MassDevice Archives - Page 587 of 587 - Medical Design Sourcing

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…

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…

Gilead licenses remdesivir production to 5 generic drugmakers

(Image from Gilead Sciences)

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.

Remdesivir is an intravenous drug that…

Could COVID-19 be telehealth’s big moment?

Frost & Sullivan announced today that recent analysis finds that the demand for telehealth technology is expected to rise amid the COVID-19 pandemic.

The analysis, titled “Telehealth — A Technology-Based Weapon in the War Against the Coronavirus, 2020,” revealed that, as COVID-19 continues to disrupt the practice of medicine and the delivery of healthcare, the U.S. telehealth market will experience seven-fold growth by 2025.

Get the full story at our sister site, Medical Design & Outsourcing.

Philips lands 510(k) to market ultrasound systems for COVID-19

The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications.

Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips.

The 510(k) clearance, which Philips called an industry first, allows the Netherlands-based company to provide detailed, practical guidance to support clinicians using its systems and software for COVID-19 patients. The clearance applies to Philips’ EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLAB advanced quantification software.

Ultrasound has shown value in imaging peripheral lung tissue affected by pneumonia, which is closely tied to COVID-19 lung complications, according to Philips. As …

DexCom prices $1.05B ‘upsized’ offering

Continuous glucose monitoring system developer Dexcom (NSDQ:DXCM) announced today that it priced an upsized offering worth $1.05 billion in convertible senior notes.

Yesterday, the San Diego-based company announced an offering worth $850 million with plans to offer note purchasers a 13-day option to buy up to an additional $150 million aggregate principal amount of notes. Today, DexCom increased the aggregate principal amount and granted a 13-day option to purchase up to an additional $157.5 million in notes.

DexCom is offering senior, unsecured obligations with an interest rate of 0.25% per year. The notes will mature on Nov. 15, 2025. The company expects the sale of the notes to close on May 14, 2020, according to a news release.

Before 5 p.m. ET on the business day immediately preceding Aug. 15, 2025, the notes will be convertible at the option of the holders. Upon conversion, they may be settled in shares of DexCom’s common stock, cash, or a co…

Ultimate Guide to a Digitized Shop Floor

As Industry 4.0 initiatives and digital transformation efforts get off the ground, ongoing advances in Industrial Internet of Things, artificial intelligence and robotic process automation are making their mark on everything from product assembly to quality inspection to equipment maintenance and even good manufacturing practice (GMP) documentation. It’s no wonder that leading manufacturing companies today are focusing heavily on fully digitizing and integrating information technology and operational technology capabilities. The biggest change in manufacturing is taking place right on your shop floor.

Download our Ultimate Guide and see the exciting results offered by new innovations and how digitizing your shop floor can revolutionize your manufacturing operations.

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