Join Us Tuesday on Facebook Live
Grab a cup of coffee (or other favorite morning beverage) and join News Editor Amanda Pedersen for the first of a new Facebook Live series. Click here to go right to it. You can even go there now to set a reminder for Tuesday.
We'll chat about current events impacting professionals in the medical device industry. Feel free to use the chat box to ask questions during the live feed or to suggest future topics. (Source: MDDI)
Source: MDDI - April 3, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Medtech in a Minute: Abbott & #039;s COVID Test, Pay Cuts at Boston Sci, and More
Abbott Brings Rapid Testing to the Front Lines
Tthe new five-minute test is the second Abbott test to receive emergency use authorization by FDA for COVID-19 detection. Combined, Abbott expects to produce about 5 million tests a month. While developing new molecular tests normally takes years, Abbott's scientists worked around the clock to compress the timeframe down to weeks for the ID NOW COVID-19 test.
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Boston Scientific Cuts Pay and Withdraws Revenue Guidance
Boston Scientific is "significantly reducing" the salaries of its CEO, board of directors, and executive committe...
Source: MDDI - April 3, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Mardil Medical Treats 3rd Patient in FMR Trial
There’s no doubt mostly everything has been put on pause as a response to the coronavirus outbreak. However, even as the virus is taking top priority in healthcare, there are still some clinical trials unrelated to the pandemic that are making progress.
Recently, cardiovascular specialist Mardil Medical completed the treatment of a third patient in its clinical trial to treat Type IIIB Functional Mitral Valve Regurgitation (FMR) with an improved VenTouch.
The Minneapolis, MN-based company’s device is a minimally invasive option and combination therapy that simultaneously treats the disto...
Source: MDDI - April 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
Siemens Developing New Diagnostic for COVID-19
Siemens Healthineers is adding more firepower in the fight to make more novel coronavirus (SARS-CoV-2) diagnostics available.
The company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only (RUO) to expedite availability while it continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use.
In addition, the company is in talks with FDA to release the test under Emergency Use Authorization (EUA). Siemens said while these measures are in effect it also expanding its production capacity.
Siemens inherited t...
Source: MDDI - April 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Adopting X-Ray Sterilization for Medical Devices
The use of X-rays as an alternative modality to either gamma irradiation or electron beam irradiation for the sterilization of medical devices has become a topical subject over the last two or three years. The drivers are the improved capability of modern-day X-ray generation systems and a desire to develop a range of competitive and sustainable sterilization technologies. The Panel on Gamma and Electron Irradiation has compiled a short guidance document on the steps required when switching radiation sterilization technology, for example, from gamma or electron beam to X-ray. The guidance clarifies the requirements of ISO ...
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Steve Sugden Tags: Sterilization Source Type: news
Liquid Biopsy Test Detects More than 50 Cancer Types
Grail has some solid results coming from its multi-cancer early detection blood test. The liquid biopsy specialist revealed data that shows its technology can detect more than 50 cancer types across all stages, with a very low false-positive rate of less than 1%, through a single blood draw.
These results were published in Annals of Oncology. Grail’s Circulating Cell-Free Genome Atlas (CCGA) study provided much of the data for the publication. The study included more than 15,000 participants with or without a diagnosis of cancer.
In the sub-study reported in Annals of Oncology (N=6,689), results from the ...
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Supplier Stories for the Week of March 29
(Source: MDDI)
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news
COVID-19 Could Hurt Orthopedic Companies in More Ways than One
Any medical procedure that can be deffered until after the coronavirus pandemic is over will be. That means lower procedure volumes for hospitals and medical practices, which translates into lower revenue for medical device companies. One sector of the industry that stands to be heavily impacted by this is orthopedics.
Canaccord Genuity analyst Kyle Rose surveyed orthopedic/spine surgeons to assess the impact on treatment patterns and practice viability. As expected, most of the 50 respondents (60%) said their organizations were defering or postponing all procedures, and about a third of respondents...
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news
Boston Scientific Cuts Pay and Withdraws Revenue Guidance
As expected, medical device companies are feeling the financial impact of the new coronavirus – and it's only going to get worse.
Boston Scientific was already expecting the virus to lower first-quarter revenue by $10 million to $40,000 as early as Feb. 5, when the company hosted it's last earnings call. Then, as COVID-19 reached a global pandemic level in March, procedure volumes took a nose dive. The Marlborough, MA-based company now expects first quarter 2020 revenue growth to be flat to "up slightly" compared to first quarter 2019 revenue, and an organic...
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
COVID-19 Could Hurt Orthopedics Companies in More Ways than One
Any medical procedure that can be deffered until after the coronavirus pandemic is over will be. That means lower procedure volumes for hospitals and medical practices, which translates into lower revenue for medical device companies. One sector of the industry that stands to be heavily impacted by this is orthopedics.
Canaccord Genuity analyst Kyle Rose surveyed orthopedic/spine surgeons to assess the impact on treatment patterns and practice viability. As expected, most of the 50 respondents (60%) said their organizations were defering or postponing all procedures, and about a third of respondents...
Source: MDDI - April 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news
Healthcare Tech Company Nets $13M for Faster, More Accessible COVID-19 Test
A small San Diego, CA-based company has joined the ongoing battle against the new coronavirus.
Cue Medical secured a U.S. government contract to deliver its portable point-of-care diagnostic test for the detection of SARS-Cov-2, the virus that causes COVID-19, into the hands of the public. The U.S. Department of Health and Human Services Biomedical Advanced Research and Development authority awarded the $13 million contract.
The Cue system is designed to be affordable, portable, and able to operate in the home - a true consumer diagnostic device, according to the company.&Ac...
Source: MDDI - April 1, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news
S+N Lands Contract to Produce OxVent Ventilators on a Large Scale
Smith+Nephew has been contracted by the UK government to build OxVent ventilators to help in the treatment of coronavirus(SARS-CoV-2). The London-based company said the OxVent ventilator is currently under review by the Medicines and Healthcare products Regulatory Authority (MHRA) and the order is subject to the design gaining authorization.
The device was the result of a collaboration of scientists, clinicians and medical technology manufacturers from the University of Oxford, King’s College London and Smith+Nephew. Â
The company is supporting the assessment process and preparing for manufact...
Source: MDDI - April 1, 2020 Category: Medical Devices Authors: Omar Ford Tags: Contract Manufacturing Business Source Type: news
Abbott Brings Rapid Testing to the Front Lines
Abbott’s new ID NOW COVID-19 test, which earned emergency use authorization (EUA) from FDA last week, was highlighted during President Donald Trump’s COVID-19 taskforce press briefing on March 30. FDA Commissioner Stephen Hahn spoke about the rapid approval of Abbott’s point-of-care test for COVID-19.
“Normally these tests take months to develop,†Hahn noted during the briefing. “I was on the phone today with the Abbott CEO who told me this is normally a 9- to 12-month approach to developing a point-of-care test. The...
Source: MDDI - April 1, 2020 Category: Medical Devices Authors: Daphne Allen Tags: IVD Source Type: news
Is Second Sight Closing up Shop?
Second Sight Medical Products is the latest medtech company to face tough losses as a result of the financial impact of the novel coronavirus (SARS-CoV-2). The Sylmar, CA-based company is laying off 84 of its 108 employees and said it intends to wind-down operations.
The firm develops implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals. FDA greenlit the Argus II retinal prosthesis system in 2013.
Plans now call for the Second Sight to retain an adviser experienced in winding down operations to guide the board on the next steps. Any wind down activity, if impl...
Source: MDDI - March 31, 2020 Category: Medical Devices Authors: Omar Ford Tags: Implants Business Source Type: news
Developing Raw Technology
During the MD&M Minneapolis 2019 conference, Perry Parendo of Perry's Solutions spoke about best project management practices for engineers. Afterward, a sidebar conversation began regarding new technology exploration. MD+DI asked Parendo a few questions on how engineers could approach what he calls “raw technology.â€
Do engineers employed by medical device companies have enough time and internal support to develop raw technology? If not, what are some best practices to better support such work?
Parendo: Time available really depends on the company. A start up needs cash flow, so it c...
Source: MDDI - March 31, 2020 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis Design Source Type: news
