MedTech Europe has been warning for quite some time about Medical Device Regulation (MDR)’s potential to disrupt product supply due to issues around the ability of the EU’s infrastructure to ensure a smooth transition when the rules came into force on May 26.
With a few days having passed by the set date, the trade group is once again warning that significant challenges remain unresolved that could negatively impact the sector.
As such, MedTech Europe warned in a statement that hurdles remain limiting the industry’s ability to “seamlessly supply certified devices under the new rules.”
Some of the challenges that are hindering the successful deployment of the new regulatory system include: non-harmonized interpretation and application of MDR rules across the EU; limited capacity among notified bodies, especially for certification of new and innovative devices; uncertainties with regards to pending discussions on the rules and agreements between the EU and other countries such as Switzerland; and unpredictable recognition of MDR certifications at the international level vis-à-vis regulatory approvals from other jurisdictions.
“Such challenges need ongoing attention and work by the EU Commission and Member States, if Europe is to ensure a workable system in the long-term,” MedTech Europe said.
The European trade group argues that despite the MDR going into effect, “some key pillars” of the necessary infrastructure are “still not fully operational or even in place,” creating challenges in particular for many small and medium enterprises.
CEO Serge Bernasconi argued the complexity of MDR and the delay in the new regulatory system’s full readiness is resulting in European patients “losing their previous opportunities to be the first to benefit from critical medical technology innovation.”
The group added that it is working with the EU and stakeholders to “rapidly propose solutions to avoid disruptions” in supply of medical devices and diagnostics.
Vista Equity invests $300 million in telehealth software firm TigerConnect- sources
Healthcare communications software provider TigerConnect has raised $300 million in growth investment from private equity firm Vista Equity Partners, sources familiar with the matter told Reuters on Monday.
The valuation of TigerConnect wasn’t known. It last raised $45 million at a valuation of $370 million in September 2020, according to PitchBook data, counting HealthQuest Capital and New Leaf Ventures as its backers. Some of the early investors have exited through Vista’s investment, one of the sources said.
Santa Monica, California-based TigerConnect delivers cloud-based clinical communication and collaboration solutions, including telehealth, to over 7,000 healthcare organizations and 700,000 caregivers.
In an interview, Brad Brooks, TigerConnect’s co-founder and chief executive confirmed the partnership with Vista, but declined to comment on the amount or valuation.
He said the company plans to use the proceeds to invest in its product to meet the growing need for clinical collaborations, as well as looking for acquisition opportunities.
The number of users on TigerConnect’s platform more than doubled during the past year as hospitals try to improve efficiency and the experience for patients during the pandemic, Brooks added.
“There had really been a dramatic lack of efforts around clinical workflow communication. We’re almost like a Slack for healthcare, putting in a common communication network so that everyone can reach everyone,” said Brooks.
The company, founded in 2010, sells subscription-based software solutions, including collaboration, communication, scheduling and patient engagement. It also plans to utilize AI and machine learning technology to provide smart solutions based on the platform data.
Vista has over $86 billion in assets under management and specializes in investing in enterprise software, data and technology companies. Last week, it invested an undisclosed amount in BlueConic, a Boston-based customer data platform.
AstraZeneca booster shot is effective against Omicron variant
A study from an Oxford University lab published on Thursday revealed that a three-dose course of AstraZeneca booster shot is efficient in controlling the fast spread of the Omicron variant.
The Pharmaceutical company said in its statement that the results – while they have yet to be released in a peer-reviewed medical journal – are relatively identical to those of its rivals, including Pfizer-BioNTech and Moderna. They also uncovered that their booster vaccines effectively fight the latest Coronavirus variant.
After receiving the third dose of AstraZeneca, the study highlighted that the shot had a neutralizing effect against the virus, which had an almost identical result to the two shots against its previous variant, Delta.
“As we better understand Omicron, we believe we will find T-cell response provides durable protection against severe disease and hospitalizations,” the head of AstraZeneca’s biopharmaceutical R&D, Mene Pangalos, said when referring to a significant element of the immune system that fights infection.
After taking the Vaxzervria – the third booster shot – antibody levels marked a much higher rate than antibodies in patients who had already caught the virus and naturally regained health, the Anglo-Swedish drugmaker said.
On Tuesday, the pharmaceutical firm announced that it is already working with its partner, Oxford University, to develop a vaccine exclusively directed towards fighting the Omicron variant, mirroring other MedTech companies’ attempts.
The university’s study incorporated 41 samples from individuals who had already taken the first two shots of AstraZeneca and others who took the booster one. The lab examined and analyzed blood samples from people infected with the virus and others vaccinated with the two dozes, the third booster shot, and finally, those who had already caught one of the coronavirus variants.
It is worth mentioning that AstraZeneca stated that while the Oxford University lab results support its booster shot, the study was completely independent of researchers who had previously joint efforts with the London-based firm on the vaccine.
The world is looking to halt back from the detrimental effect the pandemic is spreading, with governments and scientists seeking to heighten fortifications in their health sectors against the Omicron.
Even since its emergence on the scene, the latest COVID-19 variant proved to be one of the most dominant variants to date. Governments are worried it might become globally spread after the holidays if they fail to curb the infections rate.
Earlier this month, the UK endorsed third shots after discovering that boosters have a vital role in restoring protection against other diseases triggered by the Omicron.
Moderna, unfazed by Omicron, prepares for 2022 vaccination campaign
Covid-19 vaccine-making veteran Moderna seems unfazed by the emergence of the Omicron variant, saying that they can begin work on developing a booster short within a couple of weeks, according to Chief Executive Stephane Bancel.
“It only needs minor adjustments for Omicron, I don’t expect any problems,” said Bancel in an interview with the Swiss newspaper TagesAnzeiger.
Though hoping to begin clinical trials in early 2022, for the time being, they will be relying on the booster dose of their mRNA-1273 vaccine to counter the fast-spreading coronavirus variant.
The company is now awaiting vital information on the new variant to begin vaccine development, which could take up to one or two weeks.
Bancel says that it will take another few months to produce 500 million doses after all the regulatory requirements have been met, citing that their capabilities and experience as a company today have increased compared to one year ago.
In 2021, Moderna managed to create around 700 million to 800 million vaccine doses. In 2022, they expect to escalate production capacity from 100 million doses per month to 150 million per month.
Deals were also made with Swiss-based drug manufacturer Lonza to boost production further and plan to fire up their factory lines in the first quarter of 2022.
The company is currently discussing a future ‘vaccine subscription’ service with Switzerland that works to ensure a steady supply. This move helps improve ties with the country, which Moderna is keen to proceed with after signing parliamentary agreements with Canada and Australia.
“We have a number of new vaccines in development, for example against influenza or against the RS virus, which causes a respiratory disease that is fatal in the elderly and young children,” Bancel added.
“We can combine these three mRNA vaccines into one dose and propose to governments to secure supplies for a certain amount for several years and then invest in a production facility in that country,” he added.
With this, the company can designate certain countries as having priority should another pandemic occur in the future.
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