A new report by the Congressional Research Service (CRS) revives the question of U.S. FDA regulation of lab-developed tests (LDTs). However, attorney Jeffrey Shapiro, of Washington-based Hyman Phelps & McNamara PC, told BioWorld that the agency is no longer in a position to unilaterally impose a regulatory regime on LDTs, and that there is little likelihood that any enabling legislation will pass until at least 2021.
The U.S. FDA has granted breakthrough device designation to Mojo Vision Inc. for its first-of-a-kind true smart contact lens. The Mojo Lens, which features “invisible computing” and a built-in display, enables people to get timely information without having to look away from what they are doing or glance at a screen.
Transenterix Inc., of Research Triangle Park, N.C., said Tuesday that it has filed a 510(k) submission with the U.S. FDA for the Intelligent Surgical Unit (ISU), a machine vision system designed to work with its robotic Senhance surgical system. The new technology would equip users of the Senhance system with augmented intelligence to improve performance and surgical outcomes.
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.
In the latest step toward making left ventricular assist devices (LVADs) easier and more accessible, the FDA recently approved a less invasive surgical approach for use with Abbott Laboratories’ latest LVAD, Heartmate 3. Now, rather than requiring risky open-heart surgery, the device can be implanted through an incision in the chest wall. Abbott gained Heartmate 3 in its 2017 acquisition of St. Jude Medical for $25 billion.
The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
LAS VEGAS – The U.S. FDA has said it is looking to help those interested in developing digital health tools, and that commitment took center stage this week during the Digital Health Summit, part of CES 2020. Amy Abernethy, principal deputy commissioner at the FDA, gave an overview of the agency’s thinking on the topic, providing the perspective of someone who came from outside the regulatory world.
Caesarea, Israel-based Icecure Medical Ltd. has won the FDA’s nod for additional indications for its cryoablation technology, paving the way for use in kidney, liver, ear, nose and throat and new neurology indications. The agency also cleared Icecure’s new Multisense system.
Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
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