Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.
The Alzheimer’s Drug Discovery Foundation (ADFF)’s Diagnostic Accelerator launched the first longitudinal, international study of vocal changes associated with Alzheimer’s disease (AD). Part of a $100 million effort to develop affordable biomarkers for AD, the study hopes to create the world’s largest database of speech and vocal data to facilitate diagnosis and monitoring of neurodegenerative disease.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
Royal Philips NV received a second round of funding from the Bill & Melinda Gates Foundation to speed adoption of artificial intelligence (AI) algorithms on the Lumify hand-held ultrasound device, bringing its total commitment to the project designed to reduce maternal mortality to $60 million.
Abbott Laboratories received U.S. FDA approval for its molecular human papillomavirus (HPV) screening test, expanding the company’s cancer screening tools. The new member of the Alinity M family of diagnostic assays can be used for screening, as recommended by current guidelines, as well as diagnosis and provide detailed information on the potentially cancer-causing genotypes of the virus.
Illumina Inc. launched the next generation of its distributed liquid biopsy assay for genomic profiling. The updated Trusight Oncology (TSO) ctDNA v2, currently available for research use only, allows comprehensive genomic profiling (CGP) of circulating tumor DNA with only a blood sample.
Just weeks after securing U.S. FDA approval for its flagship system to treat chronic limb-threatening ischemia (CLTI), Limflow SA kept the good news flowing to investors with the announcement of an agreement to be acquired by Inari Medical Inc. in a deal valued at up to $415 million. Inari will pay $250 million in cash at closing with up to $165 million in additional payments going to Limflow based on achievement of specified commercial and reimbursement milestones starting in 2025. The companies expect the deal to close by the end of the year.
Access Vascular Inc. (AVI) closed a $22 million series C funding round that it plans to use principally to increase production capacity for its Mimix hydrophilic biomaterial vascular access devices. The company’s catheters are designed to evade identification as foreign bodies, reduce bacterial adhesion and eliminate catheter-related thrombus development.
There’s nothing scary for Ametek Inc. shareholders in the $1.9 billion acquisition of Paragon Medical Inc. announced on Oct. 31, 2023. The deal moves the industrial technology company solidly into the med-tech space as it picks up Paragon’s portfolio of products in orthopedics, minimally invasive surgery, robotic surgery and drug delivery, and adds an estimated $500 million per year in revenue and “very strong EPS accretion,” Ametek CEO David Zapico said in an investor call on Oct. 31.
