Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures. MITA’s executive director, Patrick Hope, said the Medicare hospital outpatient program is overdue for an overhaul of its packaging policy for payments for radiopharmaceuticals and that the Medicare physician fee schedule should be insulated from further cuts for the professional component of imaging procedures, changes Hope said are necessary to ensure continued patient access to these services.
If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
In August 2023, med-tech firms raised a total of $1.88 billion through 27 transactions, an increase of 94.12% from the $971 million raised in July. Value is down 42.83%, however, from the $3.3 billion raised in August 2022. The volume of med-tech financings is tracking at an average of 41 per month in 2023, down from an average of 43 per month in 2022, 59 per month through 2021 and 60 per month in 2020.
In a potential breakthrough for diagnosis and treatment development of liver disease, the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identified four biomarkers that outperform current liquid biopsies for NASH.
Direct-to-consumer advertising (DTC) for medical devices does not present the same policy footprint as DTC ads for drugs, but Congress recently asked the U.S. Government Accountability Office (GAO) to investigate device advertising to evaluate whether reforms are needed. GAO responded to the effect that while the literature lacks any useful studies on the question, some stakeholders believe that DTC device ads give short shrift to risk information, a finding that may prompt Congress to enact new legislation on the question.
Amsterdam-based Royal Philips NV reported that it has come to terms with customers and end users of its respiratory equipment to the tune of $479 million, which will reimburse for the cost of these systems. The problem for the company is that the settlement does not affect any personal injury cases, and thus represents only a partial closure of a controversy that has dogged the company for several years.
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
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