The company pleaded guilty to a misdemeanor misbranding charge and agreed to pay $11m in criminal penalties and another $25m to resolve civil False Claims Act allegations. Biocompatibles reportedly marketed its LC Bead product as a drug-delivery product, even though it was cleared only for embolization.
Biocompatibles Inc.'s recent $36m settlement with the federal government stemmed from allegations that the BTG Plc. subsidiary sold its LC Bead device as a combination product without proper approval, according to US Department of Justice. The arrangement included a guilty plea to a misdemeanor misbranding charge.
LC Bead is used to treat liver cancer, among other conditions. US FDA cleared it as an embolization device that could be placed in blood vessels to block or reduce...
Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
