The U.K. Medicines and Health Care Products Regulatory Agency is in the thick of its proposed regulatory overhaul for medical technology, which the agency promises will hew closely to the regulations still in deployment in the European Union.
Europe may still await its first disease-modifying Alzheimer’s drug after the EMA postponed its decision on Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd) on March 22, but leading members of the World Dementia Council were in an optimistic mood when they convened in London four days later.
Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.
Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.
Johnson Matthey plc agreed to sell its medical device components business to Montagu Private Equity for £550 million ($700 million) on a cash-free, debt-free basis. For Montagu, the deal is part of its expanding health care portfolio. Earlier in 2024 the private equity firm, which is the primary shareholder in RTI Surgical Inc., acquired Cook Biotech Inc. from Cook Medical Inc. and merged the two companies.
Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.
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.
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