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| Vol. 15 No. 11, May 30, 2018 |


Medical Device Recalls Highest Since 2005
More medical devices were recalled in the first quarter of this year than any time since 2005, according to according to the latest U.S. Recall Index that also says prescription drug recalls increased.
There were 343 device recalls in the first three months of the year, an increase of 126 percent over the last quarter of 2017, according to the report from data company Stericycle Expert Solutions. There were 105 prescription drug recalls, an increase of 52 percent and the highest number since 2013.
The total number of medical device units recalled in the quarter was about 208.4 million, with the average number involved in each recall being 607,512, according to the report. The vast majority of the units – 93.7 percent – were recalled due to manufacturing defects.  Software problems were the top cause for the recalls. A total of 22.7 percent of recalls were for that reason. It was the eighth quarter in a row that software was the top reason for device recalls.


Former Canada Health Infoway CTO Joins Startup that Aims to Finally Take Health Records Digital
Dennis Giokas is joining MedChart through MaRs Embedded Executive Funding program, after 14 years as the chief technology officer at Canada Health Infoway, the crown corporation that has been working on the implementation of electronic health records with the provinces. Giokas is looking to tackle the problem from a different angle. MedChart seeks to put the power of the medical chart back in the hands of the patient. Canada’s health laws already make clear that the individual owns their data and can request it from their healthcare providers at any point, but in practice that is rarely done. MedChart seeks to simplify the process. Individuals sign up and give MedChart permission to collect their information on their behalf, and MedChart pulls together the data from multiple healthcare providers into a centralized online portal that patients can visit and manage as they see fit.


Medical-Device Companies Say New Safety Rules Will Boost Costs, Force Some Companies Out of Canada
Medical-device companies say new safety audit rules from Health Canada will send compliance costs skyrocketing, forcing some players to pull out of the country and creating a potential shortage of products for patients. The Medical Device Single Audit Program (MDSAP), which becomes mandatory on Jan. 1, 2019, is expected to cost some companies thousands of extra dollars in auditing fees. The makers of devices such as oxygen masks, surgical equipment and medication-delivery systems say they’ve been quoted fees of $30,000 to $50,000 annually for an audit that used to cost between $3,000 and $5,000 a year.

Nextstim's NBT Transcranial Magnetic Stimulation Coming to U.S. to Treat Major Depression
Nextstim, based in Helsinki, Finland, is making its NBT Navigated Brain Therapy system available in the U.S. for treatment of Major Depressive Disorder. The device is used to deliver transcranial magnetic stimulation to the brain, a therapy that has shown to be effective for certain patients.
The system consists of the transcranial magnetic stimulator, stimulation coil, a stereo camera that’s used for tracking the location of the patient with respect to the coil, an electromyograph, computer and accompanying software, display, and a few other odds and ends.


Chinese Medical Devices Maker Forays into Indian Market
China-based Lepu Medical Technology (Beijing) Co. Ltd today said it is all set to make its foray into Indian medical devices and equipment market through its subsidiary, Lepucare (India) Vascular Solutions Pvt. Ltd. According to a press release issued by the company, it is the fifth overseas subsidiary of the Chinese manufacturer, globally. 
Established in 1999, Lepu Medical specialises in developing, manufacturing and distribution of high-tech medical devices, equipment, mobile medical services and pharmaceuticals.
Lepu Medical vice president, Aaron Lin saidIndia had grown into one of the prime markets for medical devices and equipment adding the demand here will far outstrip that of the current leading markets in America and Europe.

U.K. Makes it Harder for Officials to Get Patient Data
Britain's government says it has modified a controversial data-sharing agreement that allowed officials to track down people who might have broken immigration rules based on information collected by doctors. The agreement had previously granted the government permission to seek details on people if there were questions about their immigration status, an arrangement slammed by British medical organizations as a violation of doctor-patient privilege.
The Home Office said information would only be collected for people being considered for deportation and who were convicted of a serious crime.


Canada Health Infoway Teams up with Kids Help Phone to Provide Crisis Support Via Text
Canada Health Infoway (Infoway) and Kids Help Phone have formed a partnership to help expand the reach of Crisis Text Line powered by Kids Help Phone.
In January 2018, Kids Help Phone — the only nationwide counselling and support service of its kind for youth in Canada — formed a service partnership with U.S. based helpline and technology pioneer, Crisis Text Line, to provide people in Canada with the first ever, 24/7, free nationwide crisis texting service. A pilot introduction of Crisis Text Line powered by Kids Help Phone began in Manitoba in February and the service will be rolled out to other provinces and territories in English and French later this year.

Novari eReferral Technology First to Go Live in Ontario for MSK Patients
Kingston, Ontario's Novari Health’s eReferral and central intake technology has gone live in the North West and Central LHIN regions of the province.  The 14 Local Health Integration Networks have been mandated to implement a central intake and rapid clinical assessment model of care for patients being referred for possible hip or knee replacement surgeries.  To efficiently and economically meet this provincial access to care requirement, most LHINs are deploying eReferral and central intake enabling technologies.  Novari Health, a long-standing leader in this area, has been engaged in much of the province to deploy the Novari Access to Care® software platform and specifically the Novari eRequest® module.


Canada's Top Science Prize Won by Researcher Who Spies on Shape-Shifting Proteins
Lewis Kay, a Toronto researcher who developed a technique to watch microscopic proteins reposition themselves and change their shapes within cells, has won the $1 million Herzberg Gold Medal, Canada's top science prize. Kay, a professor of biochemistry at the University of Toronto and a senior scientist at the Hospital for Sick Children, has spent his career improving nuclear magnetic resonance spectroscopy, the technology behind the MRI scans used for medical imaging of the human body. But Kay uses it to look at things on a much smaller scale, to see how proteins shape-shift and move in ways that change what kinds of things they can do within the human body — including causing disease.

National Competition Launched to Identify Innovative Ideas to Support Healthy Aging
Canadians are being invited to take part in a national competition that will identify great new ideas to support healthy aging.
The AGE-WELL National Impact Challenge is looking for new and unique technology-based solutions that can benefit Canadians as they age.
Contestants will compete for prizes totalling over $100,000 in cash and in-kind services by showcasing how their solution could positively impact older Canadians or their caregivers.
Hosted by AGE-WELL, Canada's Technology and Aging Network, the competition was announced yesterday in Ottawa by Bill Blair, Parliamentary Secretary to the Minister of Justice and Attorney General of Canada and to the Minister of Health, at AGE-WELL Day on the Hill.


DeviceTalks Minnesota June 4-5, 2018 - Saint Paul, MN
DeviceTalks is the premier industry event for the medtech community fostering the exchange of ideas, insight and technology among the pioneers of the medical technology industry and the engineering behind it.

MedTech Summit June 11-15, 2018 - Brussels, Belgium
EU MDR & IVDR: THE RACE IS ON. Including Clinical Strategies, PMS & Vigilance, Combination Products, Sterilisation, and Emerging Markets Requirements
The Medical Device R&D Summit Spring June 28-29, 2018 - Las Vegas, NV
The conference will cover areas like the Summit offers an intimate environment for focused discussion on cutting-edge technology, strategy and implementation of solutions to forward-thinking medical device companies interested in staying ahead of the market.


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