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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter International, Diazyme, Infervision, Therapixel.
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.
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.
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
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