Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly. Read More
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end. Read More
Henley Ion LLC has released data showing its filter-less respirator device can remove more than 99% of SARS-CoV-2 bioaerosols. The mask prototype developed by physician and surgeon Julian Henley, uses micronized electrostatic precipitation (mEP) to remove infectious aerosol particles from both inhaled and exhaled air. Results from the study have been published in the Viruses journal and confirm the device can provide equivalent protection from infectious bioaerosols as N95 respirators. Read More
Rennes University Hospital in France has just this April completed a surgical procedure in the operating room wirelessly, thanks to the 5G network. Cardiologist Erwan Donal performed a heart operation there on a simulation manikin, monitored remotely from Athens, Greece, by heart surgeon Alexandros Stefanidis, from the department of cardiology at the General Hospital of Nikea. Read More
Apollo Global Management Inc. is taking a minority equity interest in European venture capital firm Sofinnova Partners, pledging to commit of up to €1 billion (US$1.04 billion) in managed capital to the latter’s investment coffers. Read More
Regulatory harmonization is seen as vital to the development of markets for artificial intelligence (AI) and machine learning (ML), but there is some variation in the terminology used to describe these algorithms. The International Medical Device Regulators Forum (IMDRF) has posted a document that includes some definitions for ML terms such as unsupervised machine learning, a key development if regulations across the globe are to avoid a hopeless state of balkanization. Read More
