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Home » Topics » Regulatory » 510(k)

510(k)
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'Clerical errors' common trigger for rejected special 510(k)s

Nov. 1, 2019
By Mark McCarty
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
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FDA Approved seal

Heartvista's AI-assisted cardiac MRI tool cleared

Oct. 30, 2019
By Meg Bryant
Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
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FDA says the refuse-to-accept rate for dental device 510(k)s greater than 80%

Oct. 25, 2019
By Mark McCarty
Dental devices would likely strike most observers as fairly simple items, but an FDA employee said on a recent webinar that these filings have a refuse-to-accept (RTA) rate in excess of 80%, suggesting sponsors have a lot of regulatory homework to do. The FDA finalized the RTA policy for 510(k) devices in September 2019, wrapping up a draft that originated in 2012, but which is on the second iteration.
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Think Surgical gets FDA nod for Tsolution One

Oct. 11, 2019
By Liz Hollis
Think Surgical Inc., of Fremont, Calif., won good news from the U.S. FDA, which cleared the company's Tsolution One total knee application for use in total knee arthroplasty (TKA). The Tsolution One total knee application includes computed tomography-based 3D presurgical planning software, providing surgeons the ability to design and prepare the patient's knee joint replacement plan. During surgery, the physician puts the patient's pre-planned procedure using the robot into effect, with the goal of precisely placing the knee implants.
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Medtronic files for FDA approval of Interstim Micro, Surescan MRI leads

Oct. 8, 2019
By Meg Bryant
Dublin-based Medtronic plc has filed a PMA supplement with the U.S. FDA for its next-generation, implantable sacral neuromodulation (SNM) device, Interstim Micro, and for its Interstim Surescan MRI leads. Interstim Micro is intended to help patients with overactive bladder (OAB), urinary urge incontinence, unobstructed urinary retention and fecal incontinence (FI).
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Exogenesis gets FDA OK to market first hernia mesh with nano-modified surface

Oct. 4, 2019
By Meg Bryant
The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.
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FDA resets performance guidance along with four product-specific guidances

Sep. 20, 2019
By Mark McCarty

FDA unveils expedited review program for safer medical devices

Sep. 19, 2019
By Mark McCarty
The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.
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FDA retains 'well-defined' restriction in special 510(k) final

Sep. 13, 2019
By Mark McCarty
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