Endotheia Inc. reported the successful completion of a first-in-human clinical trial of its steerable technology for endoscopic surgery. The single-use device integrates with standard forward-viewing gastroscopes, allowing physicians to replicate the functions of specialized duodenoscopes that are currently used in the treatment of biliary disease.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
Organox Ltd. raised £25 million (US$33 million) in a funding round that will allow the company to expand its operations in the U.S. on the back of significantly increasing demand from transplant centers, Oern Stuge, executive chairman, at Organox told BioWorld. The Oxford, U.K.-based company which makes systems to preserve and transport livers for transplant is also preparing for its eventual listing on Nasdaq, he added.
A study conducted by Cognito Therapeutics Inc. demonstrated significant changes in white matter volume and myelination in patients with Alzheimer’s disease after six months of at-home, non-invasive gamma stimulation therapy in a presentation at the Alzheimer’s Association International Conference 2023.
Astek Diagnostics Inc. has wound up a successful $2 million early stage VC funding round to support the development and launch of a medical device designed for the speedy recovery of patients suffering from urinary tract infections (UTI). The Baltimore-based startup has designed a benchtop analyzer and disposable cartridge called the Jiddu that can detect bacterial infection in urine in one hour.
The €5.5 million (US$6 million) Escala Medical Ltd. recently received from the European Innovation Council will help the company expand its operations as it looks to officially launch its Apyx device in the U.S. later this year, CEO and founder Edit Goldberg told BioWorld. Already FDA-cleared, Apyx offers incision-free pelvic organ prolapse (POP) treatment to the women suffering from the often painful and debilitating condition.
The mortality rate of patients with kidney failure can be significantly reduced if they are treated with high-dose hemodiafiltration compared with the more commonly used high-flux hemodialysis, according to a study recently published in the New England Journal of Medicine. The results from the CONVINCE trial pave the way for the increased adoption of hemodiafiltration as a therapeutic option to treat patients with end-stage kidney disease.
As it develops a new metastasis-on-a-chip device based on microfluidic chip technology that provides a platform to capture and study highly metastatic cancer cells, Mettactics Ltd. is in the process of raising financing to develop its product to empower precision medicine. Founded in 2019, Hong Kong-based Mettactics developed a microfluidic device that can capture metastatic cells and carry out clinical tests to predict the drug response of patients based on the cells’ genetic signature.
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.