Technology giant Siemens (NYSE:SI) won FDA clearance to begin distributing the Artis Q and Artis Q.zen angiography systems in the U.S. The technology includes a new X-ray tube with lower radiation levels and updated software for more precise imaging, according to Siemens.
Abiomed lands reimbursement expansion for Impella heart pump
Abiomed (NSDQ:ABMD) won expanded reimbursement for its flagship Impella heart pump from 4 private and Medicare Advantage insurers, including 1 of the largest names in the industry.
Humana, UnitedHealthcare Medicare Risk, Independence Blue Cross and Capital Blue Cross. The expanded coverage at the private or Medicare Advantage plans includes new Impella policies.
Avedro lands $43M in Series D financing round
Medical device company Avedro finished up a $43 million Series D financing round this week with the help of a pair of new investors, venture capital shops Third Point and Abingworth.
To tie the knot, Avedro is bringing on 2 new board members from its latest backers, Abingworth’s David Maye and Jason Hong of Third Point.
Avedro’s products are used primarily in support of Lasik laser eye surgery. The company is currently wrapping up Phase III clinical trials. Currently, none of the company’s products are for sale in the U.S.
GI Dynamics names Brazilian EndoBarrier distributor
GI Dynamics (ASX:GID) sealed a deal with CMS Medical to distribute its EndoBarrier weight loss and diabetes device in Brazil, hoping to hit the market there by early 2014.
InVivo updates bid for FDA OK of spinal trauma treatment
InVivo Therapeutics (OTC:NVIV) hopes to begin testing in humans in an open-label safety and efficacy study now that it’s updated its submission for an investigational device exemption submission for its spinal cord injury treatment.
InVivo filed the original investigational device exemption application in July 2011, but has yet to be approved.
Diabetes: LifeScan nabs first FDA-cleared mobile health blood glucose monitoring system
LifeScan, has received regulatory clearance from the FDA for its OneTouch VerioSync blood glucose monitoring system, the first monitoring system to integrate with the Apple app store.
The app, called the OneTouch Reveal, is available on iPhone, iPad or iPod touch.
The system automatically sends blood glucose levels to mobile devices, displaying information in a 14-day summary with simple visual breakdowns. Patients can also share information via text or email or with their doctors or friends.
FDA updates guidance on pulse oximeter applications
The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.
Medtronic lands EU approval for Attain Performa CRT-D leads
Premier strikes CRM deals with Medtronic, Boston Scientific, others
Group purchasing organization Premier Healthcare Alliance struck a deal with 4 major players in the cardiac device market for several cardiac rhythm management device portfolios.
Massachusetts Life Sciences Center awards $25 million in tax incentives
The Massachusetts Life Science Center has doled out more than $25 million to 25 life science companies who pledged to create new jobs in its latest round of tax incentives,
Earnings: Natus Medical swings to black in Q4
Natus Medical (NSDQ:BABY) rode a strong 4th quarter to swing into the black during 2012.
The San Carlos, Calif.-based diagnostic and device maker posted a $4.76 million, or 29¢ per diluted share profit, on sales of $90.5 million during the 3-month period on December 31st, compared with a $17.3 million, or 14¢ per diluted share loss, on sales of $64.1 million during the same period last year.