Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021. Read More
The Biden administration has released a blueprint for an artificial intelligence bill of rights, which is accompanied by an acknowledgement that these algorithms can be crucial in guiding treatment of cancer patients. Read More
The U.S. FBI is not typically seen as playing a meaningful role in medical device cybersecurity, but the agency recently released a report regarding unpatched and outdated medical devices, nonetheless. The report includes five recommendations to deal with these devices, but the agency gives no indication as to whether the report signals an interest in enforcement activities related to medical device cybersecurity. Read More
A new prototype device that delivers barely perceptible vibrations to the fingertips has led to improvements of between 20% – 40% in patients who have lost their sense of touch following an ischemic stroke. Read More
Anvisa, Brazil´s health care surveillance agency, issued new regulations for the registration of medical devices as it works to harmonize its own rules with international standards and integrate its medtech industry with those of other countries in the region. Read More
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alimentiv, Apollolims, Clinisys, Common Cents, Endomag, Horizon Lab, Interflex, Nevro, PPD, Sema4, Satisfai, Simon Hegele Healthcare Solutions, Sunquest, Thermo Fisher, Virgo Surgical, Xosomix. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine. Read More
