FDA Approved Archives - TMG Pulse

VisAR, an augmented reality surgical navigation system from healthcare technology company Novarad, has received US […]

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FDA Approved Implantables Neuro

Valencia Technologies announces first commercial implantation of eCoin tibial neurostimulator

Valencia Technologies Corporation has announced in a press release that it has completed the “world’s […]

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FDA Approved Implantables Orthopedic

FX Solutions secures FDA 510k approval for FX V135 platform

FX Solutions has received US Food and Drug Administration (FDA) 510k approval for its new FX V135 […]

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Cardiology FDA Approved Structural Heart

Medtronic Wins FDA Nod for Onyx Frontier DES

Medtronic said it has won FDA approval for the Onyx Frontier drug-eluting stent (DES). The […]

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Cardiology FDA Approved Implantables

FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent

Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent […]

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Cardiology FDA Approved Surgery

Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes

Abbott (NYSE:ABT) announced today that its Xience Skypoint drug-eluting stent platform is now available globally. […]

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CE Mark FDA Approved Surgery

Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

Hologic received approval from the Food and Drug Administration for an assay to quantify the viral load of […]

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Cardiology FDA Approved Neuro

FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system

CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim […]

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FDA Approved Ophthalmology Wearables

Johnson & Johnson Vision wins Fast Company award for drug-eluting contact lens

Johnson & Johnson Vision announced today that it was named a winner of Fast Company’s […]

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Cardiology FDA Approved Surgery

Silk Road Medical announces FDA approval of expanded indications for the Enroute transcarotid stent system

Silk Road Medical recently announced that the US Food and Drug Administration (FDA) approved expanded […]

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Cardiology FDA Approved Implantables

FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices

Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management […]

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FDA Approved Imaging Neuro

Boston Scientific wins FDA approval for imaged-guided software for DBS therapy

Boston Scientific (NYSE:BSX) today announced it received FDA approval for its Vercise Neural Navigator with StimView […]

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FDA Approved Imaging Vascular

Bendit receives FDA 510(k) clearance for 0.021-inch steerable microcatheter

Bendit Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of its Bendit21 […]

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Drug-delivery FDA Approved Healthcare

FDA approves GE Healthcare software that automates anesthesia, reduces greenhouse gas emissions during surgery

GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control […]

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Biotech FDA Approved Ophthalmology

Bausch + Lomb, Clearside Biomedical launch Xipere in U.S.

Bausch Health’s (NYSE:BHC) Bausch + Lomb and Clearside Biomedical (NSDQ:CLSD) today launched their Xipere product […]

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FDA Approved MedTech Neuro

Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from DPN

Medtronic has received US Food and Drug Administration (FDA) approval of its Intellis rechargeable neurostimulator […]

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Cardiology FDA Approved MedTech Vascular

FDA approves Philips’ laser-based device for removing inferior vena cava filters

The FDA today announced the authorization of the first laser-based device for removing IVC filters, […]

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FDA Approved MedTech

OrganOx wins FDA PMA for its donor liver transport device

OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion […]

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FDA Approved Imaging MedTech

Delphinus receives FDA clearance for ultrasound breast cancer screening tech

The SoftVue system is intended to be used in addition to digital mammograms to screen for cancer among patients with dense breast tissue.

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FDA Approved MedTech Vascular

Haemonetics wins FDA nod for same-day discharge following AFib ablation using Vascade MVP

Haemonetics today said that it has received FDA approval for same-day discharge after atrial fibrillation […]

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Cardiology FDA Approved MedTech Vascular

Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav

Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system. The […]

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Cardiology FDA Approved MedTech

FDA approves TransMedics’ OCS Heart system

TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system. Andover, […]

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FDA Approved Pharmaceutical

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

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FDA Approved MedTech Neuro

MicroTransponder gains FDA approval for first-of-its-kind VNS system to improve stroke rehabilitation

MicroTransponder has announced US Food and Drug Administration (FDA) premarket approval of the Vivistim paired […]

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FDA Approved Implantables Neuro

FDA approves first vagus nerve stimulation implant for stroke rehabilitation

The FDA approved its first nerve stimulation device designed to help people suffering from the […]

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FDA Approved MedTech

Medtronic’s Newest TAVR Is a ‘Home Run’ on Deployment Predictability

The latest generation of Medtronic’s self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX, is designed to enhance ease-of-use and predictable valve deployment.

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FDA Approved Healthcare Pharmaceutical

FDA approves Pfizer-BioNTech COVID-19 vaccine

The regulatory decision clears the way for more vaccine mandates in the U.S.

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Cardiology FDA Approved MedTech

FDA approves Abbott Amplatzer Amulet to treat AFib

Abbott today announced that it has received FDA approval for its Amplatzer Amulet device to […]

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Cardiology FDA Approved MedTech

Abbott’s Amulet FDA approval sets stage for US market fight with Boston Scientific

Dive Brief: Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder device used […]

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Drug-delivery FDA Approved

FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion

Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its […]

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FDA Approved Neuro

FDA approves Zoll Respicardia’s next-gen Remedē system

Zoll Medical, an Asahi Kasei company, announced today that the FDA has approved its next-gen […]

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FDA Approved MedTech Spine

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic […]

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FDA Approved MedTech Neuro

Medtronic bags FDA approval for Vanta implantable neurostimulator

Medtronic has received US Food and Drug Administration (FDA) approval for its Vanta device–a recharge-free […]

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Diagnostics FDA Approved Oncology Pharmaceutical

Cardinal Health wins new FDA approval for Lymphoseek

Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. […]

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FDA Approved Implantables MedTech

FDA approves “first-of-its-kind” SenSight Directional Lead System for DBS therapy

Medtronic has announced US Food and Drug Administration (FDA) approval and first US implants of […]

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FDA Approved Implantables Neuro

Medtronic gains FDA approval to trial implantable tibial neuromodulation device

Medtronic has announced approval from the US Food and Drug Administration (FDA) to proceed with […]

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FDA Approved MedTech

FDA approves Medtronic Pipeline Flex with Shield Technology to treat brain aneurysms

Medtronic has received US Food and Drug Administration (FDA) approval for the Pipeline Flex embolization […]

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FDA Approved Implantables MedTech Spine

NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR

NuVasive has gained FDA approval for its Simplify Cervical Artificial Disc, allowing the device to […]

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Cardiology FDA Approved Surgery Vascular

Medtronic’s Harmony pulmonary valve wins FDA approval

Dive Brief: FDA on Friday said it approved Medtronic’s catheter-based treatment for pediatric and adult […]

Topic: FDA Approved

3D augmented reality surgical navigation system achieves FDA approval for precision spine surgery

Valencia Technologies announces first commercial implantation of eCoin tibial neurostimulator

FX Solutions secures FDA 510k approval for FX V135 platform

Medtronic Wins FDA Nod for Onyx Frontier DES

FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent

Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes

Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system

Johnson & Johnson Vision wins Fast Company award for drug-eluting contact lens

Silk Road Medical announces FDA approval of expanded indications for the Enroute transcarotid stent system

FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices

Boston Scientific wins FDA approval for imaged-guided software for DBS therapy

Bendit receives FDA 510(k) clearance for 0.021-inch steerable microcatheter

FDA approves GE Healthcare software that automates anesthesia, reduces greenhouse gas emissions during surgery

Bausch + Lomb, Clearside Biomedical launch Xipere in U.S.

Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from DPN

FDA approves Philips’ laser-based device for removing inferior vena cava filters

OrganOx wins FDA PMA for its donor liver transport device

Delphinus receives FDA clearance for ultrasound breast cancer screening tech

Haemonetics wins FDA nod for same-day discharge following AFib ablation using Vascade MVP

Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav

FDA approves TransMedics’ OCS Heart system

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

MicroTransponder gains FDA approval for first-of-its-kind VNS system to improve stroke rehabilitation

FDA approves first vagus nerve stimulation implant for stroke rehabilitation

Medtronic’s Newest TAVR Is a ‘Home Run’ on Deployment Predictability

FDA approves Pfizer-BioNTech COVID-19 vaccine

FDA approves Abbott Amplatzer Amulet to treat AFib

Abbott’s Amulet FDA approval sets stage for US market fight with Boston Scientific

FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion

FDA approves Zoll Respicardia’s next-gen Remedē system

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

Medtronic bags FDA approval for Vanta implantable neurostimulator

Cardinal Health wins new FDA approval for Lymphoseek

FDA approves “first-of-its-kind” SenSight Directional Lead System for DBS therapy

Medtronic gains FDA approval to trial implantable tibial neuromodulation device

FDA approves Medtronic Pipeline Flex with Shield Technology to treat brain aneurysms

NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR

Medtronic’s Harmony pulmonary valve wins FDA approval