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BioWorld - Thursday, June 19, 2025
Home » Topics » Regulatory » PMA

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Sequana Medical's Alfapump system

Sequana gets FDA nod for Alfapump to treat patients with ascites

Dec. 30, 2024
By Shani Alexander
Sequana Medical NV received premarket approval from the U.S. FDA for its Alfapump system to treat recurrent or refractory ascites due to liver cirrhosis. Data from the Poseidon pivotal study showed the implantable device, which removes ascites from the abdomen into the bladder, can eliminate the need for therapeutic paracentesis, improving the quality of life of patients.
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Merit Wrapsody

Merit unwraps Wrapsody endoprosthesis PMA for the holidays

Dec. 20, 2024
By Holland Johnson
Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
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Insulet’s Omnipod 5 FDA cleared for type 2 diabetes patients

Aug. 27, 2024
By Holland Johnson
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.
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Abbott wins approval for Triclip tricuspid valve repair system

April 2, 2024
By Holland Johnson
Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
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Boston Scientific Corporation AGENT Drug Coated Balloon

FDA approves ‘needle-moving’ Boston Scientific’s Agent balloon

March 1, 2024
By Annette Boyle
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
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Boston Scientific Wavewriter Alpha spinal cord stimulation system

Boston Sci’s Wavewriter surfs to FDA approval for non-surgical back pain

Feb. 8, 2024
By Annette Boyle
Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.
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FDA accepts Novocure’s PMA application for lung cancer treatment technology

Jan. 29, 2024
By Shani Alexander
The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.
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Avita Recell device

Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

June 21, 2023
By Tamra Sami
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
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Avita Recell device

FDA approval gives Avita’s Recell room for healthy growth

June 8, 2023
By Annette Boyle
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
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Xenoview in lungs in MRI

Polarean Imaging wins FDA nod for hyperpolarized MRI contrast agent

Dec. 30, 2022
By Meg Bryant
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
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