Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Orthofix launches study of pulsed electromagnetic fields in treating osteoarthritis
Orthofix said today it enrolled the 1st patient in a study exploring the use of its Physio-Stim pulsed electromagnetic field system for treating osteoarthritis of the knee.
The Lewisville, Texas-based company said the study aims to explore the efficacy and safety of its Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix to potentially provide symptomatic relief of osteoarthritis pain and stimulate new cartilage formation. Read more
4. Ethicon wins FDA nod for Enseal X1 tissue sealer
Johnson & Johnson subsidiary Ethicon said today it won FDA 510(k) clearance for its Enseal X1 large jaw tissue sealer designed for vessel sealing and precise heat management.
The Somerville, N.J.-based company said the newly cleared Enseal X1 is an advanced bipolar device designed for use in open procedures, such as colectomies and hysterectomies. Read more
3. Abbott touts 38% hypoglycemia reduction in FreeStyle Libre study
Abbott today released data from the Impact study of its FreeStyle Libre glucose monitor, touting significantly reduced hypoglycaemia in type 1 diabetes patients.
Data from the 328-patient trial was published in the journal Lancet, the company said. Read more
2. Insulet launches artificial pancreas feasibility trial for Omnipod Horizon device
Insulet said today that it’s launching a clinical trial of an artificial pancreas system based on its flagship Omnipod insulin management device for treating Type I diabetes.
The Omnipod Horizon automated glucose control system will link the Omnipod with continuous glucose monitoring technology from DXCM, Billerica, Mass.-based Insulet said. The 20-patient trial is designed to evaluate a “model predictive control” algorithm it acquired from a University of California-Santa Barbara spinout earlier this year. The software “looks toward the future horizon of blood glucose levels” to adjust insulin delivery, the company said today. Read more
1. FDA approves Medtronic’s In.Pact Admiral DCB for in-stent restenosis
Medtronic said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients.
The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty. Read more
