The U.S. FDA granted breakthrough device designation to startup Brainspec Inc. for its non-invasive virtual brain biopsy system. The company uses standard magnetic resonance imaging equipment to measure brain chemistry rather than to create images, providing a more detailed view of pathophysiology involved in a range of neurological disorders.
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.
Akadeum Life Sciences Inc. is rolling out a new dead cell removal kit using its patented microbubble technology. The research-use-only Dead Cell Removal Microbubble Kit (DCR kit) is currently available via direct sales to the U.S. market and on the company’s website. Akadeum’s DCR kit is designed to resolve current challenges in dead cell removal, which can hamper elimination of dead cells and the salvage of viable ones for research use.
Valentine’s Day is a great day for creating that tingly feeling, but Abbott Park, Ill.-based Abbott Laboratories believes that this is not a good sensation for patients who are in search of pain relief via spinal cord stimulation (SCS) devices. Thus, the company touts its Proclaim Plus as a system that delivers a tightly titrated charge to multiple sites on the spinal cord to generate an analgesic effect without that tingling sensation, an outcome the company said is preferred by 87% of those in need of SCS for pain relief.
Medical device product liability litigation can take a number of seemingly unique twists and turns, but the case of Nelson v. Bard took a path that might have been predicted based on FDA-mandated labeling content. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court’s ruling that the instructions for use for a Bard inferior vena cava filter indemnified the company because the IFU listed the very events seen by the patient, undercutting the patient’s claim that Bard had failed to warn of these events.
Precision Diabetes Inc. (PDI) entered an exclusive agreement with Dxgen Corp. to introduce and distribute the Epithod Autodx point-of-care analyzer and multiple diabetes tests that run on the system within the U.S. The first available tests will include hemoglobin A1c, C-reactive protein and albumin, with the portfolio of tests expected to grow quickly.
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden.
The field of artificial intelligence (AI) is beginning to mature, but this is also becoming a competitive space, with several governmental entities declaring their intent to develop policies to maintain national competitiveness. The U.S. has now entered the fray with a request for information by the International Trade Administration seeking information on policies that might foster the export of AI products developed by U.S. companies, but also on the policies that might enable small and medium enterprises to remain competitive.
“It’s now law,” U.S. President Joe Biden said after he signed H.R. 5376 Aug. 16. His signature made Medicare drug pricing negotiations a near-term reality, along with new inflationary rebates, new caps on annual out-of-pocket drug spending and monthly insulin copays for Medicare beneficiaries, and tax changes that could affect the bottom line for several multinational drug and device companies beginning next year.
The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia.
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