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 U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
Adicon Holdings Ltd. raised HK$409 million (US$52 million) in an initial public offering on the Hong Kong stock market. Its shares opened at HK$12.32, jumped 12% and closed at HK$13.8 on the first trading day. Hangzhou, China-based Adicon is among the top three independent clinical laboratory (ICL) service providers in China by total revenues. It offers testing services to hospitals and health check centres through a network of 33 self-operated laboratories across China.
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.
Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions.
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Dexcom.
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