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. Read More
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. Read More
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version.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. Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asieris, Biodesix, Corevitas, Edp Biotech, Electrocore, Intelligent Bio, Myriad, New Day Diagnostics, Proov, Quest Diagnostics, Resmed, Somnoware, T2 Biosystems, Tempus Labs, Thermo Fisher, Tscan Therapeutics, Tscom. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bellaseno, Biotronik, Genesis Medtech, Inovedis, Livsmed, Medrhythms. Read More
