Category: Device News
Device specific news; Announcements, reports, reviews and device specific news
A special panel convened by the Food & Drug Administration narrowly cleared Medtronic's Activa DBS deep-brain stimulation device for treating epilepsy, despite concerns over its efficacy and safety.
By Thomas Lee
A Food & Drug Administration panel narrowly approved a deep brain stimulation device developed by Medtronic Inc. (NYSE:MDT) to treat epilepsy.
The panel voted 7-5 to green-light the Activa DBS, which uses electricity to stimulate the anterior nucleus region of the brain. The panel’s findings are not binding on the FDA, but the agency almost always follows the recommendations of such bodies.
Hopkinton, Mass.-based lab equipment and services provider Caliper Life Sciences reaches a settlement with Shimadzu Scientific Instruments Inc. over its electrophoresis system.
Caliper Life Sciences, Inc. (Nasdaq: CALP) says that Shimazdu Scientific Instruments, Inc. has agreed to remove one of its DNA and RNA sequencers from the U.S. market after the company's settled a 14-month patent dispute.
The Hopkinton, Mass.-based lab equipment and services provider had alleged that Shimazu's MCE-202 MultiNA microchip electrophoresis system infringed on 11 different U.S. patents held by Caliper. The MultiNA is a microchip electrophoresis system the company says can quickly and easily perform DNA and RNA nucleic acid size confirmation and quantitation in life science research.
Boston Scientific Corp.'s stock dips on news that it's holding all shipment of its implantable cardiac defibrillators and cardiac resynchronization therapy devices, after discovering it missed filings with the Food & Drug Administration.
Boston Scientific Corp. (NYSE:BSX) is holding all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulling all inventory from the field after discovering that it missed a pair of filings with the Food & Drug Administration.
The medical device-making giant said it failed to notify the FDA of two changes to its manufacturing process for its Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality ICDs and CRT-Ds. The changes were "successfully validated" and there is no risk to patient safety, according to a press release. Boston Scientific's pacemakers and other products are not affected by the move.
Medtronic Inc. launches a 1,000-patient study of its CoreValve aortic stenosis therapy, designed as a minimally invasive method of replacing faulty heart valves.
By Brandon Glenn
Medtronic Inc. (NYSE:MDT) launched what’s expected to be a 1,000-patient study of a catheter-based system it hopes will become a less-invasive — and highly lucrative — alternative to open-heart surgery for valve replacement.
Medtronic’s CoreValve system allows a replacement heart valve to be placed in a patient’s body via a catheter inserted in the femoral artery, near the groin. A catheter is a thin, flexible tube that can be inserted into a body cavity to open a passageway or to allow fluids to pass through.
The Food & Drug Administration issues a warning to healthcare providers about counterfeit surgical mesh products that ape C.R. Bard's Davol brand.
The Food & Drug Administration is warning healthcare providers to be on the lookout for fake surgical mesh products that ape C.R. Bard's (NYSE:BCR) Davol Inc. brand, saying hospitals and surgical centers — not to mention patients with surgical mesh implants — should be especially vigilant.
The federal watchdog agency said four sizes of the counterfeit flat sheet polypropylene surgical mesh have been pegged by the FDA and Bard so far:
Holliston, Mass.-based scientific instrument maker Harvard Bioscience launches a bioreactor as it looks to enter the regenerative medicine market.
When surgeons in Spain successfully replaced a young woman's trachea in 2008, using a tissue-engineered windpipe researchers had grown out of her own stem cells, the world took notice.
David Green, the president of Harvard Bioscience Inc. (NSDQ:HBIO), a Holliston, Mass.-based lab instruments maker, also noticed. Green picked up the phone to call Italy shortly after the news hit the wires; this week the company launched a commercial version of the bioreactor researchers used to grow the bronchus, the ORGANIZER Series Model 100 "In Breath" bioreactor.
The Food & Drug Administration and Health Canada both cleared a Polish reactor to supply Covidien with scarce molybdenum 99, which the Mansfield, Mass.-based company will use to make the radiological isotope technetium 99.
Covidien (NYSE:COV) won clearance from the Food & Drug Administration and its counterpart north of the border, Health Canada, to begin using a Polish nuclear reactor to supply a scarce medical isotope.
The Mansfield, Mass.-based medical products conglomerate can start using molybdenum 99 from the Polish Institute of Atomic Energy's Maria reactor to make technetium 99, which is used in imaging procedures.
