In what one analyst labeled as a “summer surprise,” Varian Medical Systems Inc. and Siemens Healthineers AG said they plan to combine in an all-cash transaction valued at $16.4 billion. Varian’s board has backed the agreement, which will see Siemens Healthineers pick up all outstanding shares for $177.50 per share in cash, representing a premium of about 42% to the 30-day volume weighted average closing price of Varian's common stock as of July 31. The transaction is expected to close in the first half of calendar year 2021. Read More
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences. Read More
The U.S. FDA expanded the indications for Stryker Corp.’s Neuroform Atlas stent system to include use in the posterior circulation or back of the brain, making the device the only adjunctive stent approved for aneurysms in this challenging location. The Kalamazoo, Mich.-based company’s intracranial coil-assist stent gained its initial indication for the more common aneurysms in the anterior circulation of the neurovasculature in May 2019. Read More
A number of entities have sounded off on the FDA’s discussion paper for artificial intelligence (AI), including several medical societies that would like to see autonomously operating algorithms subjected to more stringent review than supervised algorithms. Vibhor Rastogi, general partner at Symphony AI of Los Altos, Calif., told BioWorld that the company is on board with many of these concerns, adding that the FDA discussion paper does a “good job of balancing innovation and patient safety.” Read More
TORONTO – Dishing out hundreds of millions of dollars for new COVID-19 fighting ventilators, test kits and antibody detection platforms Ottawa has another vital gap to close: the time it takes to approve these technologies for the marketplace. A new Canadian pilot program could significantly reduce the amount of time it takes to determine if these technologies are ready for prime time. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American College of Radiology, Asuragen, Bio-Techne, Brain Scientific, China Grand Pharmaceutical and Healthcare, Clinical Reference Laboratory, Co-Diagnostics, Iotron Industries, Kantaro Biosciences, Karius, Medicrea, Mount Sinai Health System, Pacific Biosciences, Personalis, Quest Diagnostics, Renalytix AI, Sirtex Medical, Sotera Health, Sterigenics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Stryker. Read More
Keeping you up to date on recent developments in cardiology, including: Genetic variants contribute to heightened death risk from stroke in those of African descent; Pathologists publish report on likely MIS involving the heart; Studying COVID-19’s impact on the heart. Read More
