An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
Techbio specialist Relation Therapeutics Ltd has raised $35 million in new seed funding, bringing total seed money to $60 million, as it advances development of its in silico/wet lab platform for identifying drug targets in the non-coding parts of the genome. The company is building a “lab in the loop” system where in depth ‘omics profiles of single cells from fresh patient tissues are analyzed by its machine learning engine to uncover the genetic basis of clinical phenotypes and identify novel targets.
Thermology Health Ltd. is looking to raise £3 million to £4 million (US$3.8 million to US$5 million) to help bring its thermal imaging technology to patients to better diagnose and prevent diabetic foot ulcers, Yuval Yashiv, CEO told BioWorld. The company’s AI-driven remote patient monitoring platform measures the temperature of the skin on the foot and detects whether an ulcer is forming, thereby preventing thousands of foot amputations and significantly reducing health care costs, said Yashiv.
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
Advanced Medical Solutions Group plc (AMS) signed an agreement to buy Peters Surgical SAS for up to €141.4 million (US$154.6 million). The move by AMS for the tissue repair and skin closure manufacturer is part of its strategy to buy assets which will strengthen its product portfolio and broaden its global reach.
Another med-tech acquisition was wiped off the charts after Japan’s Olympus Corp. rescinded the acquisition of South Korean medical device firm Taewoong Medical Co. Ltd. on March 7, after finding “data integrity issues” related to Taewoong’s products.
Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.
The U.K. government said it will take action to tackle potential bias in the design and use of medical devices after an independent review found that there is extensive evidence of poorer performance of certain technologies, like pulse oximeters, in patients with darker skin tones.
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