As more big and small device makers are entering the digital health sector, AdvaMed Digital hopes "to identify slightly more futuristic technologies that might not have a way to come to market in the current environment" because regulation of products in this sector is unclear, said Zach Rothstein, vice president for technology and regulatory affairs at AdvaMed. AdvaMed Digital is focusing on companies of various sizes and descriptions for membership and hopes to significantly increase its member base by year end.
Becton Dickinson has agreed to pay $24 billion for C.R. Bard, a maker of catheters and implantable heart devices, in a cash-and-stock deal that represents a 25.2% premium over Bard's April 21 closing price and that is expected to be completed this fall. BD is creating a new unit, BD Interventional, into which it intends to integrate Bard's businesses, and the unit will be overseen by newly promoted BD President Tom Polen.
Abbott CEO Miles White said the company's acquisition of Alere will progress as planned and be completed by the end of the third quarter. The company, which still needs to divest some of its businesses to close the transaction, believes the purchase would be a net gain and would enable expansion of Abbott's diagnostics business in the point-of-care space, White said.
Malosa Medical, a UK-based maker of single-use ophthalmology surgical instruments, has been acquired by Waltham, Mass.-based Beaver-Visitec for undisclosed terms. Malosa's portfolio includes over 400 products.
A round of funding has brought in $4.5 million for Kirkland, Wash.-based Cardiac Insight, which is developing advanced body-worn sensing and computing technologies for the diagnosis of respiratory and cardiology diseases. The proceeds will be used for continued development and commercialization of the company's Cardea SOLO device.
Exclusive sales representative deals have been reached by Canada-based 7D Surgical with DB Surgical and Surgical One to boost the sales presence of its machine-vision image guided surgery platform, the 7D Surgical System, in the US. DB Surgical will be in charge of sales in the Southeast, while Surgical One will be responsible for the Midwest to the Gulf Coast.
A patient at Nicklaus Children's Hospital in Miami was the first to undergo focused ultrasound procedure using Insightec's Exablate Neuro system. The procedure was part of a feasibility study that seeks to assess the device as an incisionless ablative treatment for benign centrally located intracranial tumors in young adults and pediatric patients.
The Department of Defense's Defense Logistics Agency has awarded Stimwave Technologies a five-year Distribution and Pricing Agreement to provide the agency with its Freedom spinal cord stimulation systems. The product comes as a wireless, fully programmable neuromodulation device designed for treating chronic, intractable back or leg pain.
Comments have been submitted by stakeholders about the FDA's draft guidance on communications between manufacturers and payers concerning unapproved medical products, with AdvaMed suggesting that the agency should identify the differences between communications for medtech and pharmaceutical companies. The guidance should also recognize communications with "value committees," "buyer committees" and "stakeholder coding committees" to improve clarity and better incorporate the views of those who review medtech for coverage and reimbursement decisions, AdvaMed said.
HitGen will collaborate with The Scripps Research Institute and its California Institute for Biomedical Research unit to discover and develop drug candidates for oncology, regenerative medicine and other therapeutic areas. The collaboration will identify small molecule leads against multiple targets using HitGen's DNA-encoded libraries, which include more than 25 billion compounds.