In an expansion that will surely have other companies wondering why they didn’t move on the opportunity first, Icad Inc. partnered with Solis Mammography to identify cardiovascular risk based on incidental information commonly found in mammograms—and generally ignored. Read More
Two Medicare administrative contractors are examining a request for expanded Medicare coverage of continuous glucose monitors (CGMs) that would drop the requirement that patients routinely administer insulin at least three times a day. The requestors, Alameda, Calif.-based Abbott Diabetes Care Inc., and a group of stakeholders including the Juvenile Diabetes Research Foundation (JDRF), assert that such a change is not only endorsed by two medical societies, but is also supported by clinical evidence, and the net effect for industry may be to significantly accelerate sales of these devices. Read More
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices. Read More
Jenscare Scientific Co. Ltd. has raised HK$225 million (US$29 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares opened at HK$28 per share, increased by over 9% in the middle of the day and closed at HK$28.25 on the first trading day of Oct. 10. Read More
The question of Medicare coverage for breakthrough devices is still in play at CMS, but managers there penned an Oct. 12 editorial that suggests that existing coverage mechanisms may have to suffice. CMS’s Lee Fleisher and Jonathan Blum said in the JAMA Internal Medicine (JAMA: IM) editorial that the agency might respond to the breakthrough device coverage question by applying the coverage with evidence development (CED) mechanism for breakthrough devices, suggesting that the policy might ultimately resemble the coverage mechanisms already available to industry. Read More
While third quarter med-tech financing proceeds rose by nearly 20% over the second quarter, making it the best quarter this year, amounts raised for the first nine months of 2022 are still down by 40% in comparison with 2021. Read More
New hires and promotions in the med-tech industry, including: Ancora Heart, Koru Medical Systems, Miach Orthopaedics, Owens & Minor, Torus Biosystems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Healthcare, Mayo Clinic, Nucleus Radiopharma, Panaxium, Radiation Business Solutions, Sectra AB, Siemens Healthineers, Synaptive. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Etiometry, Neurologica, Osteocentric Technologies, Xact Robotics. Read More
