Balt Extrusion SAS has received CE mark approval for its Silk Vista flow diverting stent for those with unruptured intracranial aneurysms. Flow diverters aim to divert blood flow away from an aneurysm, allowing it to heal and reducing the risk of rupture. Read More
Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients. Read More
The use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making may seem more aspirational than practical at times, but that state of affairs is changing rapidly. Wendy Rubenstein, director of personalized medicine at the U.S. FDA’s Center for Devices and Radiological Health, said contemporary versions of these real-world sources of evidence “are of progressively higher quality” in recent years, and thus RWE and RWD may soon hit their strides as mature sources of data with which regulators are increasingly comfortable. Read More
A first-of-its-kind clinical trial conducted by digital health startup AppliedVR suggests the computer-based technology is both feasible and effective for treating chronic pain in a patient’s own home. Read More
HONG KONG – Hong Kong’s emerging med-tech sector is getting a boost from a government-funded program aimed at sharing technology with other jurisdictions, a program driven in part by the need to contain the COVID-19 pandemic and continue opening regional economies. Read More
Med-tech firms raising money in public or private financings, including: Blackstone Group, Kernel, Medtronic, Otonexus Medical Technologies, Rokit Healthcare. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Accelmed Partners II, Alivecor, Applied DNA Sciences, Army Distaff Foundation, Boxview, Ekso Bionics, Henry Schein, Immunicom, Integragen, Lawrence J. Ellison Institute for Transformative Medicine, Lgc, Medpod, Myomo, Native Antigen, Neurometrix, Omron Medical, OncoDNA, Oracle, Osi Systems, Sectra, Sheba Medical Center, Spacelabs Healthcare, Stewart Industries, Tearlab, Visualdx, Yabao Pharmaceuticals. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter International, Diazyme, Infervision, Therapixel. Read More
Keeping you up to date on recent developments in diagnostics, including: Diagnosing fatty liver disease; Assessing COVID-19 with lung ultrasound; Noncoding mutations contribute to heart disease. Read More
