What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
Outset Medical Inc. dropped 38% during intraday trading to reach its lowest point since going public in mid-2020 following its announcement that it began holding shipments of its Tablo hemodialysis system for home use in late May pending U.S. FDA clearance of a 510(k) submission for changes made to the device since its original clearance in March 2020. The stock which closed June 13 at $20.43, recovered some ground to close June 15 at $14.58, which is still 78% off the stock’s high in November 2020.
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
Bright Uro Inc. has emerged from stealth mode with $4 million in seed financing from Academy Investor Network, Fred Moll and several other angel investors. The company also secured a $2 million phase II small business innovation research (SBIR) grant from the NIH.
The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix.
The U.S. FDA has posted notice of an advisory issued by Dublin-based Medtronic plc, regarding the Heartware ventricular assist device due to a pump weld defect, which the agency has identified as a class I recall. The recall affects devices that have been in use since 2006 and is associated with the entry of moisture into the pump center post, which can de-magnetize the magnets and thus trigger malrotation and consequently damage to the welds.
The U.S. FDA’s device center continues to promote alternatives to ethylene oxide (EtO) as a medical device sterilant, with the latest development involving radiation as a sterilizing technology. The agency said it may open a new master file program for radiation that follows an existing program that is agnostic as to sterilization method, and which may speed the adoption of alternative sterilization methods in the years ahead. The FDA’s Center for Devices and Radiological Health recently announced a pilot program for alternatives to EtO sterilization that would eliminate a significant number of regulatory filings.
Several companies showed promising results for automated insulin delivery (AID) systems at the American Diabetes Association (ADA) annual meeting in New Orleans. Studies of the systems, also known as artificial pancreas systems, indicate that integration with continuous glucose monitoring (CGM) systems enables substantially improved glycemic control, with more time in range (TIR) and less hypoglycemia than seen with multiple daily injection (MDI) therapy or insulin-pump therapy.
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