Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round. Read More
The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD). Read More
The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices granted market access under the legacy system. MDCG has clarified that these devices will be subject to postmarket surveillance requirements under the MDR system rather than the previous system, although it is not a simple process to determine when this approach does and does not apply. Read More
PERTH, Australia – Medical device stakeholders generally opposed the Therapeutic Goods Administration’s (TGA) proposal to refine regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. The agency received 45 comments, 17 of which came from medical device manufacturers or associations representing device manufacturers or sponsors, and most of those comments did not support the proposal to refine the regulations. Read More
Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld. Read More
New hires and promotions in the med-tech industry, including: Aerami Therapeutics, Coopercompanies, Embr Labs, Emed, Insightful Science, Lynx Biosciences, Neux Technologies, Physiq. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocept, Biodesix, Helio Health, Fulgent Genetics, Proteomedix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biointellisense, Burning Rock, Caredx, Diabeloop, Exact Sciences, HTG Molecular, Inflammatix, Labcorp, Linus Biotechnology, Makromed, Medtrials, Mednet, Medx, Merck, Rockley Photonics, Terumo. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lunit, Neurent Medical, Strados Labs. Read More
