A group of American medical device manufacturers joined to launch a Japanese trade council, the American Medical Devices and Diagnostics Manufacturers’ Assn.
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FDA spikes wider use of Stryker’s OP-1 putty
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
Millstone Medical expands again
Millstone Medical Outsourcing is expanding again, this time at its Memphis operation.
The Fall River-based inspection and clean room services provider is adding 12,000 square feet to its facility in the Bluff City, taking its total to 43,600 square feet and increasing its inspection, storage and distribution capacities.
It’s the second expansion this year for Millstone, which opened a second location in its Fall River home base in February.
Amicas shutters Emageon’s Alabama HQ, to lay off 100 workers
Days after closing its difficult deal to acquire Emageon, Amicas Inc. shuttered Emageon’s Birmingham, Ala.-based headquarters and announced plans to lay off about 100 workers there, the Birmingham Terminal reported.
Calls to Amicas seeking comment were not immediately returned.
France to Boston Scientific and Medtronic: Pony up
How do you say, “Pony up” in French?
Whatever the literal translation, that’s what a French court said to medical device monoliths Boston Scientific Corp. and Medtronic Inc. after the pair lost a bid to squelch an anti-trust case there, the Bloomberg news service reported via Boston.com.
Millipore funds life sciences training lab at UMass-Lowell
Millipore Corp. donated $225,000 in equipment and services for a new process lab at UMass-Lowell aimed at developing the Bay State’s life sciences workforce.
The Billerica-based laboratory instruments maker‘s donation of clarification, chromatography, ultrafiltration/diafiltration and disposable mixing systems earned it the right to name the Millipore Corporation Process Development Laboratory, which will be used for downstream purification research and as a training facility.
Agion contributes to sexy new coatings
Agion Technologies Inc. will supply its antimicrobial technology to a sexy new medical device coating offered by Biocoat Inc.
Horsham, Pa.-based Biocoat, which makes “lubricious” hydrophilic coatings for catheters, stents and respiratory tubes, will incorporate Agion’s silver zeolite technology into its formula.
The coating is designed to inhibit the growth of microbes on implanted medical devices.
Thermo Fisher maintains Beverly residence
Scientific services giant Thermo Fisher Scientific, Inc. will keep its environmental instruments business unit housed at the Cummings Center for another three years.
The Waltham-based laboratory instruments maker has 170 employees in 107,000 square feet of leased space at the Beverly facility. Thermo Fisher is the Cummings Center’s largest client, and has occupied space in the center since 1996, according to officials at Cummings Properties, LLC.
Thermo Fisher Scientific employs 34,000 people worldwide.
Partners Healthcare bans sales reps from its halls
Medical device salespeople will no longer be able to drop in on physicians or make unsolicited calls to doctors in the Partners Healthcare system without a written invitation.
The Boston Globe first reported the stricter regulations, which are slated to go into effect October 1.
Partners Healthcare’s system includes Brigham and Women’s hospital, Massachusetts General Hospital, the Spaulding Rehabilitation Hospital Network and several other hospitals and clinics across the state.
NMT Medical’s StarFlex implant cleared for ventricular repair
NMT Medical Inc.’s StarFlex ventricular septum repair implant landed pre-market approval from the federal Food & Drug Administration.
The Boston-based company’s device is designed to be inserted into the hearts of patients with defects in the wall between the ventricular chambers.
The StarFlex implant closes the defect, preventing already-oxygenated blood from returning to the lungs before being pumped back into the body.
Eight Bay State medical device companies make the Forbes 2000
Eight medical device companies with operations in the Bay State made Forbes magazine’s “Global 2000” list.
The annual list ranks the world’s largest companies using a series of metrics including sales, profits, assets and market value.
