiny fluidics’ will cool your smartphone by 2017.
3D printed smart phone attachments are all the rage these days, but this DNA analyzer is actually worth checking out.
For “lab on a chip” devices to improve, the lasers that they use must improve. This laser is tuneable using a novel technology based on liquids.
Forget the needle: this sticky patch creates microabrasions for painless vaccinations without the possibility of cross contamination.
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© 2015 StarFish Medical Inc.
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