suzanne-hodsden-articles
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FDA Issues Ban On The Use Of Powdered Surgical Gloves
12/21/2016
FDA has issued a ban on the sale, manufacture, and use of powdered surgical and examination gloves — as well as associated absorbable powders — that will begin on January 19, 2017. The agency first proposed the ban in March, citing evidence of wound inflammation, allergies, and post-surgical adhesions and complications.
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Sanovas Subsidiary Launched To Fight Hospital-Acquired Infections
12/19/2016
Sanovas has announced the launch of SteriView, a wholly-owned subsidiary specializing in technology that fights hospital-acquired infections (HAIs). The SteriView instrument inspection and infection control system is touted as a “front-line” solution for device reprocessing that allows technicians to directly view hard-to-reach places on reprocessed medical devices.
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Clarius' Pocket-Sized, Wireless Ultrasound Scanner Cleared By FDA
12/16/2016
Clarius Mobile Health — a Canada-based digital healthcare company — announced that FDA has cleared its handheld, wireless ultrasound scanner, suitable for quick, point-of-care (POC) scans and short procedure guidance.
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Siemens Invests $300M In Massachusetts Manufacturing Facility, Broadens Footprint In U.S.
12/15/2016
Siemens Healthineers will broaden its footprint in the United States by investing $300 million into its manufacturing facility based in Walpole, Mass. The facility, which manufactures immunoassay instruments and houses a portion of Siemens Healthineers’ R&D efforts in diagnostics, will begin renovations in the summer of 2017.
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FDA to Notify Public of “Emerging Signals” of Medical Device Safety
12/14/2016
FDA plans to proceed with a new adverse event reporting protocol, which will alert the public to medical device safety concerns, or “emerging signals,” while the agency still is investigating claims.
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Implantable Drug-Delivery Device Could Treat Cancer, HIV, Or Chronic Disease
12/13/2016
A multidisciplinary team of scientists from Texas has developed an implantable drug delivery device that uses nanochannels to regulate dosage of drugs over time. Researchers say the implant is “drug agnostic” and could potentially be paired with a variety of pharmaceutical treatments for a host of diseases or ailments, such as cancer therapies, HIV drug cocktails, immunotherapy, or cortisone injections for joint pain.
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Edwards CEO Lays Out Heart Valve Repair, Replacement Product Pipeline
12/12/2016
Edwards Lifesciences hosted an investors’ day to lay out its long-term growth strategy and introduce products in their cardiovascular pipeline, particularly with valve repair and replacement. The company plans to introduce new therapies and expand indications for Edwards products currently on the market, investing “aggressively” in the research and development of “transformational” therapies, according to CEO Michael Mussallem.
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Medtronic, Fitbit To Build An App That Tracks Both Activity And Glucose
12/9/2016
Fitbit has pushed further into medtech by inking a partnership with Medtronic. The companies plan to leverage Fitbit’s activity tracking expertise with Medtronic’s continuous glucose monitoring (CGM) systems to develop a an app that will help both patients with type 2 diabetes and their doctors understand the connection between physical activity and glucose levels.
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“Neural Tourniquet” Uses Electrical Signals To Staunch Bleeding
12/8/2016
A recent advance in bioelectronic medicine may be able to stop internal or external bleeding by stimulating certain nerves in the brain using a “neural tourniquet.” Researchers from the Feinstein Institute for Medical Research (FIMR) believe the treatment could be used in battlefield medicine, emergency care, surgery, or post-partum treatments to treat or prevent hemorrhaging.
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Senate Ends Debate Over “Cures;” Bill Expected To Pass This Week
12/7/2016
A cloture vote by the U.S. Senate on Tuesday has ended debate in the Senate over the 21st Century Cures Act and paved the way for a vote on passage of the bill, which could happen as soon as today. Under cloture, a procedure intended to break filibusters, the Senate may limit consideration of a pending matter to 30 additional hours of debate.