Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients.
Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release.
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A handful of medical organizations released guidelines today on the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic.
The guidance released today by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA) builds on the April 17 joint statement by AHA, AORN, the American College of Surgeons, and the American Society of Anesthesiologists on the resumption of elective surgeries.
Several medical device companies, especially those in orthopedics, have suffered major drops in sales since the Centers for Medicare and Medicaid Services (CMS) recommended in March that healthcare providers postpone elective procedures until further notice to preserve personal protective equipment. The CMS decision followed one by the American College of Surgeons calling for hospitals to “minimize, postpone or cancel” elective procedures until the coronavirus (COVID-19) outbreak s…
Zebra Medical Vision announced today that it received its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product.
The Kibbutz Shefayim, Israel-based company’s latest artificial intelligence-based product automatically identifies findings suggestive of compression fractures, which enables clinicians to place patients that are at risk of osteoporosis in treatment pathways that can prevent potentially life-changing fractures.
VCF expands Zebra’s AI1 bundle of FDA-cleared AI products, which now has a fourth U.S. patent in its bone health series, according to a news release. Zebra touts itself as the first AI startup in medical imaging to receive FDA clearance for a population health solution.
“Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are under detected globally,” Zebra CEO Ohad Arazi said in the news release. “Th…
N95 respirator [Image from the FDA]
3M (NYSE:MMM) has settled one of several price-gouging lawsuits it filed recently over its N95 respirators, according to a report by Law360.The lawsuit, filed April 30 in federal court in Tallahassee, Fla., had accused Atlanta, Ga.-based 1 Ignite Capital LLC, Institutional Financial Sales LLC, and Auta Lopes of attempting to sell 10 million N95 respirators to the Florida Division of Emergency Management at nearly 460% over list prices, and for falsely claiming that they were working with 3M.
In a filing on Friday, Maplewood, Minn.-based 3M said it had reached a settlement with the company to end the lawsuit, Law360 reported. Terms were not disclosed.
The company filed a total of 10 such lawsuits in April and said it will donate any damages recovered to COVID-19-related nonprofit organizations.
3M did not immediately respond to a request for comment on Fri…
(Image from Unsplash)
The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing.
Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for COVID-19 testing.
The FDA also authorized two COVID-19 diagnostic tests (under two separate EUAs) for use with samples collected using the Everlywell COVID-19 home collection kit. The administration is open to authorizing additional tests should data be submitted that demonstrates the accuracy of the test when used with Everlywell’s kit.
Using the Everlywell kit that contains nasal swabs, a sample is collected from inside the patient’s nose and used with a tube filled with saline to tran…
Balt announced that it received FDA investigation device exemption (IDE) for its trial for the treatment of chronic sub-dural hematoma.
The Squid trial for the embolization of the middle meningeal artery (STEM) is a prospective, randomized controlled trial for Balt’s Squid liquid embolic device as a minimally invasive treatment option for the neurological disease.
Irvine, Calif.-based Balt will investigate the safety and effectiveness of middle meningeal artery (MMA) embolization with the Squid device for managing CSDH in both surgical and non-surgical patients.
Co-primary investigator Dr. Adam Arthur of the Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center said in a news release that the study will help to understand how to treat a major reversible cause of dementia and disability in the elderly.
“The approval of the IDE for the STEM trial represents a significant milestone for Balt as this wil…
Abbott’s ID Now test machine (Image from Abbott)
After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.
Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”
A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.
One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…
The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.
One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.
Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre…
Olympic Ophthalmics announced today that it received FDA de novo clearance for its iTEAR100 neurostimulation technology for acute tear production.
The Issaquah, Wash.-based company’s prescription iTEAR100 system stimulates a cutaneous nerve to temporarily increase acute tear production in adults.
Olympic Ophthalmics’ neurostimulator is a stand-alone, pocket-size device that requires a 30-second-or-less application to the skin of the external nasal region. The application stimulates the trigeminal nerve to activate the parasympathetic nerve pathway that controls tear film homeostasis.
The company touted the system’s effectiveness in clinical trials and noted in a news release that the most common adverse effect observed was headache and dizziness, which occurred in 2%-3% of subjects.
“Olympic Ophthalmics is a team of entrepreneurs, clinicians, and investors with deep expertise in ophthalmology, neuromodulation, and medical d…
Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.
The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.
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(Image from Gilead Sciences)
Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.
The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.
The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.
Remdesivir is an intravenous drug that…
The FDA announced yesterday that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall.
The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the U.S., having been manufactured between July 23, 2015, and Nov. 8, 2018, and distributed between Aug. 25, 2015, and March 1, 2019. The company initiated the recall on Oct. 24, 2019, according to an FDA release.
Get the full story at our sister site, MassDevice.