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Home » Topics » Regulatory » De novo

De novo
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Toy bulldozer moving FDA letter blocks

FDA provides five more device classifications via de novo petition

Feb. 18, 2022
By Mark McCarty
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
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FDA icons

FDA announces four new class II device designations

Feb. 7, 2022
By Mark McCarty
The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
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Hand holding FDA blocks

Class II designation finally effective for cerebrospinal fluid shunts

Dec. 31, 2021
By Mark McCarty
Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.
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FDA icons

FDA’s pressure on 510(k) process a factor in lawsuit between J&J, Auris

Dec. 16, 2021
By Mark McCarty
The FDA’s regulation of medical technology may be assumed to have a number of unintended consequences, and one of those seems to be the lawsuit between Johnson & Johnson (J&J) and Auris Health Inc. Due to a 2018 FDA policy change regarding 510(k) devices, a robotic surgery system acquired by a J&J subsidiary from Auris was forced into the lengthier de novo premarket channel. This change ultimately helped derail the development effort for the Auris Iplatform surgical system and thus played a role in the $2.35 billion lawsuit alleging that J&J had engaged in fraud in its deal with Auris over the acquisition.
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Hand holding FDA blocks

FDA slots five device types into class II, including for de novo granted in 2011

Dec. 1, 2021
By Mark McCarty
The FDA’s device center is required to develop and publish special controls for devices that are deemed class II items via the de novo petition process, and five such declarations were posted Dec. 1 to the Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.
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Doctor, patient using Hemolung

Hemolung respiratory assist system gets de novo nod

Nov. 15, 2021
By Annette Boyle
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
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Digital heart illustration

Feops Heartguide granted FDA de novo authorization for LAAo planning

Oct. 15, 2021
By Catherine Longworth
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
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U.S. FDA headquarters

FDA retains pre-inspection features in final rule for de novo petitions

Oct. 5, 2021
By Mark McCarty
The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications.
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Woman using Paige software on tablet

Paige receives FDA de novo authorization for AI product for prostate cancer detection

Sep. 22, 2021
By Annette Boyle
The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.
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Gold wireframe handshake

Zimmer, Canary advance the cause of digital orthopedics with smart knee implant

Aug. 30, 2021
By Mark McCarty
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.
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