https://www.bioworld.com/rss en-us holland.johnson@clarivate.com A U.S. FDA advisory panel voted unanimously against approving Johnson & Johnson’s V-Wave Ventura shunt for heart failure patients not helped by medications. The circulatory panel voted emphatically 15-0 against use of the shunt for heart failure patients not helped by medications based on effectiveness and its benefit-risk profile. On the question of safety, the panelists did vote 9-6 in favor of the device. http://www.bioworld.com/articles/726720 Mon, 08 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/726720-j-and-j-v-wave-heart-shunt-shut-down-by-fda-advisory-panel V-Wave Johnson & Johnson V-Wave ventura shunt. Credit: Johnson & Johnson China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability. http://www.bioworld.com/articles/724566 Tue, 23 Sep 2025 12:00:00 -0400 https://www.bioworld.com/articles/724566-china-a-great-ai-med-tech-market-but-premarket-review-unpredictable 3D map of China China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability. http://www.bioworld.com/articles/724111 Wed, 17 Sep 2025 12:00:00 -0400 https://www.bioworld.com/articles/724111-china-a-great-ai-med-tech-market-but-premarket-review-unpredictable 3D map of China Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment. http://www.bioworld.com/articles/724100 Tue, 16 Sep 2025 12:00:00 -0400 https://www.bioworld.com/articles/724100-fda-approves-biocartis-idylla-cdx-msi-colorectal-cancer-test Idylla platform Idylla is a fully automated, real-time PCR based molecular testing system. Credit: Biocartis Group NV Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance. http://www.bioworld.com/articles/723563 Wed, 03 Sep 2025 12:00:00 -0400 https://www.bioworld.com/articles/723563-kardiums-globe-pfa-system-gains-fda-approval Single Shot PVI Kardium Inc.’s Globe integrated mapping and pulsed field ablation system. Credit: Kardium Inc. holland.johnson@clarivate.com Medtronic plc reported that its soon-to-be spun out diabetes business scored two key regulatory wins. http://www.bioworld.com/articles/723551 Tue, 02 Sep 2025 12:00:00 -0400 https://www.bioworld.com/articles/723551-medtronic-gets-fda-ok-to-integrate-minimed-with-abbotts-instinct Deal-merger-money-lightbulb.png holland.johnson@clarivate.com Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer. http://www.bioworld.com/articles/723194 Thu, 21 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723194-novocure-files-pma-for-use-of-optune-in-pancreatic-cancer-treatment Novocure's Optune Lua Novocure’s Optune Lua TTFields device for treating non-small-cell lung cancer. Credit: courtesy Novocure GmbH holland.johnson@clarivate.com Nyxoah SA may now help make dreams come true here in the U.S. with its FDA approval for the Genio system for the treatment of obstructive sleep apnea. http://www.bioworld.com/articles/722837 Tue, 12 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/722837-nyxoah-wins-fda-approval-for-genio-osa-treatment Nyxoah Genio holland.johnson@clarivate.com Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries. http://www.bioworld.com/articles/722682 Fri, 08 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/722682-instylla-wins-fda-pma-for-embrace-hydrogel-embolic-system Instylla Inc Embrace Instylla Inc. Embrace hydrogel embolic system. Credit: Instylla 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. http://www.bioworld.com/articles/715569 Mon, 30 Dec 2024 11:00:00 -0500 https://www.bioworld.com/articles/715569-sequana-gets-fda-nod-for-alfapump-to-treat-patients-with-ascites Sequana Medical's Alfapump system Sequana Medical's Alfapump system holland.johnson@clarivate.com 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. http://www.bioworld.com/articles/715234 Fri, 20 Dec 2024 11:00:00 -0500 https://www.bioworld.com/articles/715234-merit-unwraps-wrapsody-endoprosthesis-pma-for-the-holidays Merit Wrapsody The Wrapsody cell-impermeable endoprosthesis. Credit: Courtesy of Merit Medical Systems. holland.johnson@clarivate.com 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. http://www.bioworld.com/articles/711599 Tue, 27 Aug 2024 12:00:00 -0400 https://www.bioworld.com/articles/711599-insulets-omnipod-5-fda-cleared-for-type-2-diabetes-patients Omnipod 5 Omnipod 5. Credit: Insulet Corp. holland.johnson@clarivate.com 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. http://www.bioworld.com/articles/706901 Tue, 02 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/706901-abbott-wins-approval-for-triclip-tricuspid-valve-repair-system 4-9-Abbott-Triclip.png Triclip device. Credit: Abbott Laboratories 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. http://www.bioworld.com/articles/705881 Fri, 01 Mar 2024 11:00:00 -0500 https://www.bioworld.com/articles/705881-fda-approves-needle-moving-boston-scientifics-agent-balloon Boston Scientific Corporation AGENT Drug Coated Balloon Boston Scientific Corp.’s Agent paclitaxel-coated balloon. Credit: Boston Scienctific Corp. 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. http://www.bioworld.com/articles/705081 Thu, 08 Feb 2024 11:00:00 -0500 https://www.bioworld.com/articles/705081-boston-scis-wavewriter-surfs-to-fda-approval-for-non-surgical-back-pain Boston Scientific Wavewriter Alpha spinal cord stimulation system Boston Scientific Corp.’s Wavewriter systems received FDA approval for use in non-surgical back pain. Credit: Courtesy Boston Scientific. 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. http://www.bioworld.com/articles/704922 Mon, 29 Jan 2024 11:00:00 -0500 https://www.bioworld.com/articles/704922-fda-accepts-novocures-pma-application-for-lung-cancer-treatment-technology Product image NovoTTF-100L system. Credit: Novocure Ltd. 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. http://www.bioworld.com/articles/698180 Wed, 21 Jun 2023 12:00:00 -0400 https://www.bioworld.com/articles/698180-avitas-recell-gains-fda-greenlight-for-skin-repigmentation-in-vitiligo Avita Recell device Recell spray-on-skin device. Credit: Avita 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.” http://www.bioworld.com/articles/697783 Thu, 08 Jun 2023 12:00:00 -0400 https://www.bioworld.com/articles/697783-fda-approval-gives-avitas-recell-room-for-healthy-growth Avita Recell device Recell spray-on-skin device. Credit: Avita Medical Inc. 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. http://www.bioworld.com/articles/692930 Fri, 30 Dec 2022 13:00:00 -0500 https://www.bioworld.com/articles/692930-polarean-imaging-wins-fda-nod-for-hyperpolarized-mri-contrast-agent Xenoview in lungs in MRI Magnetic resonance images of the lung taken with Xenoview technology. Credit: Polarean Imaging plc The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia. http://www.bioworld.com/articles/521047 Tue, 26 Jul 2022 13:00:00 -0400 https://www.bioworld.com/articles/521047-acufocus-secures-fda-approval-for-apthera-lens IC-8 Apthera IOL box The IC-8 Apthera intraocular lens was approved for the treatment of cataracts. Credit: Acufocus Inc. The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts. http://www.bioworld.com/articles/518367 Fri, 29 Apr 2022 13:00:00 -0400 https://www.bioworld.com/articles/518367-transmedics-expands-fda-pma-approval-for-heart-transplant-system Gloved hands holding a heart Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision. http://www.bioworld.com/articles/517866 Tue, 12 Apr 2022 13:00:00 -0400 https://www.bioworld.com/articles/517866-fda-approval-stimulates-boston-scientifics-neural-navigator Vercise Neural Navigator with Stimview XT software on tablet Boston Scientific Corp.’s Stimview XT. Axonics Inc. received FDA approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for bladder and bowel dysfunction. The F15’s primary cell requires no recharging or replacement for more than 15 years with normal use or 20 years at lower energy settings and the system is compatible with 1.5T and 3.0T full body magnetic resonance imaging scans. http://www.bioworld.com/articles/516767 Tue, 08 Mar 2022 13:00:00 -0500 https://www.bioworld.com/articles/516767-fda-approves-axonics-recharge-free-sacral-neuromodulation-system FDA approved icons and medical professional The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade. http://www.bioworld.com/articles/516495 Mon, 28 Feb 2022 12:00:00 -0500 https://www.bioworld.com/articles/516495-us-fda-says-first-cycle-pma-major-deficiency-rates-spiked-in-cy-2021 Stepped arrow At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022. http://www.bioworld.com/articles/516010 Fri, 11 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/516010-senseonics-receives-fda-approval-for-long-lasting-eversense-e3-cgm Eversense sensor and apps Eversense CGM system. Credit: Senseonics Holding Inc. Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN). http://www.bioworld.com/articles/515407 Mon, 24 Jan 2022 13:00:00 -0500 https://www.bioworld.com/articles/515407-with-fda-approval-medtronic-challenges-nevro-in-pdn-market Intellis device image Medtronic plc’s Intellis spinal cord stimulator In a move that will substantially expand the number of livers available for transplantation, the FDA granted premarket approval to Organox Ltd.’s Metra normothermic machine perfusion device for both donors after brain death (DBD) and donors after circulatory death (DCD). The approval allows preservation of organs by Metra for up to 12 hours. http://www.bioworld.com/articles/514683 Wed, 29 Dec 2021 13:00:00 -0500 https://www.bioworld.com/articles/514683-fda-greenlights-organox-metra-to-preserve-donated-livers FDA icons Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days. http://www.bioworld.com/articles/510881 Fri, 27 Aug 2021 13:00:00 -0400 https://www.bioworld.com/articles/510881-fda-greenlights-first-vns-based-stroke-rehabilitation-system Diagram showing how Vivistim works Positioning the Vivistim Paired VNS System. Credit: Microtransponder Inc. The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022. http://www.bioworld.com/articles/510821 Wed, 25 Aug 2021 13:00:00 -0400 https://www.bioworld.com/articles/510821-fda-approves-medtronics-evolut-fx-tavr-system-for-patients-with-severe-aortic-stenosis Evolut FX image Evolut FX TAVR system. Credit: Medtronic plc Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term. http://www.bioworld.com/articles/510489 Mon, 16 Aug 2021 13:00:00 -0400 https://www.bioworld.com/articles/510489-fda-approves-abbotts-amplatzer-amulet-laa-occluder-for-afib 2-3-abbott-amplatzer-amulet.png Amplatzer Amulet device. Credit: Abbott Laboratories