Becton Dickinson lands clearance for 10-minute flu test | Regulatory Roundup

From Medical Design & Outsourcing

• HHS could make permanent pandemic-related exemptions for some devices
  HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process. In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided… […]
• Medtechs can’t set digital strategies aside – DTW Podcast
  Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck. In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices: Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical,… […]
• Protolabs to acquire 3D Hubs for up to $330M
  Protolabs (NYSE: PRLB) today announced it plans to acquire Amsterdam-based 3D Hubs, an online manufacturing platform that provides engineers with on-demand access to a global network of approximately 240 manufacturing partners. The transaction creates a comprehensive digital manufacturing offer for custom parts, expanding Protolabs’ breadth of capabilities as well as adding a broader offering of pricing and… […]
• These medtech stocks performed the best in 2020
  While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while… […]
• Covestro tests plastics against high-strength hospital disinfectants
  Covestro announced that it recently teamed with disinfectant manufacturer Metrex to test six different Covestro polycarbonate materials against three of Metrex’s products, which are widely used throughout the healthcare industry. As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were pre-strained and underwent several wipe-and-dry cycles with Metrex disinfectants to… […]
• Integer expands N.Y. battery plant
  Integer announced today that it recently broke ground on an expansion of its Alden, N.Y., facility to accommodate new equipment that will substantially increase the plant’s production capacity for rechargeable Xcellion lithium-ion batteries. The project kicked off in mid-December 2020 and will add both production equipment and a build-out of Integer’s existing facility. The company… […]
• Diversified Plastics adds high-efficiency vertical presses
  Diversified Plastics (DPI) announced that it recently installed six all-electric vertical injection molding presses. These presses will join DPI’s existing assemblage of vertical presses and provide increased production capacity to meet growing demand from medical device and other original equipment manufacturers (OEMs). DPI uses vertical presses for over-molding and insert-molding, capabilities often required for medical… […]
• Traco Power expands power supply line for portable medical equipment
  Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. Key approvals on the original series remain on the expanded… […]
• Reflow Medical launches low-profile reinforced support catheters
  Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with… […]
• Former CDER head Woodcock to lead FDA for now
  FDA veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports. An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not… […]
• What’s next for the FDA and for Stephen Hahn?
  Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year. It’s hard to blame him. Hahn’s brief tenure at FDA has been rocky, to say the least. (News of his temporary replacement broke on Thursday, when the incoming Biden administration… […]