Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks. Read More

Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia. Read More

The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is flexible on the proposed one-year implementation deadline. However, Shuren also noted that the draft rule would not be converted into a final rule at any point during the current calendar year, leaving device makers with an extended term of uncertainty. Read More

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. Read More

A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration. Read More

New hires and promotions in the med-tech industry, including: Avacen Medical, Cadence, Epicore Biosystems, Seaspine, Wenzel Spine. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Big Health. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bartec, Cardiawave, Clearpoint, Higgs Boson Health, Lucid, Mediso, Mico, Myriad Genetics, Nanovibronix, Neuropace, Pavmed, Reflexion Medical, Renovacare, Sectra, Soroka, Stemcell Systems, Trinity Biotech, Veeva. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cathvision. Read More