A $74 million manufacturing plant for surgical devices will be built by Arthrex in Anderson County, S.C., and the project is expected to bring 1,000 jobs to the area over five years. A more than 40-year deal with the county, valued at over $12.9 million if all commitments are met, would provide the company with performance-based incentives, including property-tax discounts, with some as high as 90 percent for 10 years.
The possibility of Britain exiting from the EU without a trade agreement has prompted medical device and pharmaceutical companies to draw up plans for protecting their supply chains. "Everybody is planning and regretting the fact they didn't start planning earlier," said Neil Armstrong, CEO of medtech regulations-focused consultancy firm MeddiQuest, which is now helping global companies draft their contingency plans and is itself working to relocate from the UK to Ireland in order to remain an EU-authorized representative.
A placement of shares has brought in the equivalent of about $3.1 million for Neurotech International, an Australian medtech company that makes a clinical-quality electroencephalography device called Mente Autism for treating autism spectrum disorder using neurofeedback. The company intends to use the proceeds for product enhancements and additional inventory purchase and manufacturing, as well as to assess potential strategic activities.
A Vennli study found that about two-fifths of more than 9,000 health care providers surveyed think medical device brands are not performing up to their expectations. Ninety-four percent of the providers said consistent outcomes are a significant factor to consider when choosing the right device to purchase, while flexible contract options and being recommended by a key opinion leader are important to more than 80% and 62% of respondents, respectively, among other key findings.
A strategic partnership agreement has been reached by Medtronic Care Management Services and American Well to provide complex, chronic and co-morbid populations with telehealth services to improve patient outcomes and reduce cost of care. The deal will allow for remote patient monitoring through the integration of American Well's telemedicine services into Medtronic's MCMS video-enabled platforms in order to improve patient access.
7 keys: Put real-world evidence into action Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
Historically, medical devices have been scary and unorthodox -- and sometimes amounted to outright quackery. For example, shoe stores back in the day had foot X-rays called fluoroscopes that basically were radioactive advertising gimmicks. Yes, colors can affect people's moods, but the early 20th-century Spectrochrome took things to an extreme level when it came to its creator's claims. On the opposite side of the spectrum, some true medtech innovators sometimes went to extreme lengths. Dr. C. Walton Lillehei -- a pioneering Minnesota heart surgeon -- turned to beer hoses and a dairy pump during the1950s as he tried to save a 14-month-old baby. Read the story.
Regence Blue Cross Blue Shield has issued a positive coverage decision for Thermo Fisher Scientific's Oncomine Dx Target Test, a next-generation sequencing-based companion diagnostic designed for simultaneous evaluation of 23 genes linked to non-small cell lung cancer. The decision makes the test available to the insurer's members in Idaho, Oregon, Utah and some Washington state counties.
A patient at Kantonsspital Baselland in Switzerland underwent the first implantation of REVA Medical's Fantom bioresorbable scaffold, which is designed for the treatment of coronary artery disease. The scaffold is made from the company's proprietary tyrosine-derived polymer, called Tyrocore, intended for vascular scaffold applications.
The Proclaim dorsal root ganglion neurostimulator system has been launched by Abbott for use in alleviating pain in patients who have complex regional pain syndrome of the lower limbs. The system, which is magnetic resonance-conditional and recharge free, is intended to be used with an Apple iPod touch as a system controller via Bluetooth connectivity.
The FDA has given NuVasive expanded clearance for its TLX interbody system, which is designed for use in transforaminal lumbar interbody fusion. The system, which comes in a low-profile, bulleted design, can now be used in the thoracic spine and at the thoracolumbar junction for the treatment of disc degeneration disease or degenerative spondylolisthesis at up to two adjacent levels.
The FDA has granted Stryker 510(k) clearance for its cementless Mako Total Knee with Triathlon Tritanium. The company's Triathlon knee implant comes with tibial baseplate and metal-backed patellar components, and has been enhanced with biologic fixation technology.
Oct. 24-25 | Washington, D.C. Whether you have recently taken on compliance responsibilities, are about to set up a new compliance structure, are in the midst of revamping your existing program or simply need a refresher, this course will provide you with a thorough understanding of the compliance framework and practical approaches for addressing challenges and effectively managing compliance in a medical device company. Learn more.
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