Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation. Read More
The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026. Read More
Two U.S. Medicare administrative contractors (MACs) have removed CPT code 6468 from their group 1 CPT codes, a move that may cut rates for implant of Inspire Medical Inc.'s flagship product, the Inspire hypoglossal nerve stimulator for treatment of obstructive sleep apnea. Read More
In 2025, science saw its breakthroughs, which BioWorld will be covering as part of our end-of-the-year wrap-up. But the biggest science story of 2025 is not about any scientific advance. It is the politicized destruction of U.S. science, and the dismantling of a scientific ecosystem that has been the envy of the world since it emerged after Germany destroyed its own pre-eminence in the 1930s. Read More
Quanterix Corp. reported the publication of a landmark study in Nature which utilized its Simoa p-Tau 217 (phosphorylated tau at threonine 217) research assay. The Nature study is the largest population-based assessment of Alzheimer’s Disease Neuropathological Changes to date, providing crucial, scalable data to redefine disease prevalence it said. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Brainsway, Ion Beam Applications, Optum, ORA, Staar Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Shape Memory Medical. Read More
