Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.
Advanced manufacturing company Linamar Corp. has created Linamar Medtech to leverage its skills in precision manufacturing in the medical device and components space. The new venture, which will operate as a separate division under the Linamar umbrella, builds on recent programs producing a range of products, including ventilator systems and parts, part of the COVID-19 pandemic response.
Pleno Inc. has secured $15 million in a pre-series A financing led by Medical Excellence Capital and Alexandria Venture Investments. The proceeds will support development of startup Pleno’s Hypercoding multiomic instrument platform. In conjunction with the financing, Pleno named Gregory Lucier as chairman of its board of directors.
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
Beacon Biosignals Inc. has teamed up with Stratus Inc., a provider of electroencephalogram (EEG) services, to improve at-home brain monitoring and neurodiagnostics using Beacon’s machine learning-driven neuroanalytics platform. The collaboration will increase opportunities for home-based studies of Alzheimer’s and other neurological diseases.
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
Biofourmis Inc. secured $300 million in a series D financing led by General Atlantic, with participation by CVS Health and existing investors. The round lifted the Boston-based company’s valuation to more than $1 billion and unicorn status, according to executives. Biofourmis will use the funds to drive next-stage growth in its virtual care offerings and digital therapeutics (DTx).
