[Image from Magstim]
Magstim announced today that it received FDA 510(k) clearance for its Horizon 3.0 transcranial magnetic stimulation platform.Horizon 3.0 offers enhanced workflows with navigated transcranial magnetic stimulation (TMS) and analytics for the clinical setting, offering connected care at networked sites, according to a news release.
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(Image courtesy of the FDA)
The FDA’s exciting new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.Craig Coombs and Qiang Kou, Nyquist Data
The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML.
Extracting this information from the FDA’s decades-old database is labor-intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review.
Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours?
Get the full story at our sister site, MassDevic…
Craig Coombs and Qiang Kou, Nyquist Data
The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML.
Extracting this information from the FDA’s decades-old database is labor-intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review.
Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours?
Like many databases, the FDA database uses text-matching to find relevant entries. The weakness of text-matching…
The FDA today confirmed a Class I recall for the Zimmer Biomet (NYSE:ZBH) Rosa One 3.1 Brain Application platform for robot-assisted neurosurgery procedures.
Zimmer Biomet sent an urgent medical device correction on Sept. 22 for the platform as a result of a software error. Affected devices — of which there were 119 total in the U.S. — were distributed between Dec. 1, 2019, and Aug. 31, 2021, according to an FDA notice.
The company recalled the product due to a software error that could lead to the incorrect placement of instruments during stereotactic neurosurgical procedures, which could result in adverse events including stroke, serious injury, severe disability and death.
In total, there have been three complaints about the device issue with zero deaths or injuries reported.
Warsaw, Indiana-based Zimmer Biomet designed the Rosa One 3.1 Brain Application to help neurosurgeons with positioning medical instruments or implants during surgery. The …
Guilford, Connecticut-based Detect develops a molecular rapid test designed to identify SARS-CoV-2, the virus causing COVID-19, at lower viral loads than antigen tests to allow for earlier detection, according to a news release.
The Detect COVID-19 test, which can be done entirely at home in one hour, demonstrated 97.3% overall agreement with 90.9% sensitivity and 100% specificity when test results were interpreted correctly in comparison with a highly sensitive PCR test in clinical studies. The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Initiative (RADxSM) recently selected Detect’s test for an $8.1 million contract to scale up manufacturing.
Retail pricing for the Detect test will come in under $50, the company said. It will be used in schools and workplaces for regular screening prog…
Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference in early November, pending an interim analysis in October.
Significantly positive results would have advanced Medtronic’s efforts for FDA approval, but the independent data safety monitoring board conducting that analysis — meant to end trial enrollment if results are significantly better or worse than expected — recommended that Medtronic continue enrolling patients.
Get the full story at our sister site, Medical Des…
The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) will continue the Spyral clinical study of its Symplicity renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early.Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference in early November, pending an interim analysis in October.
Significantly positive results would have advanced Medtronic’s efforts for FDA approval. But the independent data safety monitoring board conducting that analysis — meant to end trial enrollment if results are significantly better or worse than expected — recommended that Medtronic continue enro…
Crystal Lake, Illinois-based Aptar’s patented Cartridge Pump System (CPS), designed for the multidose delivery of preserved and non-preserved drug formulations, received approval as the device for delivering Oyster Point Pharma’s Tyrvaya (varenicline solution) nasal spray (0.03 mg).
Get the full story at our sister site, Drug Delivery Business News.
South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Get the full story at our sister site, Drug Delivery Business News.
The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities.
He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days, compared to 7.7 percent of patients whose procedures used reusable scopes.
Get the full story at our sister site, Medical Design & Outsourcing.
The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated.
Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility.
The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or more after the first.
The Pfizer-BioNTech and Moderna boosters are available to fully vaccinated people 65 or older, provided six months have elapsed after receipt of the last dose. In addition, individuals 18 and older who live in a long-term care facility are also eligible. Those who live or work in high-risk settings also can get the shot, as can individuals with certain medical conditions.
When asked when FDA would authorize boosters to all individuals 18 and older, Dr. Peter Marks, a senior official at FDA, said in a media briefing, “I think we may get…
Photo by Aaron Kittredge from Pexels
The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.
The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.
Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.
An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.
The White House said it would begin dispensing shots with…