Latest Headlines

  1. Stryker Embarks On $130 Million R&D Expansion In Michigan

    Stryker is building a $130-million corporate campus in Portage, Mich., near Kalamazoo, where the medical device manufacturer is headquartered. The expansion creates 105 new area jobs for engineers and scientists over the next three years, officials said.

  2. FDA Makes Final Rule On Postmarketing Safety Reporting For Combination Products

    The U.S. Food and Drug Administration (FDA) has issued the final rule describing the postmarketing safety reporting requirements for combination products, which comprise any two or three constituent parts — namely, a medical device and/or a drug and/or a biologic.

  3. FDA Issues Ban On The Use Of Powdered Surgical Gloves

    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.

  4. J&J’s Animas Has Insulin Pump, First To Integrate Dexcom G5 CGM, Cleared By FDA And Health Canada

    Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada's authorization for the sale of the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for the treatment of patients age two and older living with diabetes.

  5. UK's NICE Joins FDA Program To Speed Payer Coverage, Access To Medical Devices

    The United Kingdom's National Institute for Health and Care Excellence (NICE) says it is working with the United States Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) in assisting sponsors of medical devices and diagnostics gather and demonstrate the clinical efficacy and cost-effectiveness of their products.

  6. Sanovas Subsidiary Launched To Fight Hospital-Acquired Infections

    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.

  7. Clarius’ Pocket-Sized, Wireless Ultrasound Scanner Cleared By FDA

    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.

  8. FDA Clears Wireless Integration Of J&J Glucometer With WellDoc Diabetes Management Platform

    Johnson & Johnson's Lifescan division says it has received clearance from the U.S. Food and Drug Administration (FDA) for wireless integration of its OneTouch Verio Flex glucometer with WellDoc's BlueStar diabetes management platform.

  9. Life Science Connect Appoints Chief Editor And Business Development Positions

    Life Science Connect, a business unit within the pioneering B2B media services company VertMarkets, announced two new appointments to the company’s Life Sciences team. Bob Marshall joins the Life Science Connect team as the Editor In Chief of Med Device Online.

  10. QT Vascular Gains IDE Approval For Pivotal Trial Of Its Drug-Coated Balloon

    QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease.