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Home » Topics » Regulatory

Regulatory
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MITA urges FDA to make numerous technical changes to performance draft for MRI coils

Feb. 11, 2020
By Mark McCarty
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
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Logicbio shares sink as FDA hold delays plans to launch phase I/II trial

Feb. 11, 2020
By Michael Fitzhugh
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA).
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Varian receives FDA nod for Ethos therapy

Feb. 11, 2020
By Liz Hollis
Palo Alto, Calif.-based Varian Medical Systems Inc. has won the U.S. FDA’s nod for its Ethos therapy, an artificial intelligence (AI)-driven holistic solution that is aiming to transform cancer care. This solution is designed to deliver an entire adaptive treatment in a typical 15-minute slot and is intended to put the patient at the center of care, noted Chris Toth, president of Varian Oncology Systems.
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Fate of California law could dictate future of Rx patent settlements

Feb. 11, 2020
By Mari Serebrov
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements.
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Regulatory front for Feb. 11, 2020

Feb. 11, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Feb. 10, 2020

Feb. 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aethlon Medical.
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FDA gives green light to software that helps in the acquisition of cardiac ultrasound images

Feb. 10, 2020
By Liz Hollis
Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
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Thumbs up

Irish startup Atlantic goes OTC in the U.S. with wearable treatment for urinary incontinence

Feb. 10, 2020
By Stacy Lawrence
The FDA has granted over-the-counter (OTC) clearance to the first noninvasive wearable to treat stress urinary incontinence. The device, known as Innovo, uses electrical stimulation to strengthen pelvic floor muscles and is integrated into fitted shorts. It was already available by physician prescription in the U.S. since an FDA clearance in early 2019.
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Approved stamp

Carmat wins OK from the FDA for its U.S. clinical feasibility study

Feb. 10, 2020
By Bernard Banga
PARIS – Carmat SA, from Vélizy-Villacoublay, France, has obtained full FDA approval for its investigational device exemption application (IDE). The company is now able to initiate a U.S. early feasibility study (EFS) of its total artificial heart. “This full approval to initiate a U.S. study confirms the FDA’s confidence in our ability to conduct a feasibility study of the first bio-prosthetic artificial heart in the United States,” Stéphane Piat, CEO of Carmat, told BioWorld.
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Regulatory front for Feb. 10, 2020

Feb. 10, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Acetris, Aurolife.
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