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Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research. How wearable devices are advancing medicine Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 12, 2017
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. Get this in your inbox everyday by subscribing to our newsletters.   5. Xtant Medical amends Orbimed credit line to $15m, taps restructuring advisors Xtant Medical said today that it amended its senior credit line with OrbiMed Advisors, saying it plans to use the $15 million facility to pay off the ...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 8, 2017
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. Get this in your inbox everyday by subscribing to our newsletters.   5. Court clears Caldera’s $12.3m transvaginal mesh settlement A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transv...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
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. Get this in your inbox everyday by subscribing to our newsletters.   5. Toshiba partners with UCI to study potential brain damage in HS football players Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news