Can Patches Improve Vaccination Rates?
Microneedle array patches (MAP), which have previously been used for cosmetics applications, are being considered for delivering a variety of vaccines. Earlier this year Harro Höfliger and PATH hosted a conference exploring such opportunities that drew representatives of the World Health Organization (WHO), UNICEF, the Bill & Melinda Gates Foundation, the Vaccine Alliance Gavi, and other researchers. The group is working to improve vaccination levels in low- and middle-income countries, particularly those for measles and rubella but also for other diseases, Stefan Bernsau, director, needle technology for H...
Source: MDDI - March 20, 2020 Category: Medical Devices Authors: Daphne Allen Tags: R & D Source Type: news
Abbott Brings Home EUA for COVID-19 Test
Abbott Laboratories, one of the biggest players in the medical device space, has obtained Emergency Use Authorization for a test to detect the coronavirus [COVID-19]. The Abbott Park, IL-based company joins the rapidly expanding list of companies that have received EUA designation in the past few days.
The firm’s RealTime SARS-CoV-2 EUA test can be used on its molecular instrument, the m2000 RealTime System, by authorized laboratories in the U.S.
"Our scientists, many of whom worked on Abbott's first HIV test and the Zika tests, worked around the clock to develop these molecular tests," Daman Kowalski, vi...
Source: MDDI - March 19, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Q4 Review: Takeaways from the Most Prominent Players in the Medical Device Industry
(Source: MDDI)
Source: MDDI - March 19, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Supplier Stories for the Week of March 15
(Source: MDDI)
Source: MDDI - March 19, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
Rapid Diagnostics Firm Secures Financing Amid Covid-19 Crisis
It might seem like the world has slowed down to a crawl amid the coronavirus (COVID-19) pandemic, but there are still some companies out there raising money. E25Bio is one of those companies – bringing in $2 million in funding from Khosla Ventures.
The Cambridge, MA-based company develops technology for rapid diagnosis of dangerous infectious diseases such as dengue, zika, and now COVID-19. Financing will go toward research and development, clinical studies, and scaling the company’s launch for diagnostic tests upon receiving Emergency Use Authorization approval.
E25Bio’...
Source: MDDI - March 19, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Is Your Ultrasound R & amp;D Team Exposed to Harm?
This article collates and simplifies the main points to the level of detail needed by a team manager. It also points to more in-depth resources for those who might need them.
Background on Ultrasound Physics
Firstly, let’s talk a bit about what an ultrasound machine actually does. Most ultrasound machines are diagnostic—they are intended to inform a healthcare practitioner of internal health issues not visible from the outside. Fun fact: the first ultrasound machines were actually developed for identifying flaws within metal beams, and medical applications came later.
Whether used for he...
Source: MDDI - March 19, 2020 Category: Medical Devices Authors: Nigel Syrotuck Tags: Electronics Source Type: news
What If We Couldn & #039;t Sue Our Doctors for Malpractice?
During childbirth, are doctors more likely or less likely to intervene surgically if liability is a concern? A study co-authored by an economist at Massachusetts of Technology (MIT) and a professor of law and economics at the Duke University, offers insight on this interesting question about "defensive medicine."
The research, based on evidence from the U.S. Military Health System, finds that when doctors have immunity from liability lawsuits, they actually perform slightly more C-section operations, compared to when they are legally liable for those operations — about 4% more, over a 10-year ...
Source: MDDI - March 18, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
BD Ramps Up Production, Collaborates on New Diagnostic in Response to COVID-19
BD (Becton, Dickinson and Company) was one of several medtech companies that joined President Donald Trump when he declared a national emergency last week. Several medtech executives detailed their response to the novel coronavirus (COVID-19) pandemic.
Tom Polen, BD’s CEO and president, reported during President Trump’s announcement that BD is “one of the leading providers of medical devices as well as collection products for testing of coronavirus and we are ramping up our manufacturing capacity to ensure that the right collection devices and testing equipment are read...
Source: MDDI - March 18, 2020 Category: Medical Devices Tags: IVD Source Type: news
The Biggest Threat to Medical Device Revenue Growth During the Pandemic
In a new report, Needham & Co.'s Mike Matson says he doesn't expect an economic slowdown to weigh directly on medtech growth, but that doesn't mean the industry will be unaffected by the coronavirus (COVID-19) pandemic.
"We think that the biggest threat to medtech revenue growth is a decline in elective procedures," the analyst said, adding that this trend is driven by hospitals cutting back on or stopping elective procedures as they prepare for and focus on COVID-19 patients, and by patients deferring elective procedures due to fears of exposure to the virus.
Both factors have already caused large declines in procedur...
Source: MDDI - March 18, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Head Mounted Displays Could Help People Overcome Glaucoma Challenges
A recent study from the Crabb Lab, at City, University of London shows how commercially available head-mounted displays (HMD) can be used to simulate the day-to-day challenges faced by people with glaucoma.
Twenty-two volunteers who did not have glaucoma took part in the study and wore an HMD while performing various tasks in either virtual or augmented reality. The study is published in the online journal, npj Digital Medicine. In the virtual reality task, participants were placed in a simulation of a typical, 'cluttered' house. Moving their eyes and head allowed them to look around it in order to find a mobile phone hidd...
Source: MDDI - March 17, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Digital Health R & Source Type: news
First Patient Enrolled in Post-Approval Study for HF Therapy
Impulse Dynamics has enrolled the first patient in a post-approval study of the Cardiac Contractility Modulation therapy, which is delivered by the Optimizer system. The move comes a few months after the private firm raised $80.3 million in a series D round.
The MT. Laurel, N.J.-based company said the post-approval study will evaluate the real-world evidence of the therapy’s safety and efficacy for three years. About 620 patients from heart centers across the U.S. will be enrolled in the study.
The first patient was enrolled by Charles Jost, M.D., interventional cardiologist and principal investigator at ...
Source: MDDI - March 17, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
Axonics Fires Back at Medtronic with Patent Review Challenge
In response to Medtronic's patent infringement claims, filed in November, Axonics Modulation Technologies is contesting the validity of each patent Medtronic has accused it of infringing.
Axonics said Monday that it is filing seven petitions before with the U.S. Patent and Trademark Office (USPTO) requesting an inter partes review (IPR) of each of the Medtronic patents in question.
“Since its inception in late 2013, Axonics has invested millions of dollars and thousands of hours into understanding the relevant and adjacent intellectual property landscape while developing our products and our o...
Source: MDDI - March 16, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
COVID-19 Puts the World Health Organization ’s Emergency Use Listing (EUL) to Work
The World Health Organization’s Emergency Use Listing (EUL) provides an approach for assessing medicines, vaccines, and diagnostics that could help address an outbreak classified by the WHO as a Public Health Emergency of International Concern (PHEIC). Robyn Meurant, executive director, regulatory services, IVDs and medical devices for NSF International, describes the EUL as “akin to the U.S. FDA’s Emergency Use Authorization†and says it could help countries that are “without great means to do testing.†...
Source: MDDI - March 16, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news
New Tests Enter the Scene as COVID-19 Rages On
Tests for the coronavirus (COVID-19) continue to roll in as the U.S. faces a public health crisis. Thermo Fisher Scientific and Mayo Clinic are the latest with diagnostic contributions.
Waltham, MA-based Thermo Fisher is the second company to be granted an Emergency Use Authorization for a commercially developed COVID-19 test. MD+DI reported Roche received this designation late last week too for the cobas SARA-COV-2 test.
In a press release, Thermo Fisher said the authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab...
Source: MDDI - March 16, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
Can Remote Patient Monitoring Curb COVID-19?
BioIntelliSense’s BioSticker wearable sensor for monitoring patient vital signs remotely could prove useful during the COVID-19 pandemic. FDA cleared early this year to continuously monitor a patient’s respiratory rate, heart rate, and skin temperature, BioSticker can now also measure the frequency of a patient's coughing, sneezing, and vomiting, Jim Mault, CEO of BioIntelliSense, told MD+DI. In addition, “the BioIntelliSense Data Service in combination with the FDA-cleared BioSticker remote monitoring device and 5G-enabled BioHub allows for continuous health data for e...
Source: MDDI - March 16, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news
