Life Sciences Newsbriefs: Week of February 7, 2011

Medical Devices

Mobile MIM app for iPhone, iPad gets FDA OK

The FDA has cleared MIM Software's Mobile MIM application for use with Apple's iPhone and iPad to view and interpret medical images. The agency, however, clarified that the application should not replace complete workstations and should be used only when workstations are not available.

Senate bill seeks to promote innovation

Sens. Amy Klobuchar, D-Minn., and Scott Brown, R-Mass., have proposed a bill that would promote innovation by setting up a loan guarantee program for small and medium-sized technology firms, among other provisions. AdvaMed has expressed support for the Innovate America Act, saying the bill includes "thoughtful policies that will help maintain American competitiveness, including provisions to identify and remove regulatory barriers that undermine innovation and the growth of exporting industries like the medical technology industry."

Senator files bill that would revoke device tax in health reform law

Sen. Scott Brown, R-Mass., has introduced a bill that would repeal a provision in the health reform law that calls for device firms to pay a 2.3% tax starting in 2013. "For some of these companies, that's their entire net profit. That's jobs, it's R&D, it's a whole list of other things. It's not a necessary tax," Brown said. Boston Scientific CEO Ray Elliott lauded the senator's effort, saying Brown's bill "would help the U.S. maintain global leadership in the development, manufacturing and export of medical technology."

FDA clears customized knee implant from ConforMIS|

The FDA has awarded 510(k) clearance to ConforMIS for its iTotal CR, a knee implant system that can be tailored for each patient using 3-D CT scans. Traditionally, surgeons have to pick from one of six or seven sizes of implants for their patients. "The challenge that you have with this technique is that the implant can never fit quite right," ConforMIS CEO Phillipp Lang said.

St. Jude Medical CEO says devices for atrial fibrillation to boost growth

St. Jude Medical CEO Daniel Starks said he believes the company will continue to experience sales growth, driven by new pacemakers and other cardiac-rhythm management devices that are designed to treat atrial fibrillation. The company said it has sufficient cash to buy back shares and acquire companies.

Device makers look for specialists with contacts

Medical device firms in the U.S. are seeking skilled individuals who already have contacts with health professionals. Moreover, they are ramping up employment abroad, especially in Europe, as the regulatory process in the U.S. remains in flux, according to this report. Positions in regulatory affairs and clinical operations also are in demand, said Joe Mullings, president and CEO of medical search company Mullings Group.

Hansen Medical sells technology rights to Philips Healthcare

Hansen Medical said it will get $29 million in upfront payments after selling to Philips Healthcare rights to develop and commercialize its Fiber Optic Shape Sensing and Localization technology for nonrobotic applications. Hansen could receive as much as $78 million in future payments for the FOSSL technology, which enables doctors to determine the shape and place of devices, such as catheters, during less-invasive procedures.

Cellnovo lands $48M in funding for diabetes management system

London-based Cellnovo has raised $48 million in a Series B round of financing spearheaded by Edmond de Rothschild Investment Partners. The money will be used to market a mobile diabetes management system that can wirelessly transmit data and deliver insulin to patients, Cellnovo officials said.

Mazor signs European distribution deals for SpineAssist device

Israel-based Mazor Robotics has signed agreements that call for AB Medica and InSpine to sell its SpineAssist surgical robotics system in Italy and the Netherlands, respectively. The company also plans to look for a distributor in South Korea during the second quarter.

MRI may better detect ischemic stroke in children, researchers say

Researchers learned that computer tomography was able to detect 100% of hemorrhagic stroke cases but only 50% of ischemic stroke cases among children. They wrote in the Annals of Emergency Medicine that magnetic resonance imaging may be a better tool to diagnose pediatric ischemic cases.

Researchers develop blood test using sensor-equipped microchip

Canadian researchers have developed a blood test that uses a microchip with sensors for collecting and electronically sending results from a small sample of blood. The researchers said the test is cost-effective, and they plan to work with local laboratories and health care workers regarding the use of the test. The research was published in the journal Lab on a Chip.

Medline buys CareFusion division for $130 million

Medline Industries has agreed to pay $130 million to acquire CareFusion's International Surgical Products unit. The sale of the Switzerland-based unit will allow CareFusion to focus on expanding its lines of infusion pumps, drug-delivery systems and other products included in its core portfolio.

Device firms expect to see little impact on ICDs sales

An article published in the Journal of the American Medical Association that raises concerns about the possible overuse of implantable cardioverter defibrillators as well as the Heart Rhythm Society's announcement that it will take part in the Justice Department's investigation into ICDs will not have a significant and long-term effect on the sales of the devices, according to some device firm executives. St. Jude Medical CEO Daniel Starks criticized the report, describing it as "old news" for clinicians who are implanting such devices.

Foundation plans to set up incubator program in Germantown, Tenn.

Officials at Memphis Bioworks Foundation are considering setting up an incubator program in Germantown, Tenn., to support medical device startups. Although the Germantown Economic Development Commission has expressed support for the proposal, city officials have yet to decide how much to would spend on the program.

Glaukos gets $29.5M in fifth venture capital financing round

Glaukos announced that it has secured $29.5 million in its latest financing round led by Meritech Capital Partners. Glaukos is developing an implantable device designed to treat glaucoma.

Frazier Healthcare acquires Laboratory Supply

Frazier Healthcare, which provides venture capital to device and biopharmaceutical firms, has agreed to buy diagnostic and laboratory instruments supplier Laboratory Supply for an undisclosed sum. Steve Nielsen, former president and CEO of Activus Healthcare Solutions, has been named CEO and chairman of LABSCO.

Toshiba allots about $25M for imaging center in Scotland

Toshiba Medical Visualisation Systems has allotted some $25 million for the development of a health imaging and research center in Edinburgh, Scotland. As part of the project, Toshiba will develop advanced medical technologies, including nuclear medicine systems.

Ireland-based seed fund to focus on device startups

Kernel Capital, a venture capital firm, has...