Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as well. Keisha Thomas, associate director for compliance and quality at CDRH, told an audience in Washington DC that risk management will be a big focus in FDA oversight and inspections in 2026, a point of emphasis that could lead to more routine compliance and enforcement action.

After raising more than twice as much as expected in its March IPO, Kestra Medical Technologies Inc. appears poised to repeat its success with an upsized secondary offering as well. The Kirkland, Wash.-based company initially planned to offer 5.5 million shares in its second pass at the market but increased the number of shares to 6 million two days later when it set the price at $23 per share. The projected gross proceeds of $138 million provide a nice addition to the $232 million raised nine months ago.

Sen. Bill Cassidy, R-La., who chairs the Senate Health, Education, Labor and Pensions Committee, released another letter to the American Medical Association regarding the activities of the AMA committee for CPT coding activities.

Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure.

The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.

SS Innovations International Inc. is experiencing rapid growth and rising demand for its SSi Mantra 3 surgical robotic system. Its revenues are increasing, and so are installations and procedures driven by the design features and affordability of the SSi Mantra, said Sudhir Srivastava, chairman of the board and CEO of SS Innovations. “The system that we have created is, in my personal opinion, better than anything that exists out there because of its various differentiating features and cost effectiveness,” he told BioWorld.

Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.

Prognomiq Inc. reported the launch of its Provue Lung, a novel blood-based laboratory developed test designed to help improve detection of lung cancer at its earliest, most treatable stages.