Nanox Imaging Ltd. agreed to acquire Zebra Medical Vision Ltd. for up to $200 million and signed a letter of intent to buy Usarad and its related company Medical Diagnostics Web for $30 million. Timing of the transactions, designed to create an end-to-end radiology solution, was not disclosed.
Spintech’s MRI enhancement technology gets FDA nod
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 clinicians to capture higher-quality brain images in significantly less time than standard approaches.
Appeals court affirms Life Spine’s injunction against L&K Biomed for Prolift device
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 the Defend Trade Secrets Act of 2016 can be useful in taking trade secret disputes directly to federal court, thus bypassing the more cumbersome state court route and offering rapid injunctive relief that may prove critical to sustaining a device’s market value.
Graphene coating may prevent the formation of biofilms on medical implants
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. As the world’s thinnest, strongest and most conductive material, biomedical applications of graphene ranging from wound-monitoring plasters, to replacement retinas, implants for deep brain stimulation and toxicology sensors, are in development.
FDA: Imaging agents to transition from drugs to devices
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is conceding on how it regulates imaging agents. That means the agency will transition 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. The FDA said in the past it believed it had the discretion to approve imaging agents as drugs even when they met the device definition. The appellate court disagreed.
HHS settles whistleblower complaint with former BARDA director
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. According to his complaint, Bright was reassigned to a nonsupervisory position at the NIH after he raised concerns about the government's COVID-19 response and about influence exerted by political and industrial interests on BARDA and HHS, both before and during the pandemic.
Boston Scientific recalls Ingenio devices due to faulty transition to safety mode
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.
Also in the news
Abbott Laboratories, AMDL, Aurora Spine, Cardinal Health, Electrocore, Empiramed, Fitbit, Fujifilm Irvine Scientific, Inspira, Konica Minolta, Lifescan, Oncxerna, Presagen, Pyramid Innovation, Qiagen, Quidel, Statlab Medical Products