Medical Design and Outsourcing Archives - Page 153 of 154

Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement

Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time

As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech businesses, and their investors, need to develop their strategy for navigating their way through the evolving landscape.

In this 45-minute overview delivered by MCRA, the panel of experts in their specialties will dissect and discuss the ways which the regulatory, clinical and reimbursement pathways change and how you should be planning.

Attendees of this webinar will learn:

The impact of COVID-19 on clinical design and reimbursement The rise of telehealth and other digital health and how implementation of digital technologies could impact cardiovascular clinical studies The financial crunch and effect…

IMDRF recommends UL 2900 compliance for medical device cybersecurity

By Stewart Eisenhart, Emergo Group

Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

This patient-mover got an emergency COVID-19 nod from the FDA

The Patient Isolation Transportation Unit (PITU) [Image courtesy of AR Tech, a division of A&R Tarpaulins]

AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic.

“PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases a safer process,” said Carmen Weisbart, a registered nurse who is president of A&R Tarpaulins.

Get the full story on our sister site MassDevice.

GI Supply launches device to reduce necrotic tissue, pancreatic blood fluids

GI Supply recently launched its Piranha Aspiration Catheter for necrotic tissue suction.

The device is designed for better management of necrotizing pancreatitis for endoscopic transmural necrosectomy by improving the suction of necrotic tissue and pancreatic blood fluids.

Piranha LC suctions necrotic tissue and pancreatic blood fluids in the catheter to leave a clear visualization for a gastroenterologist.

Get the full story on our sister site, Medical Tubing + Extrusion.

Eudamed updates phased implementation for European medical device, IVD database

By Ronald Boumans, Emergo Group

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

When it comes to germicidal lights bought online, buyer beware

EE World brought out some testing equipment to evaluate germicidal lights [Image courtesy of EE World]

During the coronavirus pandemic, there’s been a lot of interest in using germicidal lamps to disinfect surfaces rather than hosing everything down with bleach or disinfectant. But there have been reports that a lot of the germicidal lights based on LEDs are actually fake. So we did a little test.

Our WTWH Media sister publication EE World went online and bought two germicidal lights, one based on a conventional low-pressure tube, the other which used LEDs. And we ran our test to see what we really had.

Check it out:

This textile coating could repel viruses like COVID-19

Researchers at the University of Pittsburgh have developed a washable textile coating that repels viruses.

Textiles and materials used in personal protective equipment can absorb and carry viruses and bacteria and spread diseases without the healthcare worker knowing. Because PPEs are in short supply during the COVID-19 pandemic, healthcare workers are finding ways to provide better protection while allowing for the safe reuse of the protective equipment, according to the LAMP Lab researchers at the university.

“Recently there’s been a focus on blood-repellent surfaces, and we were interested in achieving this with mechanical durability,” lead author of the study Anthony Galante said in a news release. “We want to push the boundary on what is possible with these types of surfaces, and especially given the current pandemic, we knew it’d be important to test against viruses.”

The coating is made to withstand ultrasonic washing, scru…

Medical device VCs give long-term pandemic perspectives

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and VytronUS (acquired).

Rohlen, who leads a holdings company backed by private eq…

Could face masks light up to detect COVID-19?

Researchers at Harvard University have developed a face mask with a sensor to detect COVID-19, according to a BusinessInsider report.

Wyss Institute researcher James Collins and his group developed a rapid self-activating COVID-19 diagnostic face mask. It can be worn by patients or people at home who have symptoms of coronavirus to quickly signal the presence of the virus without the need for hands-on manipulation, according to Harvard University.

Collins and the researchers suggest that patients can be easily triaged for proper medical care while healthcare workers and patients nearby are protected by using the diagnostic wearable.

The mask is made using highly sensitive molecular sensors coupled to synthetic biology networks and shows an immediately visible or florescent color signal when CoV2 is detected. It is cell-free molecular machinery that is freeze-dried and integrated with synthetic material on the interior of the face mask.

Once expose…

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…

Researchers develop 3D VR blood flow to improve cardiovascular care

[Image from Duke University]

Duke University engineers are developing a fluid dynamics simulator that models blood flow in the full human arterial system at a subcellular resolution.

The biomedical engineers hope the simulator will give doctors guidance in treatment plans by simulating specific vasculatures of patients to predict how stent placements, conduit insertions and other geometric alterations to blood flow can affect surgical outcomes.

Duke University researchers developed the tool, called Harvey, by exploring various interfaces ranging from standard desktop displays to immersive virtual reality experiences. They found that futuristic interfaces could be the key to widespread adoption of the technology.

“Harvey currently requires knowledge of C coding and command-line interfaces, which really limits who can use the program,” Amanda Randles, assistant professor of biomedical sc…

Webinar: Medical Power Backup – When is it essential?

Tuesday, June 9, 2020 2 p.m. eastern time / 11 a.m. pacific time

When it comes to medical devices, backup power is arguably more important than ever before as the COVID-19 pandemic stretches hospital resources to the breaking point. Our life sciences executive editor Chris Newmarker hosts experts from Astrodyne TDI as we explore the basics of medical device backup power. When is it useful? When is it a need? What are the best practices? What is trending?

Attendees of this webinar will learn how to:

Determine when to add mobile backup power; Use different methods for providing consistent power in the treatment room or operating room; Prioritize critical loads.

Featured Speakers:

Holly Remaly Strategic Marketing Astrodyne TDI

Chris Newmarker Executive Editor Medical Design & Outsourcing