- My News
- All News
- Most Popular
A (sort of) silver lining from COVID-19 with MDR extension; test, test and more tests; clinical trials hit; a potential COVID-19 survivor - for now; car makers and answer to call for ventilator help.
COVID could bring extension to compliance period for new EU medtech rules
The new EU Medical Device Regulation (MDR) - the cause of much consternation among many medtech companies in the last three years - was to have come to force two months today on May 26, marking the end of the transition period in which manufacturers had to ensure their products were compliant to the new rules. In light of the disruption caused by the COVID-19 pandemic, the EU Commission is now proposing to Parliament and the EU Council to agree to a 12-month extension to the MDR enforcement date. EU Commissioner for Health and Food Safety Stella Kyriakides tweeted that "vital devices needed to treat #COVID19 patients must remain available in the EU markets", hence the proposal to delay implementation of the MDR. The new IVD Regulation (IVDR) has a longer transition period of five years, the deadline being 26 May 2022; the medical device trade federation MedTech Europe is also calling for a similar extension for the IVDR.
Test, test, test: COVID-19 diagnostics armoury expands
While the world waits for the pharma industry to come up with viable vaccines and antivirals to combat COVID-19, testing continues to be the key strategy for identifying those infected with SARS-CoV-2 and implementing measures to contain the spread of the virus. Since March 12, when the FDA granted Emergency Use Authorization to Roche’s COVID-19 test, the list of EUAs have expanded almost daily with 1-2 new additions and this week’s newcomers include Cepheid’s rapid point-of-care diagnostic. The test can generate results in less than one hour, faster than the other FDA authorised diagnostics. Furthermore, Cepheid - a Danaher company - has a large installed base of its analysers, especially in the US, which should facilitate accessibility and uptake of its tests [see The Wider View: Cepheid’s COVID-19 advantage isn’t just about speed for further analysis.]
COVID-19 hitting clinical trial progress
With more countries imposing stricter lockdown measures this past week in a bid to contain the spread of COVID-19, the impact of this on clinical trials are now being brought to greater relief. A couple of notable pharma names, including Eli Lilly, have announced they are postponing initiation of new trials and halting enrollment in ongoing studies, whilst several smaller medtech firms - fluid management tech company Sequana Medical and retinal implant specialist Pixium Vision, among others - have also recently made public that they will be facing delays to their clinical plans. CROs like ICON and PPD had already brought to light earlier this year how they were feeling the impact on their clinical work when the outbreak was still concentrated in Asia and only starting to move into Europe, particularly Italy. The restrictions on movement were not only affecting patient enrollment but also subject monitoring, they pointed out [see The Wider View: Trials in the time of COVID - the key challenges for further insight.]
Elective or essential? BrainsWay’s brainstim biz may survive through crisis
The halt on elective procedures are starting to hit certain medical device companies hard, particularly those whose products are not considered part of critical care, and investors are waiting to see what damage this is going to have on these businesses’ top-lines in the upcoming earnings season. But micro-cap company BrainsWay is showing that it doesn’t all have to be bad news. The firm recently released its fourth-quarter results and gave an optimistic outlook of its growth prospects for its transcranial magnetic stimulation (TMS) business. The company’s technology is designed to treat psychiatric disorders and it has US clearance for major depressive disorder and obsessive compulsive disorder. CEO Christopher Jako told investors this week that its clinics are viewing its deep TMS therapy as "essential treatment" and the majority are still operational, while taking extra precautions to ensure the safety of the patients [see The Wider View: Could BrainsWay be a surprise survivor of covid-19 fallout?]. If the crisis continues to escalate in the coming months and governments impose more draconian measures to contain the pandemic, BrainsWay’s outlook might be a lot less rosy.
Tesla, Ford, General Motors, Dyson chip in to help inflate ventilator supply
With the demand for critical care equipment to save seriously ill COVID-19 patients continuing to outstrip supply, medtech companies are joining forces with industrial manufacturers outside the realm of healthcare to help plug the gap. GE Healthcare this week said it is partnering with US automotive multinational Ford to scale the production of ventilators, while Medtronic has been in discussions with Tesla founder and billionaire, Elon Musk, to discuss this life-saving technology. While these talks have so far not led to any announcements about a partnership between these two companies, Musk tweeted that his company had acquired a surplus of ventilators - made by ResMed, Medtronic and Philips - from China and delivering them to US hospitals. In the UK, homegrown household appliance giant Dyson has said it is responding to the government’s call for more ventilators to combat the pandemic.
Did you like this article?