Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.

Boston Scientific Corp. continued its journey down the acquisition highway with its announced plan to acquire stroke products maker Silk Road Medical Inc. for $27.50 a share, or approximately $1.16 billion.

The U.S. FDA cleared Basel, Switzerland-based Roche Holding AG’s whole-slide imaging system, the Roche Digital Pathology Dx, for use as an aid in clinical diagnosis. The system helps pathologists review and interpret digital images of scanned pathology slides.

An interdisciplinary team of researchers from the University of Arkansas have filed for protection of an optical sensing platform and method for synovial fluid analysis to reduce diagnosis time leading to quicker results for doctors and patients. Their innovation allows for faster and non-destructive evaluation of biological samples.

Elutia Inc. received U.S. FDA clearance for its antibiotic-eluting bioenvelope. Designed to prevent post-operative complications from the implantation of cardiac devices such as pacemakers and defibrillators, Elupro (formerly Cangaroo RM) combines slow release of the antibiotics rifampin and minocycline with a biomatrix that stimulates regeneration of a tissue pocket to surround and protect the device.

For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.

Criticisms over the U.S. FDA’s use of advisory committees led the agency to hold a June 13 public hearing during which FDA commissioner Bob Califf said the agency is working to improve the experience of special government employees who take part in these hearings.

Even patent attorneys aren’t particularly collectively excited about standard essential patents, but that hasn’t stopped the U.S. Patent and Trademark Office from signing a memorandum of understanding with the U.K. Intellectual Property Office to collaborate on policies related to these patents.

Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.