Sunlamp products & UV Lamps: 3 months to submit 510(k)s to FDA
By David Lennarz, Vice President and Co-Founder of Registrar Corp
PureTech seeks $160m in U.K. listing
(Reuters) — Boston-based PureTech Health plans to raise $160 million in a London listing, filling its coffers to fund product development and delivering a vote of confidence on the British life sciences sector.
The move by the U.S. health technology firm follows a similar decision by California-based drug discovery group Verseon to raise $100 million in London earlier this month.
MassDevice.com +3 | The top 3 medtech stories for May 22, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
Substantial medical device review fee increases at Taiwan Food and Drug Administration
By Stewart Eisenhart, Emergo Group
Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.
Mind-controlled prosthetic limbs allow precise, smooth movement
(Reuters) — More than a decade after becoming paralyzed from the neck down, Erik Sorto has been unable to perform even the simplest of daily tasks.
Shockwave Medical raises $40 million for its ‘lithoplasty’ system | Medtech funding for the week of May 18, 2015
21st century cures act
MassDevice.com +3 | The top 3 medtech stories for May 21, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
Seven mistakes that can delay your FDA 510(k) clearance
By Stewart Eisenhart, Emergo Group
Based on data provided by the US Food and Drug Administration as well as Emergo consultants’ experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been identified as the most common perennial causes for delayed premarket notification applications.
MassDevice.com +3 | The top 3 medtech stories for May 20, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
