Gradient Denervation Technologies SAS closed a €14 million (US$15 million) series A financing round that will help the company with the ongoing clinical development and evaluation of its ultrasound-based catheter device to treat pulmonary hypertension. The financing round was led by Asabys Partners, with participation from Thuja Capital and founding investor Sofinnova Partners.

US GAO says data on medical device advertising lacking, but stakeholders wary of ads

Direct-to-consumer advertising (DTC) for medical devices does not present the same policy footprint as DTC ads for drugs, but Congress recently asked the Government Accountability Office (GAO) to investigate device advertising to evaluate whether reforms are needed. GAO responded to the effect that while the literature lacks any useful studies on the question, some stakeholders believe that DTC device ads give short shrift to risk information, a finding that may prompt Congress to enact new legislation on the question.

Two med-tech IPOs in August bring 2023 total to five

In August 2023, med-tech firms raised a total of $1.88 billion through 27 transactions, an increase of 94.12% from the $971 million raised in July. Value is down 42.83%, however, from the $3.3 billion raised in August 2022. The volume of med-tech financings is tracking at an average of 41 per month in 2023, down from an average of 43 per month in 2022, 59 per month through 2021 and 60 per month in 2020.

NIMBLE blood test streamlines NASH diagnosis

The Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identifies four biomarkers that outperform current liquid biopsies for NASH and could provide a reliable alternative to the current gold standard of liver biopsy.

Japan’s PMDA sees a role for e-consent in clinical trials

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent. However, PMDA advised that populations that are unfamiliar with modern electronic technology may need some coaching up on the technologies that would be used for e-consent, a predicament that might be more readily resolved with traditional, person-to-person consent for this subset of potential study participants.

Also in the news:

Aesthetic Medical, Alcon, Castle Biosciences, Dermtech, Genedx, Limaca Medical, Lunit AI, Nemaura Medical, Novocure, Onpoint Surgical, Owkin, Precise Bio, Senseonics Holdings, Sirtex Medical, Thirona, Tissuecypher, Tribun Health