11 innovative medical devices you need to know from 2018

From Medical Design & Outsourcing

• Intertek gains FDA nod for premarket device testing
  Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week. The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market. The Accreditation Scheme for Conformity Assessment pilot program is a voluntary program developed to provide increased confidence in testing… […]
• HHS shoots down ‘flawed’ plan to let some devices skip review
  The Biden administration has nixed a ‘flawed’ Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review. HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing… […]
• More than 50 medtech testing sites win FDA pilot accreditation
  The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews. In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market… […]
• Medline Industries up for sale?
  Medline Industries is looking for a buyer in a deal that could be worth $30 billion, according to a report in the Wall Street Journal. The Journal cites “people familiar with the matter” saying that Northfield, Ill.-based Medline has hired Goldman Sachs to manage the process. The people added that the company might alternatively seek… […]
• Micro to add plant in Costa Rica
  Contract manufacturer Micro today announced plans to open a new plant in Costa Rica. The 32,000 ft² facility will significantly increase Micro’s cleanroom assembly capacity, according to the Somerset, N.J.-based company. It will be located in the Zona Franca Metro business park and is expected to open in late 2021 with operations beginning in 2022.… […]
• Survey shows solid medical device industry performance despite pandemic
  By Stewart Eisenhart, Emergo Group Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not… […]
• Cardinal Health wins $58M federal PPE contract
  Cardinal Health (NYSE: CAH) today said it has won a $57.8 million contract from the U.S. Dept. of Health and Human Services to support the Strategic National Stockpile. The Dublin, Ohio-based company received the contract, which includes options that if exercised by the HHS could reach $91.6 million, to store and distribute 80,000 pallets of… […]
• Qosina adds single-use bioprocessing devices
  Qosina this week launched its product line for the single-use bioprocess industry. The new product line includes tube-to-tube bard connectors, luer fittings, check valves, tubing pinch clamps, tubing, steam thru connectors and more. Get the full story on our sister site, Medical Tubing + Extrusion. The post Qosina adds single-use bioprocessing devices appeared first on […]
• Could BrainCheck’s simple test help COVID long-haulers?
  BrainCheck‘s eponymous mobile neurocognitive test can detect dementia and concussion. But it has a new application: post-COVID brain fog. Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop… […]
• XL Precision Technologies holding an April 28 webinar about laser tech
  XL Precision Technologies is holding an online webinar on April 28 at 8 a.m. Eastern time (1 p.m. U.K. time) about laser technology in medical device manufacturing. Register for the webinar here: https://bit.ly/XL-MER-Webinar2 Stockton-on-Tees, U.K.–based XL Precision Technologies provides laser welding, laser cutting of fine tubes and flat material and laser etching of components. It’s… […]
• Medical device companies put $3.6 billion in docs’ pockets, study finds
  Medtech companies paid $3.62 billion for access to physicians — 10% more than drug companies did — from 2014 to 2017, according to new research. Device company payments to surgical specialists were significantly more tied to the surgeons’ Medicare billing than payments from drug companies to specialists, according to the study, which appears in the… […]