The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Medtronic Inc.’s (NYSE:MDT) got the go-ahead to pursue trials of its Symplicity catheter system for treating hypertension via renal denervation.
The system includes a catheter inserted into the renal artery near each kidney via the femoral artery in the upper thigh. A generator on the tip of the catheter delivers lower-power radio-frequency energy to "deactivate" the sympathetic nerves, lowering blood pressure.
Hundreds of representatives from New England’s medical device industry gathered last night at the MassDevice Big 100 Regional Roundtable at the Westin Hotel in Waltham, Mass., to share their experiences and ideas for the industry’s future.
MASSDEVICE ON CALL — The revamped breast implant is safer than the last generation, which was pulled off the market in 1992 over fears of leakage, but the silicon prosthetics still come with risks, the U.S. Food & Drug Administration warned.
The implants are safe in general, the agency said, but complications are common and the implants aren’t going to last forever.
The U.S. Food & Drug Administrations filed a warnings against ZOLL Medical Corporation (NSDQ:ZOLL) for allegedly failing to validate battery life cycles for its external defibrillators.
Zoll has logged 15 complaints between September 2009 and January 2011 alleging that the batteries in the Chelmsford, Mass.-based company’s automated external defibrillators died prior to their 5-year expectations, the agency said in its letter.
MASSDEVICE ON CALL — Johnson & Johnson (NYSE:JNJ) could shell out up to $1 billion for lawsuits concerning its subsidiary DePuy Orthopaedics and the metal-on-metal hip implants that were found to shed minute metal particles into a patient’s bloodstream over time.
InVivo Therapeutics (OTC:NVIV) wants the FDA’s blessing for a human trial of its biopolymer scaffold to treat traumatic spinal cord injuries.
Sen. John Kerry (D-Mass.) is making some moves to protect one of his major business constituencies in the Bay State.
The senior senator from Massachusetts will host a pair of meetings in Boston July 11 between FDA commissioner Dr. Margaret Hamburg, Center for Devices & Radiological Health chief Dr. Jeffrey Shuren and representatives from the Commonwealth’s medical device and biotechnology industries in an effort to open up a dialogue between the oversight bureau and two of the state’s most critical industries.
The FDA could be softening its stance on sweeping changes to the way most medical devices go to market, according to comments made by agency officials at a recent negotiation meeting over user fees.
Representatives for the watchdog agency told negotiators for the medical device industry that it was “not bound to adopt IOM recommendations” on the 510(k) program. The IOM was tasked by the FDA to do a soup-to-nuts review of the program in late 2009 and is expected to release a long awaited report at the end of the month. Many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.
The U.S. Food & Drug Administration may relax premarket notification requirements for certain in vitro diagnostic and radiology devices, according to a draft guidance issued by the agency this week.
The draft guidance lists 30 different device types that the FDA intends to exclude from 510(k) requirements, including common urine and blood tests, alcohol breath tests, blood clotting protein tests, and radiology device accessories, such as film cassettes, film processors, and digitizers.
MASSDEVICE ON CALL —Doctors at Sweden’s Karolinska University hospital implanted the world’s first fully synthetic organ into a patient last month, effectively ridding the man of the cancer that threatened his life.
The 36-year-old male patient received a trachea made of his own stem cells, doing away with the risk of rejection or the need for a lifetime of immunosuppressive drugs.
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD June 2011
DEVICE: INVADER FACTOR V
HOLOGIC, INC. 510(k) NO: K100980(TRADITIONAL)
ATTN: RANDALL J COVILL PHONE NO : 508 263 8853
250 CAMPUS DRIVE SE DECISION MADE: 01-JUN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONNEX VITAL SIGNS MONITOR 6000 SERIES
WELCH ALLYN, INC. 510(k) NO: K110516(SPECIAL)
ATTN: FRED SCHWEITZER PHONE NO : 315 554 4001
