Diagnostic

Passing the painstaking standards for multilingual medical device labeling is tough. Achieving this requires accurate translation, localization, testing, and validation. The key, of course, is advanced planning and thorough preparation.  Translation for medical device content is particularly more demanding than it is for other sectors. It doesn’t just require quality assurance review to make sure
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Accuray had a strong showing at the American Society for Radiation Oncology annual meeting and touted the effectiveness of its technology against competitors. The Sunnyvale, CA-based company said a study published in Frontiers in Oncology found early-stage breast cancer patients could experience significant improvements in survival if treated with accelerated partial breast irradiation (APBI) delivered
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An advisory panel on general and plastic surgery voted against recommending FDA approval of Integra LifeSciences’ SurgiMend mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for more than a decade under a 510(k) clearance. A specific indiation for breast reconstruction — which no device currently has — would have
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Maybe it’s because Halloween is upon us, or maybe it’s because I’ve been binge-watching The Walking Dead: World Beyond, but lately I’ve had Zombies on the brain. Several years ago, a team of Cornell University researchers used statistical mechanics and techniques used in modern disease modeling and critical phenomena to explore how a zombie outbreak might spread across
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A 3D-printed polymer-based implant that could be used to repair a damaged eardrum is entering commercial development. The PhonoGraft hearing-restoration technology was developed by researchers at Harvard’s Wyss Institute for Biologically Inspired Engineering, Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), and Massachusetts Eye and Ear (MEE). If clinical development of the technology
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With its latest proposed acquisition, 23andMe could get into one of the fastest growing markets in healthcare – telemedicine. The consumer genetics company said it signed a definitive agreement to acquire  Lemonaid Health, an on-demand platform for accessing medical care and pharmacy services online, for $400 million. About 25% will be paid in cash and 75%
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Why Did J&J Delay Ottava? The development of — Ottava, a robotic-assisted surgical solution that Johnson & Johnson has been talking up for a while now — has been delayed by about two years. J&J said it has encountered technical development challenges and COVID-19 related disruptions, including supply chain constraints being experienced broadly across all industries. Last year,
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For years Intuitive Surgical has been at the forefront of the surgical robotics market with its da Vinci platform. However, the competitive landscape changed when Medtronic won CE mark for the Hugo Robotic Assisted Surgical device. Executives from the Sunnyvale, CA-based company openly-addressed the competition in the robotics market this week during a 3Q21 earnings.
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In recent weeks, Needham & Co.’s team of medtech analysts met with a series of investors across several regions of the United States. We previously shared their insights on AtriCure, Haemonetics, NuVasive, LivaNova, and Globus Medical. Conmed was also among the most frequently asked about companies during those conversations, according to a report from Needham’s Mike Matson, David Saxon, and Joseph Conway.
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JP Morgan’s Robbie Marcus teed it up nicely during the question-and-answer portion of Abbott’s third-quarter earnings call when he asked CEO Robert Ford a critical question related to the COVID-19 pandemic. Ford’s response includes valuable lessons from the pandemic that could ultimately be beneficial to the medtech industry at large. “I feel like you have a
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The medical device industry continues its growth streak, despite the COVID-19 pandemic. In 2020 the medtech market grew 6.3%, hitting a fourth consecutive year of growth, according to EY’s 2021 Pulse of the Industry report. And 94% of medtech companies are already reporting a better 2021 over 2020, according to EY. Some of this growth
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One of the biggest stories coming out of Johnson & Johnson’s earnings isn’t necessarily the impact of its single-dose COVID-19 vaccine. Yes, the vaccine did contribute to $502 million in revenue – but perhaps one of the biggest takeaways from the New Brunswick, NJ-based company’s 3Q21 earnings is the continued success of its once beleaguered
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What if an infusion pump, IV drip, or medical cart could help prevent medical errors and streamline patient billing? With radio-frequency Identification (RFID) of consumables, operators, and patients, they can. An RFID system that identifies both people and product could enable device manufacturers to improve the safety and security of their systems, protect revenue streams
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In recent weeks, Needham & Co.’s team of medtech analysts met with a series of investors across several regions of the United States. We previously shared their insights on AtriCure, Haemonetics, NuVasive, and LivaNova. Globus Medical was also among the most frequently asked about companies during those conversations, according to a report from Needham’s Mike Matson, David Saxon, and Joseph
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Risk management has been a popular topic given expectations in the new European Medical Device Regulation (MDR). But regulatory compliance shouldn’t be the main driver. Medical device manufacturers should manage risks methodically during each stage of the design and manufacturing process, including the concept level, according to Perry Parendo of Perry’s Solutions LLC. The benefits
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