The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices granted market access under the legacy system. MDCG has clarified that these devices will be subject to postmarket surveillance requirements under the MDR system rather than the previous system, although it is not a simple process to determine when this approach does and does not apply.
PARIS – Incepto Medical SAS, in partnership with Marie-Lannelongue Hospital, is developing an automated system to measure maximum aorta diameter. Called ARVA (Augmented Radiology for Vascular Aneurysm), it’s hosted in the cloud and is CE marked as a class I device. “Our tool uses the first algorithm to provide automatic measurement of external aortic diameter along the entire aorta, from ascending aorta to the iliac arteries,” Antoine Jomier, co-founder and CEO of Incepto, told BioWorld. This new tool for radiologists and surgeons will be used to diagnosis and monitor aneurysms.
PARIS – Bone 3D SAS has signed a partnership with Stratasys Ltd. to put 3D printing technology directly into the hands of all 3,000 French hospitals and their front-line medical professionals. This new service, called Hospifactory, makes it possible to leverage additive manufacturing to produce medical equipment and devices directly on site at the hospital.
A research report by global investment bank Jefferies has found increased investor optimism in the health care market amid COVID-19, with respondents expecting stocks to rise throughout 2022. The Jefferies Healthcare Temperature Check summarizes the views of 500 leaders across the health care sector. Sixty percent of respondents said they believed the MSCI World Health Care Index would be higher by the end of 2022 than at present.
LONDON – Intensive monitoring of health care workers at two hospitals in London showed that despite having a blood biomarker of infection, 58 of them did not test positive for COVID-19 at any point, suggesting they may have been clearing subclinical infections before seroconversion.
PARIS – Royal Philips NV has signed a deal to acquire Cardiologs Technologies SAS and its artificial intelligence technology. The financial terms surrounding the transaction have not been disclosed. The two companies expect to close the deal in the coming months.
LONDON – A pilot study has shown that whole genome sequencing can pinpoint the genetic causes of rare diseases, even in people who had previously not been given a diagnosis after undergoing sequencing of their protein coding exome.
PARIS – The French National Agency for the Safety of Medicinal and Healthcare Products (ANSM), has published its latest annual report on the drugs and medical devices market in France. This body, placed under the supervision of the Ministry of Health, is responsible for monitoring all healthcare products throughout their cycle, for collating and analyzing reports of adverse reactions, and for implementing corrective action across the nation.
Investors have injected $8.4 million into Swedish startup Sigrid Therapeutics AB to speed development of its oral medical device Sipore15. The technology is a tasteless and odorless white powder taken with water to reduce blood sugar levels in people at risk of developing diabetes.
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.