J&J, Apple partner on heart health study | Turkey postpones $10B medtech tender for 4th time | HighLife gets $36M-plus boost
January 18, 2019
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News for medical technology professionals
Top Story
J&J, Apple partner on heart health study
Johnson & Johnson and Apple have teamed up to conduct a multiyear study starting this year to assess the efficacy of the Apple Watch, along with J&J's heart health monitoring app, in detecting irregular heart rhythms. "The goal is to identify early on [atrial fibrillation] and prevent stroke by combining the physical know-how from Apple and what we have from the medical and scientific know-how," said Paul Stoffels, Johnson & Johnson's executive vice president and chief scientific officer.
USA Today (1/18),  The Wall Street Journal (tiered subscription model) (1/17) 
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Business & Market Trends
Turkey postpones $10B medtech tender for 4th time
The Turkish government has rescheduled for the fourth time its planned $10 billion medtech tender for MR screening devices, ultrasonography devices, patient monitoring systems, computed tomography devices and digital radiography devices to April 16. The tender was previously scheduled to take place Jan. 10.
Medtech Insight (free registration) (1/17) 
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HighLife gets $36M-plus boost
A round of Series B financing has pulled in $36.4 million for Paris-based transcatheter mitral valve replacement maker HighLife. The proceeds will be used to conduct a US feasibility trial and complete trials for securing CE mark approval from European regulators.
MassDevice (Boston) (1/17) 
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Bridging round brings in $11.5M for Itamar Medical
A private bridging placement has generated $11.5 million in proceeds for Itamar Medical, which makes a system for home diagnosis of sleep breathing disorders. The company also plans a US public offering.
Globes (Israel) (1/17) 
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Funding round pulls in $4.4M-plus for OtoNexus
A round of financing has brought in over $4.4 million for OtoNexus Medical Technologies, bringing the company closer to its goal of almost $8.3 million, a filing with the Securities and Exchange Commission showed. The company, whose funders and supporters include AdvaMed, is developing a device that helps diagnose middle ear infections using air-coupled ultrasound technology.
Medical Design & Outsourcing (1/17) 
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Japanese Red Cross, Abbott sign exclusive blood screening supply deal
Abbott has been selected by the Japanese Red Cross Society to provide serological instrumentation, assays and consumables to be used for blood and plasma screening through an exclusive eight-year contract. The parties did not disclose any further information on the terms of the deal.
360Dx (tiered subscription model) (1/17),  Medical Design & Outsourcing (1/17) 
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Science & Health
Medtronic enrolls first patient in study of SynchroMed II
Medtronic has enrolled the first participant in a study of the SynchroMed II intrathecal drug delivery system. The study, which will include 100 patients, aims to evaluate the use of the system as an alternative to oral opioids for patients with chronic intractable nonmalignant primary back pain.
Drug Delivery Business News (1/17) 
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Emerging Technologies
Wearable device studied for detection of pediatric anxiety, depression
Researchers used a common wearable movement sensor to measure physiological responses of 63 children ages 3 to 7 to a 90-second mood induction task with the goal of detecting internalizing disorders, including depression and anxiety. The study, published in PLOS ONE, found that performing a machine learning algorithm-based analysis of just 20 seconds of movement data had an 81% accuracy rate in identifying children with internalizing disorders.
Mashable (1/17),  New Atlas (1/17) 
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Government & Regulatory
FDA opens investigation into paclitaxel devices for PAD
The FDA has issued a letter to health care providers alerting them of an investigation into paclitaxel-coated and paclitaxel-eluting devices designed for treating peripheral artery disease in the legs after a review in the Journal of the American Heart Association linked use of these devices with increased all-cause mortality risk. Spokespeople for Boston Scientific and Medtronic both noted that the meta-analysis did not consider patient-level data and maintained that the companies' devices were safe.
Star Tribune (Minneapolis-St. Paul, Minn.) (tiered subscription model) (1/17) 
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FDA clears staple system from Gramercy
The FDA has granted Gramercy Extremity Orthopedics clearance to market its Nitinol staple system for use in treating patients with bone-related conditions. The system is indicated for joint fusion surgery and fixation of small bone fragments and osteotomies.
FDAnews (1/18) 
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AdvaMed Events and Education
Recalls from A-Z Workshop
April 16-17, 2019
During this workshop you'll establish a clear understanding how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts. Register here.
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