Myomo Inc.'s (Cambridge, MA) robotic prosthetic arm has been available since 2008, but now the company is offering the device directly to patients at a discount. The NeuroRobotic System isn't covered by insurance and had previously been sold to rehab centers and hospitals for $7000. The company has slashed the price to $4750 and will be offering the device to patients who pass a screening process. Patients will also need a doctor's prescription.
The prosthesis attaches to the arm and reads muscle signals to help patients as they move a limb. The Boston Globe reports that the company is currently conducting a 30-patient study to evaluate the most effective way to use the device.

August 9th, 2010
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CDRH says moving forward with a risk-based approach for providing regulatory oversight over laboratory-developed and commercially marketed tests will help assure physicians and consumers that test results are reliable. Speaking at a July 19 FDA public meeting in Hyattsville, MD, CDRH Office of In Vitro Diagnostic Device Evaluation and Safety personalized medicine director Elizabeth Mansfield said that such an approach would be likely phased in with higher-risk tests receiving agency scrutiny before moving to lower-risk tests.

Laboratory-developed tests (LDTs) have received considerable public attention lately. In May, FDA objected to San Diego–based Pathway Genomics' attempt to market an over-the-counter genetic test collection kit at Walgreens drug stores because it is outside the boundaries of the regulatory safe harbor for such tests, which are regulated by CMS. The agency has been bothered by broader claims made by test marketers. CDRH Office of In Vitro...

August 5th, 2010
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Got something to say to FDA? If you live in California, you just might be in luck.
From FDA:
The meeting will be held on October 7, 2010, beginning at 8:00 a.m., at the following location:

Hilton Irvine/Orange County Airport Hotel
18800 MacArthur Blvd
Irvine, CA 92612
Phone: (949) 833-9999

The meeting will not be videotaped or webcast.

Online registration is available. Registration will close on Wednesday, September 22, 2010.
If you wish to make an oral presentation during any of the sessions at the meeting, you must have indicated this at the time of registration. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled...

August 5th, 2010
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FDA released a 120-page report late yesterday detailing proposed changes to the maligned 510(k) process. The report was split in two, with the first part addressing preliminary recommendations to improve the process. The second part is a separate report from a CDRH task force that evaluated how the agency incorporates new scientific information into its regulatory decision making. 
The recommendations will be open for public comment before any changes are actually made. Some of the highlights:

  • FDA recommends developing guidance to clarify when other medical devices should not be used as a benchmark. The agency wants help from the public and industry to make these definitions clear.
  • The agency also wants to reiterate its authority to rescind prior device approval.
  • FDA recommends creating a subset of Class II medical devices that would require clinical or manufacturing data to demonstrate that they are substantially...
August 4th, 2010
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AAMI and FDA have announced a groundbreaking summit aimed at improving the safety of infusion pumps. The summit is scheduled take place Oct. 5-6 at FDA headquarters in Silver Spring, MD.

Now is the time to have your voice heard in this unprecedented effort to build a consensus and find constructive solutions to one of the top concerns in the healthcare community.

Infusion pumps are among the most widely used medical devices in today's healthcare system. Yet, between 2005 and 2009, FDA has received approximately 56,000 adverse events associated with their use.

This summit will be open to individuals and organizations that have a key interest in the improvement of these devices and in patient safety. Expected participants include:
 

  • Hospital and industry senior executives
  • Design engineers
  • Researchers and developers of drug delivery devices
  • Academicians
  • Pharmacists
  • Nurses
  • Surgical...
August 3rd, 2010
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A study published online in Mayo Clinic Proceedings says that in the United States withdrawing left ventricular assist devices (LVAD) at the end of a patient's life is ethical. According to the report “it is ethically and legally permissible” for physicians to comply with requests by patients (or their representatives) to “refuse or to request withdrawal of life-sustaining treatments” such as hemodialysis or artificial nutrition.
The researchers describe 14 cases where patients or their health-care surrogates requested the assist device be turned off. They say that withdrawing LVAD support isn’t the same as assisted suicide or euthanasia because there’s no “new pathology” introduced to cause death. All 14 patients died within a day of turning off the device. But their death was due to the underlying heart failure, researchers write. So assuming patients or their representative know the consequences of deactivating the...

August 3rd, 2010
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Zoll Medical's automated external defibrillators (AEDs) will soon be imported and distributed in Japan. The Japanese Pharmaceutical and Medical Devices Agency granted approval to Zoll's AED Plus and AED Pro. Both technologies will be the only AEDs available in Japan that have real-time CPR feedback capability. The company is currently finalizing a deal with a major distributor in Japan. According to Zoll, the Japan AED market is second in unit sales to the United States. Since approval of the use of AEDs by nonprofessionals (which began in 2004), the market has grown to nearly 80,000 units annually, with a value of $200 million.

August 2nd, 2010
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FDA's Orthopedic and Rehabilitation Devices Panel voted 6-5 in favor of Medtronic's new Amplify spinal implant. The device is designed to stimulate bone growth in patients who have had spinal surgery. Last week FDA voiced concerns about the number of cancer cases seen among patients treated with the Amplify, which uses a protein called recombinant bone morphogenetic protein-2, or rhBMP-2, to promote bone growth. Although FDA is not required to follow the recommendation of the panel, it usually does.

July 29th, 2010
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St. Jude Medical has filed a patent infringement lawsuit against Volcano Corp. that accuses the company of infringing on key patents used for St. Jude's PressureWire interventional technology for its PrimeWire products. Both companies use an index called Fractional Flow Reserve (FFR) to evaluate blood flow blockages in the heart. St. Jude acquired the technology from Radi Medical Systems when it acquired the firm in 2008.
"St. Jude Medical has made significant investments in the interventional cardiology space, including the coronary assessment and more recently the coronary imaging markets,” says Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “From clinical research to important product advancements, Radi Medical Systems and now St. Jude Medical have contributed considerably to the success of this marketplace. As a company that values the innovations we bring to the marketplace, we intend to protect our...

July 28th, 2010
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According to a new study led by Cunlin Wang, MD, an epidemiologist in the Office of Surveillance and Biometrics at FDA, more than 70,000 children are sent to emergency rooms a year as a result of using medical devices, such as contact lenses. The analysis is online in the journal Pediatrics.
Wang’s study shows that 70% of the injuries are caused by ophthalmic devices (including contact lenses and eye glasses), general hospital devices (hospital beds, and catheters for example), and OB-GYN devices.
The statistics were gathered between early 2004 and late 2005 and were based on information gathered from the national database for pediatric injuries. Nearly 145,000 injuries were reported in emergency rooms during this period. About 23% of those injuries were caused by contact lenses, while hypodermic needles accounted for 8%.

July 27th, 2010
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