MassDevice

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

Home » The top 5 MassDevice stories of the week — December 11, 2020

The top 5 MassDevice stories of the week — December 11, 2020

By

MassDevice Top Five medtech stories weekThe medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more.

This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat.

Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” — as well as play some drum and bugle corps music — during our DeviceTalks Weekly podcast.

Without further ado, here’s this week’s MassDevice Top Five:

5. FDA authorizes at-home COVID+flu test from Quest Diagnostics

The FDA has given emergency use authorization for a COVID-19 and flu combination diagnostic from  Quest Diagnostics (NYSE:DGX). Quest’s test detects and differentiates nucleic acid from the viruses through nasal swab specimens collected at home by individuals for whom home collection is deemed appropriate by a healthcare provider. Read the full story.

4. FDA says Pfizer’s COVID-19 vaccine meets success criteria

The FDA said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets its success criteria ahead of this week’s critical advisory meeting which could see the vaccine move toward emergency authorization.

According to the FDA, the vaccine offered protection after the first dose, while two doses — required by Pfizer about three weeks apart — were “highly effective” in preventing confirmed COVID-19 infection at least seven days after the second dose. Read the full story.

3. Biden makes picks for HHS secretary, CDC director

President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden is unveiling his plan for his administration and for the handling of the COVID-19 pandemic, but has not yet chosen a nominee for the role of FDA commissioner. Read the full story.

2. Boston Scientific gains FDA nod for SCS

Boston Scientific (NYSE:BSX) announced that it received FDA approval for its WaveWriter Alpha spinal cord stimulator systems. The company touts the system as the only SCS portfolio that can layer paraesthesia and paraesthesia-free options simultaneously, supporting up to 32 contacts targeting specific nerves along the spinal cord. Read the full story.

1. Court confirms $112M Medtronic loss in royalties spat

An appeals court in Indiana upheld a $112 million jury award in favor of a local spine surgeon turned medical device inventor in his seven-year royalties dispute with Medtronic (NYSE:MDT). A three-judge panel let stand a $112,452,269 verdict in favor of Dr. Rick Sasso, who sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop. Read the full story.

In case you missed it

RSS From Medical Design & Outsourcing

  • 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… […]
  • Medicare to cover breakthrough devices
    FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices… […]
  • FDA debuts plan for AI-based Software as a Medical Device
    The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD). The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” It outlines five actions that the FDA… […]
  • EU allows remote audits for medical devices during pandemic
    The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic… […]