The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
Following recent meeting of India’s Drug Technical Advisory Board and Drug Consultative Committee, proposals to expand the list of Notified medical devices requiring registration have emerged.
By Stewart Eisenhart, Emergo Group
Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.
Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.
Two-and-a-half years after studies appeared in the New England Journal of Medicine questioning the efficacy of routine prostate cancer screening for middle-aged men, the U.S. Preventive Services Task Force finally issued its recommendation based on a review of the science. Its recommendation: don’t bother taking the test.
Carticept Medical™ Receives FDA Clearance for Automated Injection System with Integrated Ultrasound Guidance
Navigator™ Delivery System automates drug preparation, delivery, record-keeping and allows physicians to pinpoint needle placement
ALPHARETTA, Ga.–(BUSINESS WIRE)–Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that it has received 510(k) clearance from the Food and Drug Administration to market its Navigator™ Delivery System (Navigator DS) in the United States. The Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.
LEXINGTON, Mass. & SYDNEY–(BUSINESS WIRE)–GI Dynamics, Inc. (ASX: GID) announced new data results that reveal changes in certain hormones in patients treated with the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), which results in rapid improvement in glycemic control and weight loss. These data were presented during an oral session at the 47th Annual Meeting of the European Association for the Study of Diabetes and Obesity (EASD).
“The rapid increase in certain hormones and immediate changes in glycemic control seen with the EndoBarrier in this study further support the theory that it works by affecting hormone levels”
CI Medical, Inc. has developed break-through technology which enables the use of its trademarked Radiopaque® ink on silicone medical devices. Historically, bonding to silicone has been challenging due to low surface energy of this elastomer. Through a proprietary process combining Radiopaque® ink created by CI Medical with a binder exclusively formulated for its use by NuSil Technology, CI has developed the technology which results in permanent Radiopaque® marking on silicone medical devices.
Coghlin Companies added 60,000 square feet to its manufacturing footprint.
The contract manufacturing and engineering firm’s new cleanroom space in Westborough, Mass., will support its manufacturing and engineering divisions, allowing for several new industrial automation integration programs, according to the company. The Worcester, Mass.-based company said the new space would enable it to hire up to 50 new employees.
When Mike Selzer first reviewed the work of University of Minnesota scientist Dr. Erik Cressman — a way to kill cancer cells in the liver using chemical-generated heat — the veteran medical device executive was impressed.
Cool technology, he thought.
“You can’t build a company around [liver cancer],” said Selzer, an adviser at the time to the school’s Venture Center, the unit of the Office for Technology Commercialization responsible for spinning out companies from university technology.
Researchers have discovered a pair of genetic mechanisms that could hold the keys to gene therapies for alcoholism and depression.
A post-market study has been conducted by the Brånemark Clinic in Gothenburg on Artelon Cosmetic for soft tissue augmentation in the upper jaw. The study confirms that patients with tissue defects can be treated successfully with Artelon Cosmetic.
Dr. Bertil Friberg, who conducted the study at the Brånemark Clinic, states: “Artelon is an interesting material for dental applications. In this particular study we demonstrate that Artelon Cosmetic integrates well with body tissue and volume augmentation is maintained over time.”
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