May Health SAS closed a $25 million series B financing round to advance its Ovarian Rebalancing therapy for polycystic ovary syndrome (PCOS)-related infertility. The round brings the total funds raised by the Paris-based company to date to $35 million, May Health CEO Anne Morrisey told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro, Oxehealth, Qiagen, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corepath, GTC, IDT, Molecular Health, Neuronetics, Rapid Medical, Sevaro.
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
Brixton Biosciences Inc. closed a $33 million series B funding round that it plans to immediately use to pursue two clinical trials to evaluate the use of its Neural Ice nerve block for knee pain. The injectable product received U.S. FDA breakthrough device designation in October.