Boston Scientific Corp. agreed to acquire the Baylis Medical Company Inc.’s cardiology business, Baylis Medical Co., for an upfront payment of $1.75 billion, subject to closing adjustments. The transaction is expected to close in the first quarter of 2022. Baylis Medical Technologies, which focuses on radiology and neurosurgery, is not part of the deal and will remain a separate entity. Read More
Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra. Read More
The America Invents Act (AIA) is barely 10 years old, but a bipartisan pair of U.S. senators have proposed patent reform legislation that would amplify the use of the inter partes review (IPR) process to challenge an existing patent. There are several critical features of the new legislation, but Sens. Patrick Leahy (D-Vt.) and John Cornyn (R-Texas) said the legislation would relieve the problem of poor-quality drug patents that “drive up the costs of prescription drugs.” Read More
TORONTO – Numalogics Inc. has entered a partnership deal with Sawbones Inc. to develop computational modeling and simulation software for small and medium sized orthopedic manufacturers. Adding Montreal-based Numalogics’ computational simulation software to Seattle-based Sawbones’ biomechanical test line is intended to help customers optimize their orthopedic device designs more quickly and efficiently. The software is expected to be market ready in 2022. Read More
The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution. Read More
New hires and promotions in the med-tech industry, including: Caris Lifesciences, Dermtech, Microport Orthopedics, Potrero Medical, Rapid Micro Biosystems, Rebus Biosystems, Recoveryone, Roswell Biotechnologies, Waters. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Diadem, Guardant Health, Know Labs, Natera, Philips. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aetion, Arterys, Bone Health Technologies, Cognetivity Neurosciences, Cue Health, Google, Lighthouse Imaging, Nanodx, Onemednet, Precision Optics, Sectra, Sengine Precision Medicine, Skywater Technology, Sword Health, Unilabs, Vigilant Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, GE Healthcare, Syncthink. Read More
