Enteral Access Technologies (E.A.T.), a medical device company based in Liverpool, has received the CE Mark for its DoubleCHEK device, which enables the company to market the patient safety product in all EU countries.
George Gallagher, founder and CEO, said: “We are pleased to now be able to affix the CE Mark to our DoubleCHEK device. The team has worked hard to achieve this milestone, which gives our shareholders confidence that their belief in DoubleCHEK was well placed. This achievement, together with our UKCA Mark and application to US FDA for the 510(k), means the regulatory outlook for DoubleCHEK is excellent.”
The market opportunity for our product is now far greater and we are excited to now be able to take this patient safety technology to clinicians throughout Europe.”
The CE milestone comes after the company recently obtained a UKCA mark and signed an agreement with Medicina, a large healthcare distributor. It marks another achievement for the firm after securing funding in December. The certification opens up a market worth $1.3 billion by 2027.
Despite many complications for companies trying to export to Europe since Brexit, the E.A.T. team anticipate the high-impact nature of their device, together with its distribution agreements, will help it overcome trade barriers and see increased trade in a sector.
DoubleCHEK is an enteral feeding device that uses CO2 and pH indicators, coupled with a proprietary valving system, to help clinicians place naso/oro gastric tubes safely and quickly in any environment. Enteral feeding is used when patient cannot receive their nutrition orally.
Misplacement of feeding tubes can result in serious patient harm, and often happens because clinicians make decisions on placement with limited information.
It is estimated that 3–5 percent of all NG tubes inserted are misplaced into the airway, and approximately 33 percent of those misplacements result in serious morbidity, such as pneumonia or pneumothorax, or even death. DoubleCHEK provides clinicians with critical information to avoid NG tube misplacement.
Integer plans $30 million innovation and manufacturing facility in Galway
Integer Holdings, a medical device outsource (MDO) manufacturer, will further expand its presence in Galway with the construction of a new Medical Device Innovation and Manufacturing facility in the Parkmore East area of the city.
Plano, Texas–based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023 and equipment investments continuing for another two or three years.
Integer said it has planning permission for another 87,000 square feet of expansion when needed.
This new facility is required to meet increased demand for regional research, development and manufacturing capabilities, as well as capacity for catheters and delivery systems. It adds to Integer’s 15 global manufacturing sites and current presence in Ireland, which includes an R&D centre in Galway and manufacturing facilities in Galway and New Ross, County Wexford.
Tánaiste and minister for enterprise trade & employment Leo Varadkar TD, said: “I’m really pleased to see Integer announce further investment in Galway, with the addition of a new Medical Device Innovation and Manufacturing facility. I understand that this expansion will result in 100-200 new roles in the coming years, creating excellent employment opportunities for people in the area. This collaboration between IDA Ireland and Integer is another example of the valuable work that IDA Ireland does to bring investment into the country. I wish the team every success with this expansion.”
The expansion is expected to add 100 to 200 new jobs in engineering, administration and manufacturing, plus several hundred third-party contractors in the Galway region. Integer said it has around 1,300 employees in Ireland, including 350 in Galway.
The investment is being supported by the government through the IDA Ireland.
“Integer’s planned expansion in Galway is very welcome news,” said IDA Ireland CEO Martin Shanahan.
This is an important strategic move for the company, he noted, positioning it to meet growing demand globally for its products.
“This is a significant investment by a leading medical devices company and demonstrates Integer’s continued commitment to Galway and the West Region,” he added.”
The company, which has been in Ireland for over 25 years, currently employs approximately 1,300 people in Ireland, with 350 based in Galway.
FDA backs Pfizer-BioNTech COVID-19 booster for Americans with high-risk illness
The U.S. Food and Drug Administration (FDA) finally authorized on Wednesday Pfizer and BioNTech vaccine booster dose against COVID-19’s delta variant for Americans aged 65 and older with a high risk of grave illness.
While the dose will strictly involve a specific population group, boosters will be accessible to individuals between 18 and 64 years with health-threatening risks of extreme illness from the coronavirus. In parallel, the dose will be given to employees working in explicit establishments or hold certain job positions that might expose them to contracting severe COVID-19 complications, such as doctors and nurses, teachers, daycare employees, grocery workers, and people in homeless shelters.
According to the FDA’s statement, the third booster dose should be administered six months after the first two shots.
“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks said in a statement.
“We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines, and we will make further decisions as appropriate based on the data,” he added.
The FDA’s authorization will pave the way for what seems to be a complicated campaign to distribute the shots to the country’s most exposed and susceptible population, leading to potentially millions of Americans getting their vaccines at pharmacies, health clinics, and doctors’ offices.
While the administration endorsed the shots, Pfizer Inc. set safety and side effects measures by analyzing the booster’s effects in a clinical trial that involved 318 people.
During the clinical trial, the first category comprised of 306 individuals ranged between 18 and 55 years old while 12 people exceeded 65 years. The process took two months of monitoring while analyzing side effects such as pain, redness, swelling at the injection site, fatigue, headache, muscle and joint pain, and chills.
While the third Pfizer- BioNTech shot has similar side effects to the first two shots, the FDA disclosed that a set of participants frequently suffered from swollen lymph nodes in their underarms after receiving the booster shot.
The U.S. Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practice conducted a prolonged meeting on Wednesday to address collected data to analyze the effectiveness and assurance of the Pfizer-BioNTech third shot. While the committee has already studied the data, its final recommendation will be settled during its assemblage on Tuesday.
The FDA’s authorization will set the right framework for the Committee’s recommendations regarding boosters, as the CDC aims to make equitable approvals from a public health perspective, which in CDC’s advisors’ opinion should be based on preventing the intensity of the disease instead of aiming to prevent moderate infections.
As for the individuals who received a different vaccine, the FDA’s booster shot approval and the CDC’s data analysis will not refer to Moderna and Johnson & Johnson doses, as federal actions will take place in the upcoming weeks.
An FDA official, Doran Fink, engaged in CDC’s recommendatory meeting, disclosed that the federal agency does not have sufficient data to endorse the success and effectiveness of administering a Pfizer- BioNTech booster to individuals who got immunized with a different vaccine.
The FDA’s Wednesday authorization listed the U.S. as the world’s most prosperous nation to deliver booster doses, joining a league incorporating Germany, France, Israel, and the U.K.
While some public health specialists prefer if doses were sent to countries with lower vaccine rates, the Biden Administration pledged on Wednesday at a virtual COVID-19 summit to distribute an additional backup health package comprised of 500 million Pfizer doses to countries in need.
“We believe boosters have an important role in play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” chairman and chief executive of Pfizer, Albert Bourla said in a statement.
The vagueness following the CDC’s decision will linger until its meeting on Tuesday, while the FDA’s ruling could potentially detriment the Biden Administration’s scheme to distribute booster shoots to the majority of the country’s citizens.
Start-up develops “world’s first” tomographic ultrasound robot
Sydney-based medical device start-up Vexev has developed what it says is the world’s first tomographic ultrasound robot (TUR) to make diagnostics more affordable, accessible and insightful, after spending two years in stealth mode.
The primary method of diagnosis for cardiovascular disease is 2D ultrasound operated by a sonographer. Whilst 2D ultrasound is one of the most affordable imaging diagnostic modalities, and does not involve harmful radiation to the patient, it has several limitations – affordability, inconsistency and can only produce 2D scans.
Skilled sonographers are also increasingly in short demand, and their careers are often shortened by RSI due to years of operating 2D ultrasound machines.
The TUR will be tested in upcoming clinical trials at Sydney’s Eastern Suburbs Vascular Imaging, which is located at the Prince of Wales Hospital campus. The trials are supported by Australian vascular surgeons such as Dr Shannon Thomas, A/Prof Ramon Varcoe, Dr Andrew Lennox and Dr Tom Daly.
Matt Adams, senior vascular sonographer from the Australian Sonographers Association, said: “Vexev’s device has the potential to evolve the role of Vascular Sonographers, minimising low skill, high volume aspects of typical workflow. It may also assist in combating the well documented shortage of skilled Vascular Sonographers in the workforce, and high incidence of repetitive strain disorder. With extra time on their hands, this highly skilled group of healthcare professionals may have the chance to expand their scope of practice – whether that be in education, research or therapeutic intervention.”
Vexev’s technology is designed to automate the entire ultrasound procedure. Beyond increasing the efficiency and quality consistency of 2D ultrasound, the TUR aims to make diagnostics significantly more powerful by producing 3D tomographic ultrasound outputs (analogous to MRIs/CTs).
As a result, clinical settings where 2D ultrasound was previously uneconomical, such as dialysis clinics and regional clinics, can now adopt an imaging diagnostics capability. With Vexev’s device, sonographers will be able to produce 3D diagnostic outputs just like CT scan and MRI radiographers, complete more scans each day, and no longer suffer from high RSI incidence.
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