Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
With a waiting list of some 90,000 people, startup company Charco Neurotech Ltd. is seeing growing demand for its Cue1 device which has shown to reduce the symptoms of Parkinson’s disease in patients suffering from the condition. The Cue1 is a non-invasive device that can literally change the day-to-day lives of people living with Parkinson's, Lucy Jung, CEO and co-founder of Charco, told BioWorld.
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.
Choosing blastocysts for transfer based on size could give prospective parents a much better chance of success in welcoming a new member to the family, a study published in the Nature portfolio journal Scientific Reports demonstrates.
The U.K. government continues to pump money into research projects focusing on the use of artificial intelligence (AI) in health care as it looks to technology to help diagnose and treat patients. It provided £2 million (US$2.5 million) in funding to test innovative ways to tackle cancers with poor survival rates.
AI-Stroke SAS is developing an artificial intelligence (AI)-based application able to detect strokes in real time using a simple smartphone or a tablet. The med-tech firm has just won an award in the i-Lab 2023 innovation competition, supported by the French Ministry of Research and sovereign bank Bpifrance SA. “We use the latest AI and computer vision technology to replicate a neurologist’s expertise immediately anywhere, whereas non-specialists can make diagnostic errors up to 50% of the time,” Cédric Javault, CEO and co-founder of AI-Stroke SAS, told BioWorld.
Israel’s venture capital firm Pitango has raised $175 million for a new fund focused on backing entrepreneurs leveraging data science, artificial intelligence (AI), medical devices and novel biology to transform health care. Pitango Healthtech II is the firm’s second fund dedicated to health care and will see investment go into 15 companies ranging from those at the seed stage to those wanting commercial stage investment.
Amber Therapeutics Ltd. has acquired Bioinduction Ltd. as well as its neuromodulation therapy platform, Picostim Dyneumo. Amber is currently using the platform, an implantable system to deliver its closed-loop therapy for mixed urinary incontinence, Amber-UI, in a first-in-human study. With early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy, it made sense to acquire the hardware which allows for the therapy to work, CEO Aidan Crawley, CEO and co-founder of Amber told BioWorld.
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
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