Abbott Laboratories' acquisition of St. Jude Medical, valued at $25 billion, has obtained approval from the European Commission on the condition that Abbott will sell two cardiovascular treatment devices. Abbott has committed to divest its Vado business and the global vessel closure devices business of St. Jude Medical to address the commission's competition concerns.
Why Platform Matters When Choosing an ERP System In order to survive, grow, and compete in the digital age, organizations need an ERP that is highly flexible and able to adapt. So, what are the tough platform questions you should ask yourself when shopping for an ERP? Download the report to find out!
Zimmer Biomet has partnered with the Indo UK Institute of Health to enhance patient access to affordable musculoskeletal health care in India under the institute's Medicity program. The 20-year collaboration calls for Zimmer Biomet to provide and distribute large joint implants, trauma products and small fixation devices for replacement surgery, as well as to invest in IUIH's parent company, UK Global Healthcare Limited.
Brady Shirley, the former president of surgical business at DJO Global, has been tapped to serve as president and chief executive officer at the company. Shirley will replace Mike Mogul, who will stay in his post until the end of the year.
Oystein Valberg, who has over 20 years of experience in corporate finance, has been tapped to serve as chief financial officer at Oakland, N.J.-based Collagen Matrix. Valberg previously served as chief financial officer and vice president of finance, strategy and business development at Medtronic's surgical technology business unit.
A 900-patient study presented at the American Heart Association's Scientific Sessions showed positive results for HeartLogic, a system of sensors developed by Boston Scientific for tracking vital signs, connecting to defibrillator devices and providing doctors with alerts on symptomatic patients. Researchers from the Penn State College of Medicine reported that the system detected 70% of heart failure events at about 34 days before an event, with the number of false positives occurring within "an acceptable range."
European regulators have given Exact Imaging CE mark approval for its ExactVu micro-ultrasound platform for prostate imaging and biopsy guidance. The device comes with an operating frequency of 29 MHz and provides real-time, high-resolution imaging of the prostate, allowing for improved biopsy performance and enhanced viewing of abnormalities.
Republican leaders in Congress said they have reached an agreement on the 21st Century Cures Act, which contains provisions that would expedite FDA review of breakthrough medical devices and drug-device combinations, among others, and now expect the bill to be approved by year's end. A Senate health committee senior aide, however, said Senate Democrats are still negotiating and hope to make changes to the legislation, which will be up for vote in the House on Wednesday.
Belgrade, Mont.-based Xtant Medical has obtained clearance from the FDA for its Xsert Lumbar Expandable Interbody System, a titanium expandable interbody device intended for facilitating insertion techniques while offering implant height adjustability. The device, which comes in various sizes and lordotic angulations, is cleared to be used with allograft bone graft or autograft.
Abbott has obtained emergency use authorization from the FDA for its RealTime Zika assay, which is intended for the detection of Zika RNA in human serum, urine and EDTA plasma. The RT-PCR assay allows nucleic acids to be isolated from a sample and be purified using the Abbott mSample Preparation System that runs on an authorized instrument, such as the Abbott m2000sp instrument.
Nov. 29 | Washington, D.C. Over the course of this one-day event, you'll hear from FDA and industry experts and participate in a cyber war game. You'll walk away with a better understanding of how industry leaders work to secure their devices and manage cyber risks, as well as the legal, PR and other impacts of a cybersecurity incident. Learn more.
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