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MedTech Europe: MDR hurdles persist as regulation takes effect

Karim Husami

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MedTech Europe MDR hurdles persist as regulation takes effect

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.

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Journalist for 7 years in print media, with a bachelor degree in Political Science and International Affairs. Masters in Media communications.

MedTech

AI cancer diagnosis platform receives FDA Designation

Karim Husami

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AI cancer diagnosis

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, which will help fast track the clinical review and regulatory approval of its platform.

Granting such approval is given to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases.

The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.

Oncology treatments

According to the National Cancer Institute, approximately 39.5 percent of men and women will be diagnosed with cancer at some point during their lifetimes (based on 2015–2017 data).

“In 2020, an estimated 16,850 children and adolescents ages 0 to 19 will be diagnosed with cancer and 1,730 will die of the disease,” the institute noted.

An estimated 1,806,590 new cases of cancer will be diagnosed in the United States in 2020, it noted, and 606,520 people will die from the disease.

“Oncology treatments have made great strides, but to save more lives it is also essential to see technological advances in cancer diagnostics. Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care,” David Shulkin, MD, advisor to Ibex Medical Analytics said.

AI cancer diagnosis platform role

“Ibex’s AI platform has demonstrated success in helping pathologists worldwide improve care for patients with cancer. This FDA designation is an important step forward in making this technology broadly available in the United States,” David added.

That said, pathologists play an important role in the detection and diagnosis of disease, with their assessment being vital for correct treatment decisions in cancer care.

However, a rise in cancer prevalence and advances in personalized medicine have resulted in growing diagnostic complexity that significantly increases pathologists’ workloads.

As such, Ibex’s Galen platform uses Strong AI algorithms to help pathologists improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time, and boost productivity. It has already demonstrated outstanding outcomes in clinical studies and is deployed in labs worldwide where it is used as part of everyday clinical practice.

Joseph Mossel, chief executive officer and co-founder of Ibex Medical Analytics, said: “We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world class tools for pathologists to ensure every patient receives a timely and correct diagnosis, while supporting pathology labs and health systems to increase efficiency and accuracy. Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continuing to collaborate with the agency as we accelerate our clinical program in the United States.”

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MedTech

Russia’s Sputnik V vaccine shows 94% efficacy in Bahrain

Inside Telecom Staff

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Sputnik-V

Controversy has been the main headline stuck to Russia’s Sputnik V COVID-19 vaccine, with many countries either doubting its efficacy levels or brushing it off due to political tensions between western countries and Russia.

In parallel, Russia hasn’t done a good job marketing the drug since it was named after the Soviet Union’s and the world’s first artificial satellite launched into space back in 1957.

But still the Russian vaccine persisted and remains to be administered to people all around the world as we speak.

With that in mind, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced on Thursday data of the Ministry of Health of the Kingdom of Bahrain on the Russian Sputnik V coronavirus vaccine confirming its safety and high efficacy during the vaccination campaign in the country.

The efficacy study was conducted in Bahrain in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3 percent.

Analysis is based on the data collected between February and early May 2021.

“Sputnik V has demonstrated efficacy of 94.3 percent and high safety confirming the data collected in a number of other countries where it is used to protect the population against coronavirus. The Russian vaccine is an important part of Bahrain’s diversified national portfolio. Use of Sputnik V is making a significant contribution in mitigating the spread of coronavirus, resuming normal life and economic activity,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said in a statement.

The data of the Ministry of Health also demonstrates that 98.6 percent of all COVID-19 cases 14 days after receiving the second dose were mild among those vaccinated with Sputnik V.

Vaccination data indicates high safety of Sputnik V:

  • No serious adverse events associated with vaccination;
  • No deaths related to the vaccination;
  • No cerebral vein thrombosis (CVT) cases after vaccination.

“Our data has confirmed the high efficacy and safety of Sputnik V during its use in Bahrain. This vaccine is one of a number of approved vaccines made available free of charge to citizens and residents in the Kingdom. Sputnik V continues to play an important role in the Kingdom’s ongoing and successful vaccination campaign, with 81 percent of the eligible population vaccinated so far,” Faeqa Saeed Al-Saleh, Bahrain’s Minister of Health, highlighted. 

Sputnik V has a number of key advantages:

  • Efficacy of Sputnik V is 97.6 percent based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020, to March 31, 2021;
  • The vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
  • Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
  • The safety, efficacy, and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
  • There are no strong allergies caused by Sputnik V.
  • The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
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MedTech

Orange, AXA acquire majority stake in Moroccan HealthTech company

Inside Telecom Staff

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HealthTech

Orange Middle East and Africa and AXA CIMA entities led by AXA Assurance Maroc announced on Monday a joint agreement to acquire a majority stake in DabaDoc, the Moroccan HealthTech company digitalizing access to healthcare in Africa, alongside the company’s founders.

DabaDoc – which was founded by Zineb Drissi-Kaitouni and Driss Drissi-Kaitouni earlier in 2014 – has developed solutions that are used by thousands of healthcare professionals in Morocco, Tunisia, and Algeria.

The agreement will allow both French companies to accelerate DabaDoc’s growth using their vast investment portfolios and network, particularly in Sub-Saharan Africa; the transaction is expected to close in the third quarter of 2021.

“As a responsible operator on the continent, we want to contribute to this major social challenge, especially during a pandemic. The deployment of this type of solution in the countries where we are present will greatly facilitate populations’ access to healthcare services, which is essential to the continent’s development,” Alioune Ndiaye, CEO of Orange Middle East and Africa, said in a joint statement.

With this acquisition, the French telco confirms its ambition of leading the line in multi-services digital operator in the region. Through its partnership with DabaDoc and relying on AXA’s globally recognized expertise in healthcare, Orange is positioned as a key player in HealthTech.

In parallel, this acquisition wouldn’t be the first investment AXA Assurance has placed in DabaDoc – with the first being in 2018 – but rather sends a message that the insurance company is looking to consolidate its partnership with the company to accelerate the digitalization and integration of its customers’ healthcare journey.

AXA will also aim to facilitate its policyholders’ interactions with healthcare professionals, notably via DabaDoc’s appointment booking and remote consultation infrastructure and network.

“This is one of the Group’s strategic priorities as part of the Driving Progress 2023 plan. This ambition is even stronger as we are facing an unprecedented health crisis. Through this partnership, we therefore aim to enable patients to access a better healthcare journey in Morocco and to support DabaDoc through its development in the CIMA countries as well,” Meryem Chami, CEO of AXA Assurance Maroc and AXA CIMA, highlighted.

In cementing this tri-party partnership, DabaDoc will benefit from the broad experience of AXA, one of the global leaders in health insurance, and Orange’s technological expertise and payment solutions to enable digital solutions to be developed that rapidly scale and benefit patients and the entire African healthcare ecosystem.

“Orange’s investment in DabaDoc and AXA’s renewed investment will strengthen DabaDoc’s growth ambitions through Orange and AXA’s presence in Africa and the Middle East. The pandemic has strengthened our belief that the digitalization of healthcare services is essential and inevitable,” Zineb Drissi-Kaitouni, co-founder and CEO of DabaDoc, noted in the statement.

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