Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin.
The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort.
NHS England has announced a new £340 million (US$481 million) Innovative Medicines Fund, as the country grapples with the issue of bringing ultra-pricey specialist medicines to patients on the country’s taxpayer-funded health care system.
The U.S. Office of Science and Technology Policy and the National Science Foundation are issuing a request for information to help the National Artificial Intelligence Research Resource Task Force in developing an implementation roadmap.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Ascletis, Biovaxys, Erytech, Index, GBT, Humanigen, Merck & Co., Pfizer, Radius, Rational Vaccines, Sorrento.
The U.S. Federal Trade Commission (FTC) had previously reported it would more tightly scrutinize mergers and acquisitions with an eye toward the impact on competition, and voted July 21 to expand its authority to review these activities. The agency also voted to eliminate restrictions by original equipment manufacturers (OEMs) on servicing of their devices, thus putting both drug and device makers on alert that much more rigorous FTC enforcement has arrived.
PERTH, Australia – The FDA gave the thumbs up to Omniscient Neurotechnology Ltd.’s Quicktome, the first brain connectomics planning software that provides neurosurgeons with a digital brain mapping platform to visualize and understand a patient's brain networks before performing brain surgery. By visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anchordx, Congenica, Innovative Health Sciences, Omniscient Neurotechnology, Philips, Synapse Biomedical, Zoll Medical.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.