divendres, 10 de març del 2017

MassDevice.com +5 | The top 5 medtech stories for March 10, 2017

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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. Zoll Medical wins FDA PMA for Hospital Wearable Defibrillator

MassDevice.com news

Zoll Medical said today it won FDA premarket approval for its Hospital Wearable Defibrillator.

The Chelmsford, Mass.-based company’s HWD is designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation during hospital stays. The wearable device is designed to automatically detect and treat such events. Read more


4. FDA warns of contaminated organ preservation solution

MassDevice.com news

The FDA today warned of issues associated with contaminated SPS-1 static organ preservation solution from Organ Recovery Systems.

The solution is intended for the flushing and cold storage of the kidney, liver and pancreas at the time of organ removal from the donor to prep for storage, transportation and eventual transplantation. Read more


3. Court OKs IsoRay’s $3.5m settlement

MassDevice.com news

IsoRay said today that the US District Court for the Eastern District of Washington has approved a previously announced $3.5 million settlement related to a class action suit brought against it by shareholders last June.

The Richland, Wash.-based company faced putative class-action lawsuits from investors, accusing the company of making false or misleading statements about a clinical trial of its Cesium 131 brachytherapy seeds designed to treat cancer, according to a press release released last May. Read more


2. Report: Gottlieb is Trump’s top pick for FDA head

MassDevice.com news

Former FDA deputy commissioner Scott Gottlieb is the Trump administration’s top choice to head the agency, according to a Bloomberg report.

Gottlieb has held several senior positions at the FDA during the George W. Bush administration, and has regularly spoken on plans to lower prescription drug cost through modernizing the federal watchdog’s approval process, according to the report. Read more


1. Boston Scientific’s Connected Patient Challenge: Big data takes center stage

MassDevice.com news

Big data, artificial intelligence and patient-engagement technologies were among the systems featured at Connected Patient Challenge hosted by Boston Scientific at Google’s Cambridge, Mass. facility. Read more

 

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