MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Medtech regulatory news for the week of Mar. 17, 2014

Medtech regulatory news for the week of Mar. 17, 2014

By

U.S. FDA considering new requirements for off-label use data

March 12, 2014 by MassDevice

YYYYALTTAG

By Stewart Eisenhart, Emergo Group

US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.

Revising guidelines originally issued in 2009, the FDA has now developed recommended best practices for manufacturers providing information to medical or scientific publications that discuss unapproved uses for devices already registered for sale in the US. Read more

Another warning letter for Hospira

March 12, 2014 by Arezu Sarvestani

Another warning letter for Hospira

Infusion technologies maker Hospira remains in the FDA’s cross-hairs after agency inspectors asked for more information about a North Carolina manufacturing facility that has been in hot water for years.

In the new warning, FDA officials cited at least 1 device malfunction in the field associated with injection systems that failed leak testing but were nonetheless allowed on shelves. One of the devices in the product lot was labeled “non-conforming” during October 2012 testing, but that failure was deemed unrepresentative of the batch and the devices were sent to market anyway, inspectors said. Read more

SafeOp Surgical lands FDA nod for neuromonitoring device

March 13, 2014 by Brad Perriello

SafeOp Surgical lands FDA nod for neuromonitoring device

SafeOp Surgical said it won 510(k) clearance from the FDA for its EPAD neuromonitoring device.

The Stamford, Conn.-based company develops technology used to detect peripheral nerve damage caused by nerve compression or stretching. Read more

Boston Scientific's Ingevity MRI-safe cardiac pacing leads win EU nod

March 14, 2014 by Brad Perriello

Boston Scientific's Ingevity MRI-safe cardiac pacing leads win EU nod

Boston Scientific said it won CE Mark approval in the European Union for its Ingevity pacemaker leads, designed to be safe during MRI scans.

The Natick, Mass.-based medical device company said it’s already launched the Ingevity leads in countries that recognize the CE Mark. Read more

In case you missed it

RSS From Medical Design & Outsourcing

  • Forecasting the future of urology with Boston Scientific’s Meghan Scanlon
    Meghan Scanlon, Boston Scientific’s president of urology and pelvic health, discusses the field and the challenges and opportunities ahead. The urology specialty faces a critical moment, with 10 urologists ready to retire for every new urologist entering the field, said Meghan Scanlon, SVP and president of urology and pelvic health at Boston Scientific (NYSE:BSX) That… […]
  • Women researchers receive a fraction of funding from the world’s biggest medtech companies
    The gender divide in medtech extends beyond leadership and into funding for investigational studies by U.S. physicians. Only 6.7% of physicians who received research payments from the world’s largest medical device companies in 2020 were women, according to an analysis of Medical Design & Outsourcing’s Big 100 list of medtech companies and CMS Open Payments… […]
  • Pentax Medical expands Vizient contract to include pediatric endoscopes
    Pentax Medical today announced it has expanded its contract with Vizient to include pediatric endoscopes. The contract will give Pentax Medical the ability to offer endoscopes to Vizient member hospitals through the Vizient Pediatric Program. The agreement also includes other value-added offerings, education opportunities and best practices. Get the full story on our sister site,… […]
  • Hologic plans to buy Bolder Surgical for $160M
    Hologic Inc. (NSDQ:HOLX) has a $160 million deal to acquire Bolder Surgical, a developer and manufacturer of advanced energy vessel sealing surgical devices. It’s the latest deal by Hologic, which has been spending COVID-19 test revenue generated by its diagnostics business on acquisitions across the company’s business lines, as CFO Karleen Oberton and CEO Steve MacMillan… […]
  • Koya Medical reports positive early results in Dayspring lymphedema trial
    Koya Medical this week announced positive results from a small, ongoing trial comparing its Dayspring compression treatment for lymphedema to a traditional pneumatic compression pump. The Oakland, California-based company secured FDA 510(k) clearance for the device last month, saying it was the first such approval for an active compression treatment enabling movement and mobility with… […]
  • OneProjects raises $17M to advance 4D cardiac imaging
    Irish-German cardiac imaging startup OneProjects today announced $8 million in Series A2 funding and two grants totaling $9 million. The company will use the new funds to complete product development, conduct clinical trials, gain FDA clearance and prepare for U.S. commercialization of the first product developed from its proprietary 4D cardiac imaging platform, Verafeye. The… […]
  • Women in Medtech 2021: Lindsay Fleming, Avient Corp. Commercial Manager, Healthcare — Color & Additives
    Lindsay Fleming is the Healthcare Commercial Manager for the Color & Additives division at Avient Corporation, a premier provider of specialty polymer formulations, color and additive systems, packaging solutions, and polymer distribution. She has been with the company for over 7 years and oversees the commercial growth development of the healthcare segment. She focuses on… […]
  • Women in Medtech 2021: Sarah Ehrlich, Argon Medical Devices Sustaining Mechanical Engineer
    Sarah Ehrlich, sustaining mechanical engineer at Argon Medical Devices, holds a B.S in mechanical engineering from the University of Texas at Tyler. “My parents knew I would become an engineer before I did,” she said. “Growing up, I was the big sister who put back together whatever my younger siblings decided to tear apart. I… […]
  • Four questions with AdvaMed’s Jen Brearey
    Jen Brearey is AdvaMed’s chief financial officer and chief operating officer, as well as executive director for the association’s inclusion diversity programs, which includes the industry initiative AdvaMed Advance and AdvaMed’s Women’s Executive Network. Ahead of our annual Women in Medtech edition of Medical Design & Outsourcing, we asked Brearey to share her expertise on gender… […]
  • Life Spine wins FDA clearance for ProLift micro expandable spacer
    Life Spine announced that it received FDA clearance to market its ProLift micro expandable spacer system for supporting micro-invasive procedures. Huntley, Illinois-based Life Spine designed its ProLift micro to support procedures ranging from endoscopic TLIFs to MIS TLIFs/PLIFs. The platform includes an 8mm width, self-locking expansion at any height (between 8mm and 16mm) to suit… […]
  • Achieve More with Medical Device Training and Certifications
    Any medical professional that deals with complex devices on a regular basis can benefit greatly from a wide range of medical device courses offered by The Center for Professional Innovation and Education (CfPIE). Each course offered is designed to advance your career under the instruction of trained, experienced, and actively practicing professionals in the field.… […]

Leave a Reply