Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has imposed a 60-day delay in the implementation of the Medicare Coverage of Innovative Technologies (MCIT) program, stating that the MCIT draft rule was developed under a flawed assumption about the volume of eligible breakthrough devices. CMS said the situation suggests that the public did not have an appropriate opportunity to comment on the proposed rule, a predicament that suggests the possibility that the MCIT program might not survive the Biden administration’s regulatory review. Read More
Variantyx Inc. raised $20 million in a series C financing led by GHS Fund (Quark Venture LP and GF Securities). The new funds are earmarked for the development of comprehensive tumor diagnostic solutions and sales expansion. Also taking part in the round were new investor IBM Ventures and existing investors Pitango Venture Capital, New Era Capital Partners and 20/20 Healthcare Partners. With this latest infusion, Variantyx has raised a total of $38 million. Read More
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins. Read More
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Hemex Health, Masimo, Painteq, Strata Skin Sciences, Wellframe. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA comments on two patent term extensions; Comment period reopened on Orange Book patents. Read More
Keeping you up to date on recent developments in cardiology, including: Lack of ‘moral compass’ cited as driver of increase in atherectomy in PVI; Study links hypertension to atrial fibrillation; Machine learning of limited value in predicting in-hospital AMI death. Read More
