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.
The U.K. Medicines and Healthcare products Agency (MHRA) is to stop carrying out its own appraisals of drugs that are being reviewed by the U.S. FDA, the EMA or Japan’s PDMA, and will instead set up “global recognition routes,” through which companies can apply to place products on the U.K. market that have passed regulatory scrutiny elsewhere.
Seamless Therapeutics GmbH raised $12.5 million in seed financing to take forward a novel gene editing technology based on reprogramming recombinase enzymes.
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.
The U.K. arm of Silicon Valley Bank (SVB) is to be acquired by HSBC UK Bank plc for a symbolic £1, after senior ministers and the Bank of England worked all weekend on a rescue package. The acquisition is to complete immediately, averting what the U.K. government had acknowledged would be a crisis for the biotech and tech sector.
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.