The U.S. FDA’s guidance for electromagnetic compatibility (EMC) in medical devices has several moving parts, a consequence of the fact that the scope included cardiac electrophysiology devices and non-implantable medical devices. For the most part, the terms of the guidance will go into force within 60 days, but the compliance deadline for in vitro diagnostics (IVDs) doesn’t go into force until June 6, 2023, giving these manufacturers much more breathing room than their non-IVD counterparts.
The U.S. FDA determined that the pandemic required an adjustment to applicant turn-around times for the agency’s responses to regulatory filings, an allowance that was unavoidable given the impact of the pandemic on applicants’ ability to respond. That policy has now been reversed, the agency said, which means that a failure to respond to queries about 510(k) filings within 180 days will lead to an assumption on the agency’s part that the applicant has withdrawn the submission.
Wandercraft SAS unveiled Atalante X, its next-generation autonomous exoskeleton based on the concept of dynamic robotics. This self-balancing, walking exoskeleton, hands-free and without crutches, helps patients at all stages of physical therapy for learning to walk again by replicating a natural walking pattern. “We are responding to a major demand for physical therapy for learning to walk again while relieving the work of clinical staff,” Matthieu Masselin, CEO and co-founder of Wandercraft, told BioWorld.
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.
Numerous life sciences firms are targeting digital health and diagnostic companies for take-outs and licensing deals, placing the med-tech industry in a strong position in 2022.
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