Medical Device Industry News

FDA warns Smith & Nephew on Truclear Ultra morcellator

May 6, 2015 by Brad Perriello

The FDA sends a warning letter to Smith & Nephew after inspections turn up problems with a version of its Truclear Ultra laparoscopic power morcellator.

FDA warns Smith & Nephew on Truclear Ultra morcellator

MassDevice.com +3 | The top 3 medtech stories for May 6, 2015

May 6, 2015 by MassDevice

Plus 3

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.

 

FDA withdraws older guidance documents

May 6, 2015 by Mark Hollmer

The FDA pulls 47 draft guidance documents it never made official, covering medical devices, diagnostics, pharmaceuticals and more.

FDA withdraws older guidance documents

The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on.

Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents.

Sorin hopes Perceval valve will rescue flat results

May 6, 2015 by Mark Hollmer

Sorin reported flat results for Q1, but sees expected FDA approval of its Perceval sutureless aortic valve as helping to accelerate growth in the 2015 second half. Results from three new studies of the implant underscore its potential market potential.

Sorin hopes Perceval valve will rescue flat results

Coloplast tumbles on missed Q2 expectations

May 6, 2015 by MassDevice

Coloplast shares tumble nearly 4% after the Danish medical device company misses expectations with its fiscal 2nd-quarter profits.

Coloplast tumbles on missed expectations

(Reuters) — Coloplast (CPH:COLO B) reported a 16% increase in 2nd-quarter core profit, slightly below expectations, pushing the medical device company's share price down nearly 4%.

Transcend Medical touts data, plans FDA filing for CyPass glaucoma stent

May 6, 2015 by Brad Perriello

Transcend Medical touts positive data from a clinical trial of its CyPass micro-stent for treating glaucoma, saying it plans to file for pre-market approval from the FDA this year.

Transcend Medical touts data, plans FDA filing for CyPass glaucoma stent

EndoChoice files for $115m IPO

May 6, 2015 by Brad Perriello

Endoscope maker EndoChoice, fresh off a $57 million funding round, registers for an initial public offering worth $115 million.

EndoChoice files for $115m IPO

EndoChoice said today that it filed for an initial public offering that could fetch as much as $115 million, scarcely 2 months after pulling down a $57 million funding round for its Fuse full-spectrum endoscope.