Aatru Medical LLC has received FDA 510(k) class II clearance for a platform that turns its back on electro-mechanical components in other negative pressure wound therapy (NPWT) systems. Deployed for closed surgical incision applications, the Negative Pressure Surgical Incision Management System (NPSIMS) is a single-use, disposable platform that could help reduce the 20% of hospital infections attributed to surgical site infections (SSI).
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17.
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting.
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
Higher antibody titer levels were found in participants receiving two doses of Moderna Inc.’s COVID-19 vaccine compared to those receiving the Pfizer Inc.-Biontech SE vaccine, according to a research letter published in JAMA.
Digital health has made only limited headway in the orthopedics space, but Zimmer Biome Inc. and Canary Medical Inc. have nudged the cause along with a smart implant that blends a 21st century sensor with a traditional knee replacement device. The marriage of Zimmer’s Persona knee implant and the Canary Medical Canturio TE sensor will give physicians a better way to track the patient’s recovery from knee replacement procedures.
The FDA has released two draft guidances under the safety and performance-based pathway for class II devices, proving some much-needed momentum for the agency’s fiscal year 2021 guidance agenda. The two drafts address performance metrics for facet screw systems and the use of resins in dentures, thus adding substantially to the number of class device types that can be reviewed outside the usual substantial equivalence mechanism ordinarily relied upon in the 510(k) program. The FDA began implementing the safety and performance-based pathway for devices in late 2019, an approach that serves as a substitute for the abbreviated 510(k) mechanism.
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