Medical Device Industry News

Anika's Q4 profits plunge

March 17, 2010 by MassDevice staff

Fourth-quarter profits for Anika Therapeutics fell 36 percent, despite and 18 percent revenue spike, but full-year 2009 sales and earnings both rise.

Anika Therapeutics Inc. (NSDQ:ANIK) saw fourth-quarter profits plunge 36.3 percent as it paid for an acquisition and the relocation of some of its manufacturing operations to its Bedford, Mass., headquarters.

Anika, which makes cosmetic and tissue-repair products using hyaluronic acid technology, posted net income of $697,000 (or 6 cents per diluted share) on revenues of $10.6 million during the three months ended Dec. 31, 2009. That compares with net income of $1.1 million, or 10 cents per diluted share, on revenues of $9 million during Q4 2008.

Covidien plans $1 billion share repurchasing

March 17, 2010 by MassDevice staff

Mansfield, Mass.-based medical products conglomerate Covidien could buy back as much as $1 billion worth of its own stock and will also pay out a quarterly dividend.

Covidien (NYSE:COV) is looking to repurchase about $1 billion worth of its own company stock and plans to kick out its usual 18-cent quarterly dividend to shareholders.

The Mansfield, Mass.-based medical equipment monolith said it will purchase up to $1 billion of its own stock, based on market conditions. Covidien added that it will institute a program to offset any dilution that could come from equity compensation plans.

UPDATE: Medtronic wins FDA nod for diabetes system, files for cryoablation PMA

March 17, 2010 by MassDevice staff

The Food & Drug Administration grants a supplemental PMA to the latest version of the MiniMed Paradigm REAL-Time system by Medtronic, which also files for a PMA for its Arctic Front cryoablation catheter system.

Medtronic Inc. (NYSE:MDT) won a supplemental PMA from the Food & Drug Administration for the latest version of its MiniMed Paradigm REAL-Time diabetes management system, which it touts as the "industry’s only integrated diabetes management system."

And the Fridley, Minn.-based medical devices monolith put another product into the PMA pipeline, its Arctic Front cryoablation catheter system, after revealing positive study results at a recent conference.

Cambridge Heart trims executive pay 10 percent, cede 2009 bonuses

March 17, 2010 by MassDevice staff

Cambridge Heart Inc.'s management agrees to a 10 percent paycut and no 2009 bonuses to help pare expenses for the cash-strapped cardiac monitor firm.

Top executives at Cambridge Heart Inc. (NSDQ:CAMH) agreed to 10 percent paycuts this year and will give up cash bonuses for 2009 as the money-poor manufacturer works to commercialize its cardiac monitoring tools.

The Tewksbury, Mass.-based company also eliminated per-meeting cash payments received by the three non-employee members on its board of directors and halved the $140,000 consulting fee it pays to its scientific founder. The reductions, approved March 11, should result in savings of at least $300,000 during 2010, with about a third of the extra funds resulting from the cuts in board compensation.

FDA questions Boston Scientific's expanded CRT bid

March 16, 2010 by MassDevice staff

A Food & Drug Administration panel says the Madit-CRT study was sound, but questions if the risk of implanting a device in patients with more mild heart failure is worth the benefit; final decision to come tomorrow.

A Food & Drug Administration panel said the risks of implanting cardiac resynchronization therapy defibrillators into patients suffering from milder forms of heart failure may not be worth the benefit on the open marketplace, even though Boston Scientific Corp. (NYSE:BSX) provided sound evidence of the devices' effectiveness in its Madit-CRT study last fall.

In materials released ahead of its March 18 meeting, the regulatory agency said that the Natick, Mass.-based medical device giant met the basic goals of the massive 1,800-plus patient study by proving that the company's therapy was effective in reducing heart failure events.

Abiomed hit with Class I recall

March 16, 2010 by MassDevice staff

The Food & Drug Administration orders a Class I recall of Abiomed's AB5000 heart support device, after receiving reports of computer problems causing it to lose power.

Abiomed Inc. (NSDQ:ABIO) was hit with a Class I recall of its AB5000 Circulatory Support System after receiving reports that the computer supplying power to the company's disposable heart pumps may shut down without warning.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products could cause serious injury or death.

Steris launches OR integration system

March 16, 2010 by MassDevice staff

Steris Corp. débuts a system to integrate operating room imaging technologies on a single touchscreen at the Assn. of periOperative Registered Nurses meeting in Denver.

By Mary Vanac

Mentor, Ohio-based Steris Corp. (NYSE:STE) launched a system that integrates operating room visualization technologies on a single touch-screen.

Introduced at the Assn. of periOperative Registered Nurses Congress in Denver, the Harmony iQ 2100 Integration System is a joint venture produced in tandem with VTS Medical Systems LLC of Melville, N.Y. It takes several units that control cameras, imaging devices and navigation equipment off a stacked tower or rack and consolidates them on one computer screen and microprocessor.