Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).
South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Chemomouthpiece, Seastar, Spectral AI, Venus Concept, Zimmer Biomet.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Establishment Labs, Mainz Biomed, Naveris, Solventum.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Evoq, Inoviq.
After nearly a decade and a half of service at the U.S. FDA, Bill Maisel will retire from the agency, taking with him a wealth of experience as both a physician and a regulator. The agency said Owen Faris, also a long-time member of the FDA staff, will take Maisel’s place as the director of the Office of Product Evaluation and Quality (OPEQ), but this is a temporary stint for Faris as the agency will conduct a search for Maisel’s replacement.
The €173 million (US$187 million) in capital that Earlybird Health recently raked in from investors will go towards bolstering investment in European health care startups, many of which are still recovering from the impact of COVID-19, Thom Rasche, a partner at Earlybird Health, told BioWorld. The fund is looking to invest in the technologies that can improve patient care.
Reprieve Cardiovascular Inc. landed $42 million in its first fundraising round out of stealth to fund development of its acute decompensated heart failure treatment. The series A round will support clinical and development programs, including the ongoing FASTR trial and Reprieve’s upcoming pivotal trial.
RSS
