Given Imaging landed a win in Japan for its bite-sized pill camera used to detect colon disease. The PillCam Colon was cleared for sale this week by the island nation’s Pharmaceuticals & Medical Devices Agency and could expand the company’s Japanese market reach 10-fold, according to a press release.
Given Imaging
Ocular Therapeutix eyes a $24M Series D extension | Wall Street Beat
Ocular Therapeutix said it closed a $23.8 million Series D extension round from existing backers for its sustained drug release technology to treat eye diseases.
The Bedford, Mass.-based medical device company said all of its current institutional investors ponied up for the round, including Polaris Ventures, Versant Ventures, SV Life Sciences, Sparta LLC, and Ascension Health Ventures.
Ocular Therapeutix is developing a punctum plug for the entry of the tear duct to release drug therapy to the surface of the eye over several months.
St. Jude Medical seesaws on FDA warning letter
A warning letter from the FDA to St. Jude Medical (NYSE:STJ) sent the St. Paul, Minn.-based medical device company’s stock on a seesaw ride yesterday and today.
STJ shares closed up 1.5% yesterday at $38.85 each after St. Jude revealed the warning letter, but closed down 1.2% today at $38.39 apiece.
Given Imaging pursues FDA nod for its capsule endoscopy system
Given Imaging submitted for FDA approval its PillCam Colon 2 capsules endoscopy system, a device designed for the visualization of the colon.
The Israel-based company hopes to get the FDA nod through the federal watchdog agency’s de novo approval pathway.
Sign up to get our free newsletters delivered right to your inbox.
[sead]
Given imaging surges in Q3 net income; shares down
Given Imaging saw moderate growth in revenue during its 3rd quarter, and posted a 60% increase in net income.
The Israel-based medical device maker posted $6 million in profit, or 19¢ per share on sales of $45.4 million for the 3 months ended Sept. 30. That compared with a net income of $3.8 million, or 12¢ per share on sales of $44.7 million during the same period last year.
St. Jude Medical-backed Nanostim drums up $10M | Wall Street Beat
Nanostim, the Sunnyvale, Calif.-based company that’s developing a leadless pacemaker, raised $10 million in an equity and options deal, according to a regulatory filing.
NuVasive takes a shellacking on lowered guidance | Wall Street Beat
NuVasive Inc. (NSDQ:NUVA) shares are down more than 30% today after the medical device company said yesterday that its 3rd-quarter results are likely to be substantially lower than predicted.
San Diego-based NuVasive, which makes spinal surgery implants, said 3rd-quarter sales will be about $147 million, 4.8% below the roughly $154.4 million the company expected to post.
Medtronic wins expanded FDA indication for snoring implant | Regulatory Roundup
University of Michigan sues St. Jude Medical for breach of contract
The University of Michigan is suing St. Jude Medical (NYSE:STJ), accusing the medical device maker of failing to pay $4.3 million in royalties on sales of St. Jude’s Epic and Trifecta cardiovascular valves.