Here’s a roundup of the latest dealflow and investment news:
News Well
WEST taps Ilene Fischer for executive director | Personnel moves
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
Study: Stryker knee, hip implants have lowest revision rates | Research roundup
Here’s a roundup of recent clinical trial and scientific study news:
GOP moves against public opinion to de-fund healthcare reform
Allergan wins FDA approval for broader use of weight loss device
Allergan Inc.’s (NYSE:AGN) Lap-Band is now approved for use in less-obese patients.
The Food & Drug Administration approved the weight loss device for patients with a body mass index of at least 35, or a BMI greater than or equal to 30 along with at least one co-morbid condition, such as diabetes or hypertension.
The device, first approved by the FDA in 2001, was formerly indicated for use only in patients categorized as “severely obese,” with a BMI of 40 or 100 pounds or more over their estimated ideal weight.
Weekly Wireless Roundup: Obama details wireless initiatives
Obama details wireless initiatives: President Barack Obama last week detailed his plan to "win the future by catalyzing the buildout of high-speed wireless services that will enable businesses to grow faster, students to learn more, and public safety officials to access state-of-the-art, secure, nationwide, and interoperable mobile communications." The president’s so-called "Wireless Innovation and Infrastructure Initiative" includes plans for nearly doubling the wireless spectrum, providing 98 percent of Americans 4G access, and more security, which is a necessity for wireless medical devices and wireless commu
AtriCure climbs into the black for the first time
Cardiac surgical device maker AtriCure Inc. (NSDQ:ATRC) has reported its first-ever profitable quarter as sales of its AtriClip device continue to climb.
The company’s fourth-quarter earnings were scant, $11,500, but still far exceeded the consensus analysts’ estimate of a loss of 8 cents per share. Revenue also exceeded analysts’ estimates, rising 19 percent to $16.4 million. Analysts had expected $15.5 million.
Johnson & Johnson and Medtronic hit with recalls
Johnson & Johnson (NYSE:JNJ) and Medtronic Inc. (NYSE:MDT) are both grappling with new recalls.
Johnson & Johnson issued a voluntary recall for 70,000 syringes due to cracks.
New Brunswick, N.J.-based medical products giant said the products’ labeling covers the crack site and the flaw could affect the sterility of the syringe’s contents.
FDA slaps Bioptigen with warning over marketing claims
Medical imaging technology company Bioptigen received a warning from the Food & Drug Administration alleging that the company is marketing its eye imaging scanner without proper approvals.
The Research Triangle Park, N.C.-based company makes a medical device that allows for imaging of the inner areas of the eye. The company has marketed the product for research as well as medical applications.
Covidien wins 510(k) clearance for small jaw surgical tool | Regulatory roundup
Covidien plc (NYSE:COV) won 510(k) clearance for a new "small jaw" cutting and sealing surgical instrument.
The clearance adds another device to the Mansfield, Mass.-based medical products maker’s 12-year-old LigaSure line of surgical tools.
Boston Scientific adds two blocked artery treatment devices | Acquisitions roundup
Boston Scientific Corp. (NYSE:BSX) is adding two blocked artery treatment technologies two its portfolio of vascular treatment devices.
The Natick, Mass.-based medical device giant acquired a re-entry catheter from Israel-based S.I. Therapies Ltd. in November, and, with the pending acquisition of ReVascular Therapeutics Inc., the company is adding an intraluminal chronic total occlusions (CTO) crossing device. Both devices treat peripheral CTOs.