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 U.S. FDA-cleared, Apyx offers incision-free pelvic organ prolapse treatment to the women suffering from the often painful and debilitating condition.

Renalytix receives de novo authorization

The U.S. FDA granted Renalytix de novo marketing authorization for its Kidneyintelx.dkd 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.

Stakeholders seek clarity on intended use, combo products in US FDA’s change control draft 

The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version.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 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 nets $52M in Hong Kong IPO, shares jump 12% on debut

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 service providers in China by total revenues. It offers testing services to hospitals and health check centers through a network of 33 self-operated laboratories across China. The company will use 15% of the proceeds from the IPO to improve its routine and esoteric testing capabilities. It plans to expand and strengthen its R&D capabilities in obstetrics and gynecology, solid tumor, hematology, and infectious disease. It will also purchase esoteric technologies in next-generation sequencing testing modalities, mass spectrometry and flow cytometry.

$2M to boost advance of a device for detecting early signs of UTI

A successful $2 million early stage funding round will support the development and launch of a medical device designed by Astek Diagnostics Inc. to speed recovery for patients suffering from urinary tract infections. The Jiddu features a benchtop analyzer and disposable cartridge key to testing urine samples for infection and determining the correct antibiotic to be used to treat the disease.

Also in the news

Append Medical, Asieris, Bellaseno, Biodesix, Biotronik, Edmund Optics, EDP Biotech, Electrocore, Genesis Medtech, Inovedis, Intelligent Bio Solutions, Medhub-AI, Medrhythms, Moleculight, Myriad Genetics, New Day Diagnostics, Proov, Quest, Resmed, Somnoware, Strata Skin Sciences, T2 Biosystems, Tempus, Thermo Fisher Scientific