FDA approves LDR’s cervical disc replacement device

From Medical Design & Outsourcing

• MedCrypt acquires MedISAO in medtech cybersecurity deal
  Healthcare cybersecurity company MedCrypt (San Diego) today announced the acquisition of Irvine, Calif.-based MedISAO, a cybersecurity information-sharing organization that works with the medical device industry. MedCrypt is now offering MedISAO’s information-sharing analysis network for small and midsize business as well as its Cyber Protek software bill of materials (SBoM) and dependency vulnerability management tool. MedISAO’s… […]
• The top digital health startups in the world
  About two-fifths of the startups in CB Insights’ second annual Digital Health 150 list are engaged in telehealth, a high-demand area amid the COVID-19 pandemic. That is one of the big takeaways from the list of 150 promising digital health startups that CB Insights released today. CB Insights’ research team picked the 150 startups after… […]
• Report: BD, Quidel struggle to supply antigen tests for COVID-19
  Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal. The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep… […]
• Nortech Systems closing one plant, selling two others
  Nortech Systems (NSDQ:NSYS) announced this week that it will shutter one manufacturing plant and sell two others to lease them back following a tough year for the business. Maple Grove, Minn.-based Nortech said Tuesday that it will close its plant in Merrifield, Minn., by December 31, 2020, and offer that plant’s 60 employees jobs at its… […]
• CMS proposes coverage updates that could increase access to VADs
  The Centers for Medicare & Medicaid Services (CMS) today proposed coverage policy updates meant to increase access to VADs and artificial hearts. The policy updates, if approved, could be good news for major VAD makers Abbott (NYSE:ABT)  and Medtronic (NYSE:MDT) — as well as people with heart failure who are waiting for a heart transplant or don’t… […]
• Exceeding regulatory requirements: Beyond the checklist
  Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks. Sherry Parker, WuXi AppTec Between the EU Medical Device Regulation (MDR) delay and other regulatory bodies shifting priorities due to COVID-19, manufacturers are… […]
• FDA medical device user fees to increase 7% in 2021
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans a 7% medical device user fee increases for the 2021 fiscal year, raising costs slightly for premarket submissions including 510(k) Premarket Notifications, Premarket Authorizations (PMA) and De Novo requests for classification. Get the full story here at the Emergo Group’s blog. The opinions… […]
• MedAcuity advising Ventilator Project on software
  MedAcuity Software (Westford, Mass.) announced today that it has volunteered to provide technical software assessment for The Ventilator Project, a non-profit working on developing a low-cost ventilator specifically for COVID-19 patients. Founded in March 2020 by entrepreneur Tyler Mantel of Watertower Robotics, The Ventilator Project has built a team of more than 250 volunteers from… […]
• Hologic applies for pooled COVID-19 testing nod
  Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July,… […]
• Canon Medical launches mobile digital X-ray platform
  Canon Medical Systems USA announced that it has launched a mobile digital X-ray system designed to streamline bedside exams to help improve workflow and productivity. The FDA 510(k)-cleared Soltus 500 has a compact design with features that promote efficiency and patient safety, without compromising image quality. They include: Intuitive tubehead controls, including an 8.4-in. touchscreen… […]
• Electronic Valve Technology
  The following is an overview of different technologies available when selecting the correct electronic valve for your application. Spider Valve Technology Invented and patented by Clippard, this deceptively simple design features only one moving part with a mere 0.007″ of travel. The spider is an armature spring that undergoes a variety of proprietary processes, including… […]