Doctors are ditching their trusty stethoscopes in favor of smartphones to monitor their patients' heartbeats, according to a recent story. A researcher from University College London has created an iPhone app—which has already been downloaded more than 3 million times—that turns the device into a stethoscope. A free version of the app was introduced last week.
 
"Smartphones are incredibly powerful devices packed full of sensors, cameras, high-quality microphones with amazing displays," said app creator Peter Bentley. "They are capable of saving lives, saving money and improving healthcare in a dramatic fashion – and we carry these massively powerful computers in our pockets."

September 1st, 2010
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Three former executives of Spectranetics are accused of illegally importing unapproved medical devices in a 12-count criminal indictment announced this week. Also named in the indictment, which was announced by Colorado U.S. attorney John Walsh's office, was a representative of a Florida company contracted by Spectranetics. The four are listed below:

  • George John Schulte, 62, former CEO
  • Obinna Adhigije, also known as Larry Adighije, 50, former VP of business development
  • Trung Pham, 37, former business development manager
  • Hernan Ricaurte, 41, former contract rep

The charges include conspiracy, making false statements, receipt of illegal imports, sales of adulterated and misbranded medical devices, and other offenses. (Note that not every defendant is being charged with every crime.)

 

August 31st, 2010
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Government requirements for hospitals to get cash rewards for the meaningful use of electronic health records may be too stringent for many facilities, according to a survey conducted by the American Hospital Association.
According to survey report "A small fraction of U.S. hospitals reported using electronic medical records software last year and even fewer would have met new requirements for 'meaningful use' of the systems in 2009."
The AHA polled 3,100 members. Only 12% used electronic records and only 2% would have met the requirements drafted by the federal government to win the payments.
To be eligible for financial incentives, hospitals must demonstrate that they meet 14 core objectives and five of the ten menu objectives. AHA found modest increases in adoption of electronic health records between 2008 and 2009. Larger, nonprofit, urban hospitals made more headway...

August 31st, 2010
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The concept may be a bit strange, which is why it's probably still experimental. Researchers from UFL's College of Medicine conducted a study that showed that surgical robots could be used to enable anesthesiologists to perform robot-assisted procedures from remote locations. Using the daVinci robot, experiments using an ultrasound phantom  simulated what an anesthesiologist would see. Note: human patients were not used as subjects in the study. Once the anesthesiologist placed the ultrasound probe, a catheter placement procedure was performed. Although the study showed that teleanesthesia is possible with existing equipment, Steven Shafer of Columbia University says that there aren't enough skilled regional anesthesiologists to meet the demand. The technology is also still too young, but Shafer says that if future studies demonstrate that the technology is practical, then one highly trained anesthesiologist could...

August 30th, 2010
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By now we've all heard horror stories about surgical sponges and other tools being left inside patients. The latest FDA-approved creation to keep these items from setting up permanent residence next to internal organs is the ORLocate. It uses radio-frequency technology to track sponges and surgical tools. In fact, ORLocate manufacturer Haldor Advanced Technologies Ltd. says that the system is the only RFID-based method that goes beyond counting sponges to include surgical instruments.

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August 26th, 2010
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Companies have had varying responses to FDA's recent investigation of genetic tests. MD+DI columnnist Jim Dickinson adds:
 
San Diego-based Sequenom says it is disputing a recent FDA untitled letter seeking regulatory approval or clearance of the company’s genetic test. FDA’s letter is part of a recent crackdown on so-called laboratory-developed tests (LDTs) under which the agency asserts approval authority over devices that are more commercial in nature.

According to FDA’s letter in July, it had come to the agency's attention that Sequenom was marketing without approval or clearance its SEQureDx, “a prenatal genetic diagnostic technology, intended to enable the detection and analysis of circulating...

August 25th, 2010
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Several FDA advisory committees are meeting before the year is out to discuss and make recommendations on a variety of products and issues. The meetings concerning medical devices are listed below:

RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Sept. 24, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Shanika Craig, 301-796-6639
The committee will discuss, make recommendations and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic Inc (HOLX.O). The Selenia C Digital Breast Tomosynthesis System is intended for use in the same clinical applications as traditional mammographic systems....

August 25th, 2010
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Senator Amy Klobuchar (D-MN) delivered the keynote address at a LifeScience Alley conference on Monday, Aug. 23 featuring leaders from Minnesota’s medical device and health care industries.
“Minnesota is a national leader in the healthcare community, setting the standard for high-quality, affordable patient care,”Klobuchar said. “The medical device industry will help us continue to build a healthcare system that is streamlined, innovative, and able to harness the power of technology.”
In her remarks, Klobuchar highlighted the importance of medical technology and innovation in the U.S. economy and outlined how healthcare reform will benefit Minnesotans. She also discussed Minnesota’s medical device industry and the new FDA report that addresses 510(k) approval process.
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August 24th, 2010
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If you missed the live Q&A with medical device experts held in June at MD&M East, now is your chance to hear what issues the panel discussed, right in the comfort of your own office. The "Innovations in Global Healthcare" webcast featured panelists from AdvaMed, Abbott Medical Optics, Rocket Medical, and Qiagen who answered questions from the editors of MD+DI, MPMN, EMDT, and IVD Technology. Global issues discussed include innovation, healthcare reform, comparative effectiveness, changes at FDA, and convergent and emerging technologies.

August 23rd, 2010
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Battelle collaborates with OhioHealth's CME+I on conducting patient simulation testing.

With more scrutiny from FDA and more hospital restrictions, how can device manufacturers--especially early-stage companies--get their product to market successfully? One method that is significantly helping product designers is patient simulation. R&D firm Battelle (Columbus, OH) works with OhioHealth's Center for Medical Education + Innovation (CME+I) on providing the user feedback that designers need to make their products safer and more user friendly. Conducting...

August 16th, 2010
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