People Want More Control over the Use of Their Genetic Data
Researchers from Penn State and Cornell University conducted a survey that shows as people become more aware of privacy concerns and the ways in which genomic database companies are profiting from their data, their expectations for compensation and control may increase.
The researchers created a survey based on in-depth field interviews with officials and employees who were involved in genomic governance at 12 different organizations. They recruited 2,020 participants - representative of the U.S. population - through Qualtrics to participate in the survey and provided them with mainstream media coverage of genomic database...
Source: MDDI - March 16, 2020 Category: Medical Devices Authors: MDDI Staff Tags: R & D Source Type: news
Medtech in a Minute: The Latest on How Coronavirus Is Impacting the Industry
FDA Halts Foreign Inspections
In a rare action that is sure to impact medical device application reviews, FDA suspended inspections outside the United States through April in response to the coronavirus pandemic. The decision was based on government travel advisories, access restrictions imposed on foreign visitors by certain countries, and the importance of the health and safety of agency employees.
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Diagnostics Companies Leap into ActionÂ
Becton Dickinson and Company (BD), CerTest Biotech, Qiagen, Quest Diagnostics, Laboratory Corporatio...
Source: MDDI - March 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business IVD Source Type: news
Chembio and Lumira to Develop POC Tests in the ‘Heat’ of COVID-19 Outbreak
Chembio Diagnostics has enlisted LumiraDx to develop point-of-care tests for the detection of the coronavirus (COVID-19). Demand for COVID-19 diagnostics is at a fever-pitch in the US as there is a huge struggle to get the tests into the healthcare system.
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Gail Page, Chembio Diagnostics’s interim president and CEO went in more detail about working with Waltham, MA-based LumiraDx during a call with investors. Page said the diagnostics developed in the collaboration would be used on both the LumiraDx and Chembio DPP platforms.
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“This expands and strengthens our e...
Source: MDDI - March 13, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Business Source Type: news
Medical Equipment Manufacturer Increases Production to Meet Demand Driven by COVID-19 Pandemic
This week, the World Health Organization declared a worldwide pandemic of COVID-19. In the United States alone, the Centers for Disease Control and Prevention (CDC) predicts that patients as well as healthcare workers might need as many as 100- to 400-million surgical masks as well as 7,000 to 11,000 mechanical ventilators in the coming days to help prevent the disease from spreading and to treat them if they become infected.
Steve Heffernen, president of Omnimed, worries that medical equipment manufacturers might have difficulty keeping up with such increased demand. “It changes e...
Source: MDDI - March 13, 2020 Category: Medical Devices Authors: Susan Shepard Tags: Business Source Type: news
Top 10 Patient Safety Concerns in 2020
(Source: MDDI)
Source: MDDI - March 13, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business IVD Source Type: news
Thermo Fisher Gets into Companion Diagnostic Collaboration with Janssen
Thermo Fisher Scientific has signed an agreement with Janssen Biotech to co-develop a companion diagnostic in the oncology space. Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The pact calls for both firms to work together to validate multiple biomarkers for use with Waltham, MA-based Thermo Fisher’s Oncomine Dx Target Test, which will be used to identify variant-positive patients for enrollment into clinical trials focused on non-small cell lung cancer. Right now, the Oncomine assay contains 46 cancer-related biomarkers.
"The ability of the Oncomine Dx Target Te...
Source: MDDI - March 12, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Supplier Stories for the Week of March 8
(Source: MDDI)
Source: MDDI - March 12, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
StreamOne R from PAXXUS Wins Several Awards
StreamOne R Retortable Recycle-Ready Polyester from PAXXUS has been recognized in the Flexible Packaging Association’s annual competition with several awards: a gold award in sustainability, a gold award in technical innovation, and a silver award in packaging excellence.
“Receiving multiple FPA awards for StreamOne R is the ultimate validation of PAXXUS’s long-term commitment toward developing leading edge technology for the evolving circular economy,†Dwane Hahn, vice president of sales and marketing for PAXXUS, told MD+DI.
Originally des...
Source: MDDI - March 12, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news
Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices
Reggie Dye went 15 years without seeing a physician, in part because he had always been incredibly healthy. He regularly does high-intensity worksouts, enjoys hiking, golf, and can't remember the last time he even had a cold. But a preventative health evaluation incentive program his company offered in 2016 taught him that even the healthiest individuals are not immune to prostate cancer.
After two prostate-specific antigen (PSA) screening tests, followed by additional testing, Dye was diagnosed with localized prostate cancer. At first, he was given the choice of active surveillance, als...
Source: MDDI - March 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
New Financing Could Help BillionToOne Expand Product Offerings
BillionToOne wants to expand its diagnostic offerings and its most recent financing could give it a push in that direction. The Menlo Park, CA-based company has raised $15 million in a follow-on to its series A round.
With this financing, the company BillionToOne has brought in more than $32.5 million. The private company noted previous investors, Hummingbird Ventures and NeoTribe Ventures led the investment round with participation from Y Combinator, Libertus Capital, Pacific 8 Ventures, Civilization Ventures, 500 Startups Istanbul, and HOF Capital.
BillionToOne said it will use the proceeds to support the commercial expa...
Source: MDDI - March 11, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news
FDA Suspends Inspections Outside of the US Due to Coronavirus Outbreak
FDA is suspending its inspections outside of the US through April in response to the coronavirus (COVID-19) pandemic.
Inspections outside of the U.S. would be deemed “mission-critical†and would be considered on a case-by-case basis. The measure would be effective immediately.
In a release, FDA Commissioner Stephen Hahn, MD said, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep ...
Source: MDDI - March 11, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Source Type: news
More Tests on the Way as Coronavirus Spreads
As the coronavirus continues to spread, companies are ramping up efforts to develop diagnostics. The latest diagnostic comes from CerTest Biotec and Franklin Lakes, NJ-based Becton Dickinson and Company (BD). The duo announced Tuesday the VIASURE SARS-CoV-2 Real-Time Polymerase Chain Reaction (PCR) Detection Kit had been adapted for the BD Max System and won CE mark for use in Europe.
In a release, the companies said the VIASURE SARS-CoV-2 Real-Time PCR Detection Kit is a real-time reverse transcriptase PCR assay for use on the fully automated BD Max System. It detects SARS-CoV-2 in clinical samples by amplification of a f...
Source: MDDI - March 10, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news
How Healthy Is Medical Innovation in the NHS?
The United Kingdom's Medicines and Medical Devices Bill was a key item of healthcare legislation outlined in the Queen’s Speech in December. As well as setting out new regulations for medical devices such as pacemakers, breast implants, and ultrasound imagers, it aims to reduce general practitioner (GP) appointments by increasing the range of professions able to prescribe medicines in low-risk circumstances. It also paves the way for National Health Service (NHS) hospitals to use innovative, personalized medicines for unique cancers and diseases.
Health Minister Baroness Nicola Blackwood stated her determ...
Source: MDDI - March 10, 2020 Category: Medical Devices Authors: Barbara Harpham Tags: Regulatory and Compliance Source Type: news
Even More Conferences Canceled Over Coronavirus Concerns
The Joint meeting of the American College of Cardiology’s and World Congress of Cardiology (ACC.20/WCC)is the latest medtech/pharma conference to be canceled over concerns of the spread of the coronavirus (COVID-19). The event was slated to occur March 28-30.
Instead, the organization said virtual options for science and award presentations will be announced in the coming days.
"The health, safety, and well-being of our members, staff, exhibitors, faculty and other stakeholders is of paramount importance," ACC President Richard J. Kovacs, MD, FACC, said in a release. "With an ever-increasing number of ACC...
Source: MDDI - March 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
NeuroPace Removes Barrier for Epilepsy Treatment Through FDA Nod
NeuroPace is spicing up the neuromodulation market a bit with a new nod from FDA for MRI labeling for the RNS system. The Mountain View, CA-based company’s RNS System treats patients living with seizures that do not respond to medication and first landed a PMA in November of 2013.
In a release, the company said individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option.
The company added this will also a...
Source: MDDI - March 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Regulatory and Compliance Source Type: news
