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. Monteris wins FDA IDE clearance for NeuroBlate trial
Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.
The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said. Read more
4. Report: Hospitals doubt medtech can help meet CMS outcome goals
While the Affordable Care Act could lead to improved partnerships between medtech manufacturers and hospitals, a new survey and report from ZS Associates indicates that hospital execs aren’t convinced that such partnerships will help them meet their needs.
The passing of the ACA has led to a shift in focus in the healthcare industry towards patient outcomes, which means that medtech companies will need to transition from serving merely as suppliers to becoming partners with hospitals, according to the report. Read more
3. EmboMedics raises $4.3m for embolization microbeads
EmboMedics said it raised a $4.3 million Series A1 round for the bioresorbable embolization microspheres it’s developing.
Maple Grove, Minn.-based EmboMedics said it plans to use the proceeds to pursue pre-market approval for a drug-delivery device, co-founder & CEO Omid Souresrafil said in prepared remarks. The infusion is enough to carry the company through 2018, Souresrafil said. Read more
2. Abbott prevails in 10-year-old stent lawsuit
A 10-year-old whistleblower lawsuit filed by a former Abbott sales rep, over the alleged off-label marketing of biliary stents, ended yesterday when a Dallas jury found for Abbott.
Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson and Boston Scientific in 2006, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing the lawsuit, Judge Barbara Lynn of the U.S. District Court for Northern Texas, later let J&J and Boston Scientific off the hook.) Read more
1. FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.
The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company. Read more
The post MassDevice.com +5 | The top 5 medtech stories for April 8, 2016 appeared first on MassDevice.
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