Medical Device Industry News

Sales, earnings plunge for Intuitive Surgical during dreary Q1

April 22, 2014 by Brian Johnson

Intuitive Surgical sees shares slump in after-hours trading after posting dreary sales and earnings numbers for the 1st quarter of 2014.

Intuitive Surgical drops on Q1 prelims

Intuitive Surgical (NSDQ:ISRG) said sales dropped nearly 24% during the first 3 months of 2014, missing analysts' estimates and sending shares down 4% in after-hours trading.

MassDevice.com +3 | The top 3 medtech stories for Apr. 22, 2014

April 22, 2014 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 clears Intuitive Surgical's single-site da Vinci Sp robotic surgery system

April 22, 2014 by Brad Perriello

The FDA grants 510(k) clearance to Intuitive Surgical's da Vinci Sp single-site robotic surgery platform, sending ISRG shares up on Wall Street.

FDA approves Intuitive Surgical's single-site da Vinci Sp robotic surgery system

Intuitive Surgical (NSDQ:ISRG) shares recouped some recent losses today after the medical device company announced 510(k) clearance from the FDA for its da Vinci Sp single-site robot-assisted surgery platform in urological procedures.

FDA floats expedited approval for unmet needs

April 22, 2014 by Brad Perriello

The FDA proposes an expedited pre-market approval program for high-risk medical devices that address unmet needs.

FDA floats expedited approval for unmet needs

The FDA today proposed a new regulatory option for high-risk medical devices that address unmet needs, aiming to speed access to the devices for patients.

Ethicon fights plaintiffs' remand bid in pelvic mesh cases

April 22, 2014 by Brad Perriello

Johnson & Johnson's Ethicon subsidiary fights a move to have pelvic mesh product liability lawsuits remanded to a Pennsylvania state court.

Ethicon fights plaintiffs' remand bid in pelvic mesh cases

Johnson & Johnson's (NYSE:JNJ) Ethicon subsidiary asked a federal judge yesterday to block a bid to send a group of pelvic mesh product liability cases back to a state court in Philadelphia.

K2M's IPO could reap as much as $183M

April 22, 2014 by Brad Perriello

K2M says its forthcoming initial public offering could garner as much as $183 million, if its underwriters exercise a 1.3 million-share over-allotment.

K2M's IPO could reap as much as $183M

K2M Group Holdings, the largest privately held spinal implant maker, said today that its forthcoming initial public offering could be worth up to $183 million.

K2M announced its plans for a U.S. IPO early this year, saying in March that the launch could be worth $100 million.

Medline nabs Amendia's cervical spinal surgery tech in closed-doors deal

April 22, 2014 by Arezu Sarvestani

Medline Industries acquires spinal surgery technologies from Amendia, with few details made public about the grab.

Medline nabs Amendia's cervical spinal surgery tech in closed-doors deal

Illinois-based Medline Industries acquired key spine surgery technologies from Georgia-based Amendia, the companies announced this month.

Medline nabbed Amendia's anterior cervical fusion distraction pin business, part of a market that Medline expects to grow more than 8% annually. The technologies are used in surgeries for removing problem disks in the neck area of the spine.

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