All articles by Staff Writer
Staff Writer
LDT rule change sparks Backlash
Earlier this year, and following a similar move on the other side of the Atlantic, the FDA finalised new rules around laboratory-developed tests, bringing in vitro diagnostics under the definition of medical devices. Arguing that stricter enforcement is necessary – not least when 70% of medical decisions rely on diagnostic tests – it has come up against vocal opposition and a challenge in court. Jim Banks talks to legal and laboratory testing experts to assess the impact of these seemingly burdensome new rules.
How CMOs can catch the eye
Until quite recently, CMOs did what they said on the tin: manufactured devices or components for OEMs. But as competition soars, contract manufacturers must distinguish themselves from rivals. Jim Banks talks to experts across the sector to find out how CMOs can stand out from the crowd, and whether so-called ‘value-added’ services are the key to success.
ZwickRoell and Cormica MET Announce Strategic Partnership to Enhance Development Support for Early-Stage Innovations.
ZwickRoell and Cormica MET have partnered to offer support and expertise in developing equipment and testing protocols for medical device testing.
BioStem Announces Notice of Allowance for U.S. Patent Application for Sterile Human Placental Allografts
Company continues to advance its placental-derived product portfolio with the first patent granted in the fenestrated wound care market
Keystone Electronics PTFE Insulated Terminals & Pins
New Hyde Park, NY… Press-in type PTFE (Teflon) Insulated Terminals for high temperature and high-quality terminal and connector applications are part of the Keystone Electronics family of Multi-Purpose Hardware.
3rd Medical Device Software Development Summit Europe
The 3rd Medical Device Software Development Summit Europe – coming to Munich, 27-29 January, 2025 – is your one stop shop for cutting-edge case studies and strategic insights on designing, validating, and maintaining compliant and robust medical device software.
Klöckner Pentaplast Launches kpNext® MDR1: Sustainable Medical Device Packaging Film
Klöckner Pentaplast (kp), a global leader in sustainable protective packaging, is proud to announce the launch of kpNext® MDR1, a new medical device packaging film that expands its kpNext® brand beyond pharmaceutical blister films and into the medical device sector. This breakthrough product is designed to meet the growing demand for sustainable packaging options in healthcare packaging.
Improving long-term medical implants: better mechanical performance with 3D printable carbon-fiber reinforced PEEK filaments
Smart biomaterials, due to their innate adaptability to ever-changing stimuli, are becoming increasingly used for better patient-specific care in the medical world. Applications are especially common in the field of long-term medical implants, where the chosen material needs to have outstanding biocompatibility, biostability, and sterilizability.
COMPAMED 2024: Enablers of progress in medical technology to exhibit
Many innovative developments at show — with accompanying programme of on-stage events on full range of supplier-related trending topics
ALBIS and Röhm expand partnership: ALBIS granted extended distribution rights for PLEXIGLAS® and PLEXIMID®
ALBIS, a leading distributor of thermoplastic polymers, and Röhm, a major global provider of methacrylic products and intermediates, are expanding their successful partnership. As of October 1, 2024, ALBIS receives additional distribution rights for PLEXIGLAS® and PLEXIMID® molding compounds in the Scandinavian regions (Denmark, Finland, Norway, Sweden) and the Baltics (Estonia, Latvia, Lithuania). Previously, the cooperation between ALBIS and Röhm has covered the markets of Turkey and North Africa.