Accyourate Group S.p.A has stepped up the commercialization of its e-shirt, a 100% textile smart T-shirt which enables continuous real-time monitoring of biomedical and vital body signals. Accyourate joins a host of companies releasing products in the wearable device market as different technologies for health care including heart rate monitoring, fitness, breathing, temperature levels and fall detection get more sophisticated and grow in popularity. Read More
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products. Read More
The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report. Read More
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices. Read More
The U.S. FDA has issued a guidance on when to file a new 510(k) for a class II device that has undergone significant modification, but that doesn’t mean everyone in the device business is paying attention. The FDA hit Synovo Production Inc., of Fullerton, Calif., for a number of violations of the Quality System Regulation (QSR), but also alleged that the manufacturer/specification developer made a number of modifications to its femoral resurfacing cup for hip implants without a new regulatory filing, leading the agency to direct the company to immediately cease production of the device. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acuitymd, Caredx, Celanese, Dilon Technologies, Glaukos, Grail, Miromatrix Medical, Penumbra, Ur24 Technology. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abyrx, Synapse Biomedical, Zap Surgical. Read More
