A $12 million settlement agreement was reached by Medtronic with Washington, California, Massachusetts, Illinois and Oregon to resolve claims that it promoted its Infuse bone graft product for spinal surgery using deceptive company-sponsored scientific literature. The company did not admit to any wrongdoing and, according to a company spokeswoman, nothing in the agreement can be considered as concession or admission of the allegations.
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A round of funding brought in approximately $1.48 million for UK-based Abingdon Health. The proceeds will be used as working capital, as well as to continue the extension of the company's lateral flow device products and related reader systems, such as the Seralite rapid test for diagnosis and management of multiple myeloma patients.
Millar, a medical device and original equipment manufacturing company, entered into a deal to sell its life sciences telemetry product division to New Zealand-based Kaha Sciences. The divestiture, which is expected to close by the end of the year, comes amid the company's strategic plan to concentrate on the clinical and OEM business segments.
An exclusive agreement was signed by Elekta, making Brainlab the authorized distributor of its stereotactic neurosurgery solutions, including the Leksell Vantage stereotactic system, in the US. The agreement expands on the companies' European Union distribution agreement reached in June.
A Meddevicetracker report predicts the worldwide market for transdermal drug delivery devices will hit $8.1 billion by 2021 with a 2.9% compound annual growth rate. The largest growth, at 3.6%, is expected to come from the neurological disorder segment, the second-largest segment after pain management, while a slightly smaller growth in the 2% range will be seen in the cardiovascular disease, hormone replacement therapies and genitourinary disorders segments.
A report on patient-reported outcomes from medical device use was released by the FDA's Center for Devices and Radiological Health, outlining its steps in meeting the data increase and the data-handling education and training it provides to the agency's staff members. The agency saw a significant increase in the amount of patient-reported outcomes data it receives, with such data included in over 80% of investigational device exemptions this year.
The teamplay Cardio dashboard application was unveiled by Siemens Healthineers within the Digital Ecosystem platform. The application provides insight into the cardiology department's resources, performance and status by analyzing data from non-DICOM and DICOM sources.
Xenco Medical announced the launch of its on-demand trauma surgery delivery app, TraumaGPS. The app, which enables GPS tracking of the company's sterile-packaged spinal implant systems on a mobile map in real time, allows emergency delivery of the systems to be requested by users.
Vertex Pharmaceuticals' cystic fibrosis drug Kalydeco is a success story that is difficult to replicate for Alzheimer's disease, diabetes and other complex conditions, due in part to misplaced incentives and an inadequate drug development system, writes David H. Freedman, co-founder of Global HealthCare Insights. The scene is changing, though, as the government, academia and the drug industry refocus on basic research and collaboration, Freedman writes. And if a drug as successful as Kalydeco comes along to treat a more common condition, if similarly priced, there wouldn't be "enough money in the health care bank to give drugs at those prices to everyone who will need them," said Bernard Munos, a senior fellow at FasterCures.