The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
At the European Congress of Radiology 2023 in Vienna, a session was devoted to photon-counting CT (PCCT). A team of five clinical researchers from Germany, Ireland, Norway, the Czech Republic and Slovakia spent an hour presenting an update on the latest clinical progress for this new medical imaging technology.
Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for products already on the market. However, manufacturers that wish to obtain a new certificate for their legacy devices still have a lot of work to do as they must file at least a preliminary application for these devices with a notified body (NB) by May 26, 2024, not a mean feat given the crunch on notified bodies operating in the EU.
Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
Perspectum Ltd. raised $19 million in the second close of its series C funding round bringing the total amount raised in the round to $55 million. The fundraising was led by Oppenheimer & Co. Inc., which sees the potential for long-term growth in Perspectum’s imaging and diagnostic technologies and invested $27 million.
Just three months after raising $12.9 million, Remedee Labs SAS reported it has signed a partnership with pharmaceutical group Upsa SAS to ramp commercialization of its smart bracelet for chronic pain. “We are going to rapidly deploy our non-invasive chronic pain relief technology throughout France and Europe,” David Crouzier, co-founder and CEO of Remedee Labs, told BioWorld.
United Imaging Healthcare Co. Ltd. (UIH) presented its Umr Jupiter 5.0T scanner at the European Congress of Radiology in Vienna. This new ultra-high-field 5 Tesla MRI scanner supports exclusive whole-body clinical and research applications.
Implantica AG reported that the first two Refluxstop procedures to treat acid reflux have been performed at Getafe University Hospital in Spain. Trial results indicate that the single-use passive medical implant can cure reflux in 98% of cases without the need for medication.
Startup Metsystem ApS received €500,000 (US$529,080) from Denmark’s Bioinnovation Institute (BII) that will allow the company to conduct trials to validate its personalized prognosis platform for cancer metastasis. An organ-specific assessment of the metastasis potential of a patient’s primary tumor would enable clinicians to better balance the trade-off between providing the potentially life-extending benefit of preventative chemotherapy to those at higher risk and avoiding the adverse effects from chemotherapy in those who are unlikely to need it.
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