A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
A late-breaking study presented at the PERT Consortium 2025 Pulmonary Embolism Scientific Symposium in San Diego showed marked clot-burden reduction with no device-related serious adverse events for Imperative Care Inc.’s Symphony thrombectomy system, though other companies have a head start. Circulation: Cardiovascular Interventions simultaneously published the study in an article titled “A Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.”
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
After a five-year partnership, Senseonics Holdings Inc. and Ascensia Diabetes Care Holdings AG, a unit of Tokyo-based PHC Holdings Corp., agreed to transition worldwide commercialization and distribution of Senseonics’ Eversense 365 implantable continuous glucose monitor back to Senseonics beginning on Jan. 1, 2026.
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
On the heels of the announcement of German bionics developer Ottobock SE KGaA's pending IPO and more than 20 med-tech IPOs completed to date in 2025, four other med-tech companies spanning three continents queued up to go public on four exchanges, potentially signaling an active fall for med techs worldwide.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
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