PerkinElmer Joins the COVID-19 Antibody Test Conversation with EUA
The story for the diagnostics industry in March and April was FDA’s Emergency Use Authorization of multiple tests to detect the novel coronavirus (COVID-19).
The conversation is now shifting to SARS-CoV-2 antibody testing. PerkinElmer’s EUROIMMUN division is the latest to add to the narrative as it has received EUA for its Anti-SARS-CoV-2 ELISA (IgG) serology test.
The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. PerkinElmer said the Â&...
Source: MDDI - May 5, 2020 Category: Medical Devices Tags: COVID-19 IVD Source Type: news
Best Practices for Human-Centric Design of Medical Devices
Medical devices designed to accommodate human variability present a growing opportunity for the healthcare and life sciences industries. Historically, medicine has solved many of the “simple†issues first: how to fix a broken leg has been known for centuries! But today we have treatments that didn’t even exist a generation ago, such as the use of stents and replacement valves for heart disease. These devices address a more limited cohort of people and are most successful when designed to be patient-specific. The cohorts themselves must also be further defined to account...
Source: MDDI - May 5, 2020 Category: Medical Devices Authors: Kristian Debus Tags: Design Source Type: news
Bringing Point-of-Care Testing to Consumer End-Points
The medical diagnostics industry has been moving steadily from centralized testing toward a decentralized model that brings testing ever closer to the patient. The benefits of point-of-care (POC) interventions are significant, and new technologies have expanded the options of home testing, while new generations of testing kits offer enhanced accuracy, reliability, and speed.
Detection and monitoring are especially critical for diseases such as HIV, Hepatitis C (HVC), and colon cancer, and POC technologies can encourage early detection and better testing compliance as they are more accessible for patients. They are also les...
Source: MDDI - May 4, 2020 Category: Medical Devices Authors: Maria De Capua Tags: IVD Source Type: news
FDA Officials on COVID-19 Tests: Flexibility Never Meant We Would Allow Fraud
As the diagnostic community shifts its attention SARS-CoV-2Â antibody testing, FDA flags a concerning number of COVID-19 antibody tests marketed under false and inappropriate claims.
In response, the agency this week revised its March 16 policy, which has served as a regulatory roadmap for COVID-19 antibody tests, also known as serology tests. The revision comes about two weeks after FDA issued a warning to healthcare providers about the limitations of such tests.
"In mid-March, it was critical for the FDA to provide regulatory flexibility f...
Source: MDDI - May 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news
High Demand Caused by COVID-19 Helps Baxter Beat 1Q20 Expectations
Baxter International is experiencing significant revenue growth because of the novel coronavirus (COVID-19). Because of the virus’s impact, the Deerfield, IL-based company beat Wall Street expectations for its 1Q20 earnings.
Baxter reported results of $2.8 billion, a 6% increase from the $2.6 billion reported in 1Q19. The results beat out consensus, which came in at about $2.7 billion.
Higher demand for Baxter’s continuous renal placement therapy line, generic injectables and parenteral nutrition therapies, and intravenous solutions contributed to sales growth. Executives estimated that ...
Source: MDDI - May 4, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Business Source Type: news
Roche Scores EUA for COVID-19 Antibody Test
There were some pretty significant developments in the world of COVID-19 that occurred over the weekend. One of these developments was Roche Diagnostics being granted Emergency Use Authorization (EUA) for the Elecsys Anti-SARS-CoV-2 antibody test.
The antibody or serology test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.
Roche said it has already started shipping the new antibody test to laboratories worldwide and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in count...
Source: MDDI - May 4, 2020 Category: Medical Devices Tags: COVID-19 IVD Source Type: news
The Time is Ripe for an Alternative to Automated Hazardous Drug Compounding
Conclusion
Compounding safety standards have increased in recent years, after much research and education and as governing bodies have championed the use of better and more rigorous safety equipment such as CSTDs. The next step for compounding will be the common use of automation, which must include CSTDs as a central part of the compounding process. This should be used in tandem with current protective principles for manual compounding to guarantee that healthcare workers and patients alike are kept safe, while simultaneously increasing productivity and lowering overall cost.
 (Source: MDDI)
Source: MDDI - May 4, 2020 Category: Medical Devices Authors: Marino Kriheli Tags: Filters & Filtration Materials Source Type: news
Supplier Stories for the Week of April 26
(Source: MDDI)
Source: MDDI - May 1, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
New Acquisition Could Give Abiomed Access to Help COVID-19 Patients
Abiomed, maker of the Impella heart pump, could have the chance to reach some COVID-19 patients with its latest acquisition.
The Danvers, MA-based company said it acquired Breethe, a developer of an extracorporeal membrane oxygenation system for an undisclosed sum.
Breethe has applied for a 510K clearance of the ECMO system. The Baltimore, MD-based company’s technology has the potential to serve the needs of patients whose lungs can longer provide sufficient oxygenation, including patients suffering from cardiogenic shock, cardiac arrest or respiratory failure such as due to ARDS, H1N1, SARS, or COVID-19....
Source: MDDI - May 1, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Cardiovascular Source Type: news
Medtech in a Minute: Another Deal Bites the Dust, Telemedicine Changes the Game, and More
Another Deal Bites the Dust
Citing a negative market impact from COVID-19, Alphatec backed out of its agreement to acquire EOS Imaging. While the deal is no longer feasible as contemplated, Alphatec said it is open to a strategic collaboration, if EOS is willing. Earlier this month, Organovo killed a proposed merger with Tarveda Therapeutics, but not because of the pandemic. That decision was prompted by indecisive scientific data on Organovo's part.
Telemedicine Is Changing the Diabetes Game
Telemedicine is emerging as the hero technology during COVID-19. In the diabetes space, the technology is enabling new patient acces...
Source: MDDI - April 30, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Feds Take Pandemic Profiteering Seriously
The United States goverment is taking a hard look at companies that may be unethically profiting from the COVID-19 pandemic. This week a federal court in Utah entered an injunction halting the sale of various silver products that were being promoted as coronavirus treatments.
FDA’s Office of Criminal Investigations and Office of the Chief Counsel worked with the U.S. Department of Justice on the complaint.
“The FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped,â€Â said Judy McMeekin, FDA A...
Source: MDDI - April 30, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news
Dexcom Patients Will Have Longer Wait for G7 as COVID-19 Disrupts Pivotal Trial
COVID-19 is creating much uncertainty across the medical device industry, both in terms of revenue guidance and in terms of clinical trial timing. For Dexcom, that uncertainty will directly impact the timing of the company's latest continuous glucose monitoring (CGM) sensor, the G7.
"We remain confident in our ability to deliver G7, but acknowledge that the timing of the pivotal trial will be delayed due to the pausing of new trials at most clinical sites," Dexcom CEO Kevin Sayer said during the company's first-quarter earnings call, according to SeekingAlpha transcripts.
Sayer said the company currently expects COVID-19 t...
Source: MDDI - April 30, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Employing AI and Remote Patient Monitoring in the Fight Against COVID-19
A new collaboration between Current Health and Mayo Clinic will combine artificial intelligence and remote patient management to tackle the novel coronavirus (COVID-19).
Edinburgh-based Current Health said the collaboration is aimed at accelerating the identification of COVID-19-positive patients and predict symptom and disease severity in patients, healthcare workers, and other at-risk individuals in critical service sectors.
To do this, digital biomarkers collected by Current Health’s FDA-cleared remote monitoring sensors and platform will be used.
"We currently help manage care for hundreds of patients...
Source: MDDI - April 30, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Business Source Type: news
Telemedicine Is Changing the Game in Diabetes Management
There was a lot to unpack from Dexcom's first-quarter earnings call this week, but one of the key takeaways from management comments is that diabetes patients and caregivers are latching onto telemedicine as a way to stay on top of their glucose levels during COVID-19. This isn't surprising, given that we've seen a substantial increase in telemedicine adoption across healthcare during this crisis, but it is especially important for newly diagnosed patients needing continuous glucose monitoring (CGM) technology.
"Our extensive virtual resources for patient and clinician training and customer support are proving to be especi...
Source: MDDI - April 29, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Digital Health Source Type: news
Supporting Agile Scale Ups During COVID-19 Medical Supplies Shortage
With the COVID-19 pandemic creating shortages of crucial products and equipment, ATS Automation Tooling Systems Inc. has stepped up to assist medical device manufacturers in scaling up production of these critical devices. ATS is also working to enable manufacturers in other industries to quickly pivot to making products used in treating or diagnosing the disease.
With more than 40 years in business, roughly 55 percent in life sciences, ATS has experience in manufacturing medical devices requiring the highest product quality. “This is the world we live in—we are used to this...
Source: MDDI - April 29, 2020 Category: Medical Devices Authors: Susan Shepard Tags: Assembly and Automation Source Type: news
