News and Resources from the WTWH Media Life Science Network - Page 966 of 968

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…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

RespiraWorks, ICS partner on inexpensive ventilator for developing countries

RespiraWorks. and Integrated Computer Solutions (ICS) announced a partnership to collaborate on the former’s open-source ventilator.

San Francisco-based Respiraworks touts the medical-grade device as capable of being assembled for less than $500. The company designed the system for long-term vs. crisis use and for developing countries with the intent to source and manufacture locally, according to a news release.

A volunteer group of mechanical, process, electrical and controls engineers formed RespiraWorks last month to combine their knowledge of life support and critical engineering applications amid the COVID-19 pandemic.

“While most teams are addressing the need for “bridge” type ventilators to keep someone alive for six to eight hours, we are not aware of any tackling the ventilators for longer-term needs in an open-source, supply chain-optimized manner, and that’s where this team provides value,” RespiraWorks founder Ethan Chaleff said in the…

FDA warns on accuracy of Abbott rapid COVID-19 test

Abbott’s ID Now test machine (Image from Abbott)

After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.

Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”

A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.

One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…

Boston Scientific prices $1.7b offering

Boston Scientific (NYSE:BSX) announced that it priced a public offering of senior notes under its shelf registration statement worth $1.7 billion.

Marlborough, Mass.-based Boston Scientific is offering $500 million in aggregate principal amount of 1.9% notes due in 2025, along with $1.2 billion in aggregate principal amount of 2.65% notes due in 2030.

The company expects the offering to close on May 18, subject to customary closing conditions, according to a news release.

Once it closes the offering, Boston Scientific said it plans to use the proceeds to refinance $450 million in borrowings under its revolving credit facility and a portion of its pre-payable bank debt, which includes $750 million under a $1 billion term loan credit facility maturing in 2021 and $500 million under a $1.25 billion term loan credit facility maturing in April 2021.

Barclays Capital, Citigroup, J.P. Morgan Securities and Wells Fargo Securities are acting as the joint b…

Allergan, Ideal Implant targets of FDA warning letters

The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.

One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.

Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre…

HHS announces $5 million award for COVID-19 research

The U.S. Health and Human Services Dept. announced today that it will offer a $5 million award this year to support research related to COVID-19.

The new funding opportunity announcement (FOA) is set to support novel, high-impact studies evaluating the responsiveness of healthcare delivery systems, healthcare professionals and the overall U.S. healthcare system amid the COVID-19 pandemic.

HHS announced the FOA through the Agency for Healthcare Research & Quality (AHRQ), which expects to invest the $5 million for new multi-method, rapid-cycle research with the ability to produce and disseminate initial observations within six months following the award, then regularly throughout the remainder of the award period.

AHRQ noted that the funding will support critical research focused on quality, safety and value of the health system’s response to COVID-19, the role of primary care practices and professionals during this pandemic, understanding how th…

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

Olympic Ophthalmics wins FDA nod for iTEAR100 neurostimulator

Olympic Ophthalmics announced today that it received FDA de novo clearance for its iTEAR100 neurostimulation technology for acute tear production.

The Issaquah, Wash.-based company’s prescription iTEAR100 system stimulates a cutaneous nerve to temporarily increase acute tear production in adults.

Olympic Ophthalmics’ neurostimulator is a stand-alone, pocket-size device that requires a 30-second-or-less application to the skin of the external nasal region. The application stimulates the trigeminal nerve to activate the parasympathetic nerve pathway that controls tear film homeostasis.

The company touted the system’s effectiveness in clinical trials and noted in a news release that the most common adverse effect observed was headache and dizziness, which occurred in 2%-3% of subjects.

“Olympic Ophthalmics is a team of entrepreneurs, clinicians, and investors with deep expertise in ophthalmology, neuromodulation, and medical d…

Ocutrx debuts AR-assisted surgery system

(Image from Ocutrx Vision Technologies)

Startup Ocutrx Vision Technologies (Irvine, Calif.) announced today that it is launching a new technology for surgery visualization.

The OR-Bot Surgery Visualization Theatre includes the ORLenz augmented reality (AR) surgery headset with three visualization options, depending on the surgeon’s preference:

A surgery view with augmented virtual patient and operating tool information. The choice of using an autostereoscopic “3D glasses-free” 3D 8K display monitor positioned directly in front of the surgeon. Viewing the surgery through a microscope-like VR viewing station positioned on one of the OR-Bot’s robotic arms.

Each surgery visualization choice provides a 4K resolution, according to Ocutrx. The OR-Bot’s arms are both human- and robotically controlled so doctors will be able to move the device’s gravity-compensated 6-axis arms with a slight touch while using…

Graham Engineering adds extrusion clamp

Extruder with AutoGrip clamp in foreground (Image from Graham Engineering)

Graham Engineering announced today that it has added a new extrusion clamp with electro-mechanical actuation to its American Kuhne product line.

The AutoGrip power clamp is safer and simpler to operate than manual devices and provides more repeatable clamping forces, according to York, Pa.-based Graham Engineering. It is designed to reduce downtime in installations with frequent screw, breaker plate, or tooling changes as well as to reduce the risk of injury or burns involved in manually releasing and tightening clamps during changeovers.

The AutoGrip clamp is remotely controlled by a two-hand pushbutton controller for user safety and convenience. The drive motor and gear box are mounted above the clamp, protecting them from melt residue and making them easy to access for maintenance.

“We have engineered the AutoGrip system with simplicity and safety in mind,” said Michael Duff, V…