While the 441 med-tech financings completed so far this year are nearly as much as this point last year (446), the amount of money raised, at $33.43 billion, is 17% below the amount raised through early August of 2020 ($40.14 billion). Just two months ago, the volume of financings was 10% higher than last year, indicating a recent slowdown in activity. Nevertheless, 2021 appears to be on track to beat the $40.7 billion raised in 2019, and it is already ahead of the full year amounts for 2017 and 2018.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
LONDON – Swedish researchers have devised a method for binding insoluble antibiotics to graphene coatings, in an advance that could prevent the formation of biofilms on medical implants. In comparison to other long-winded methods for loading antibiotics onto implant surfaces, they say the way in which they bind active molecules to graphene is simple and could easily be integrated into manufacturing processes.
The U.S. Court of Appeals for the Seventh Circuit has affirmed an injunction obtained by Life Spine Inc. against L&K Biomed for the latter’s alleged appropriation of trade secrets obtained by an L&K subsidiary. The outcome affirms that injunctive relief is available to plaintiffs when irreparable harm is plausibly alleged, but also highlights the need for internal controls to avoid accidental use of trade secrets during product development programs.
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
Continuing its push to streamline the imaging industry from equipment to vertical integration, Nano-x Imaging Ltd. (Nanox) agreed to acquire Zebra Medical Vision Ltd. and signed a letter of intent to buy Usarad Holding Inc. and its related company Medical Diagnostics Web. The timing of the transactions, designed to create an end-to-end radiology solution, was not announced.
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise.
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.
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