Med-tech deal value in February jumped to $255.61 million, an increase of 137.23% from the $107.75 million in deals from January, yet below the 2023 monthly average of $886.13 million. On the M&A front, med-tech transactions hit their lowest point since May 2019, totaling only $16 million.
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.
The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
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.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
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