FDA Archives - Page 5 of 15 - TMG Pulse

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FDA Neuro Wearables

FDA approves launch of “largest clinical trial to date” for tDCS depression treatment

Flow Neuroscience, which claims to be the creator of Europe’s first medically approved brain stimulation […]

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Diagnostics FDA MedTech

Cepheid secures FDA EUA for rapid Covid-19 diagnostic test

Cepheid has announced that its Xpert Xpress CoV-2 plus test has received emergency use authorisation (EUA) from […]

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FDA Healthcare MedTech

FDA Drafts Guidance on Medical Device Voluntary Improvement Program

The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation […]

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FDA Implantables Neuro

Synchron enrolls first patient in US COMMAND study of endovascular brain-computer interface

Synchron has announced the enrollment of the first patient in the US COMMAND clinical trial […]

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Drug-delivery FDA MedTech

FDA warns of potential toxic risk from Fresenius hemodialysis machines

The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used […]

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FDA Spine Surgery

Data show superiority of Simplify cervical disc compared to ACDF for the treatment of two-level cervical spondylosis

Results from a two-level multicentre FDA investigational device exemption (IDE) study have shown superior outcomes […]

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FDA Healthcare MedTech

FDA may order Philips to resolve respiratory devices recall

The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory […]

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FDA MedTech Spine

Empirical Spine submits PMA Module II for LimiFlex Dynamic Sagittal Tether

Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug […]

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FDA Pain Management Wearables

Ear-puffing device for migraine treatment wins FDA breakthrough designation

A handheld device that treats migraine attacks with puffs of air in a patient’s ears […]

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Cardiology FDA Implantables

Medtronic investigates HVAD pump welds after patient deaths

Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one […]

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Contract Manufacturing FDA MedTech

MITA: The Time is Right for Clarity on Device Remanufacture

The medical imaging device group, MITA, has voiced support for legislation that calls for clarity […]

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FDA MedTech Neuro

Another setback for Axsome, as migraine med expected to get a no from FDA

Axsome Therapeutics is bracing for another setback as the FDA is now expected to nix […]

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FDA Healthcare MedTech

US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions

On April 8, 2022, the US Food and Drug Administration published a new draft guidance, […]

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FDA Implantables Spine

NuVasive announces positive data for its Simplify cervical disc

NuVasive (Nasdaq:NUVA) today announced data from an FDA investigational device exemption study supporting its Simplify cervical […]

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Cardiology FDA Vascular

Philips says CavaClear used successfully for IVC filter removal

Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC […]

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FDA Robotics Surgery

FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform

Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its […]

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Diagnostics FDA MedTech

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems’ test will […]

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FDA MedTech

FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according […]

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Cardiology FDA Patient Monitoring

LivaNova launches patient monitor for cardiopulmonary bypass procedures

Livanova (Nasdaq:LIVN) announced today that it began the commercial launch of its Essenz patient monitor. London-based […]

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FDA Implantables Orthopedic

FDA clears Ossio’s OssioFiber suture anchors for bone fixation

Ossio announced today that it received the third FDA clearance for its OssioFiber product family in […]

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Cardiology FDA MedTech

ReCor Medical completes enrollment in renal denervation trial for treating hypertension

ReCor Medical announced today that it completed enrollment in its Radiance-II pivotal trial of the […]

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FDA MedTech

Cutera’s AviClear acne device wins FDA clearance

Cutera (Nasdaq:CUTR) announced today that it received FDA 510(k) clearance for its AviClear acne treatment device. […]

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FDA Orthopedic Spine

SpineUp receives 510(k) FDA clearance for Romero cervical cages

SpineUp has been granted 510(k) clearance by the US Food and Drug Administration (FDA) for […]

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FDA MedTech Neuro

Rapid Medical receives FDA Breakthrough Device designation for vasospasm treatment

Rapid Medical has announced US Food and Drug Administration (FDA) Breakthrough Device designation for its Comaneci embolisation assist […]

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FDA MedTech Spine

NuVasive announces expanded indications of use for Attrax Putty

NuVasive has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance […]

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Diagnostics FDA MedTech

FDA grants EUA to Siemens Healthineers’ over-the-counter rapid COVID-19 test

Siemens Healthineers (ETR:SHL) announced that it received FDA emergency use authorization (EUA) for its Clinitest COVID-19 […]

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AI Cardiology FDA MedTech

Another FDA Nod for Firm at the Intersection of Cardiology and AI

Cardiologs has won a nod from FDA for an AI-powered cardiac diagnostics platform for pediatric […]

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FDA MedTech Orthopedic Spine

FDA grants breakthrough device designation for Theradaptive’s spinal fusion implant

Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion […]

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Diagnostics FDA Imaging MedTech

FDA clears Medtronic’s PillCam system for remote endoscopy procedures

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its PillCam Small Bowel 3 […]

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FDA MedTech Robotics Surgery

Vicarious Surgical details its regulatory plans with FDA

Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process […]

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FDA MedTech Neuro

Magnus Medical announces Breakthrough Device designation for novel depression treatment and US$25 million in Series A financing

Magnus Medical has announced that the US Food and Drug Administration (FDA) has granted the […]

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Diagnostics Digital Health FDA MedTech

Siemens’ Varian leads latest FDA breakthrough device designations

Siemens Healthineers’ Varian is among the latest companies to receive FDA breakthrough device designation, securing the […]

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FDA MedTech Orthopedic

Varian wins FDA breakthrough nod for microspheres that treat knee osteoarthritis

Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating […]

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FDA MedTech Neuro

Medtronic receives CE mark approval for radial artery access portfolio

Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes […]

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FDA MedTech

Novocure wins FDA breakthrough designation for liver tumor treatment device

Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment […]

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FDA MedTech

Endosound wins breakthrough device designation for add-on ultrasound system for endoscope

FDA has granted breakthrough device designation to Endosound’s system to turn any flexible upper gastrointestinal […]

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FDA MedTech

Impedimed device gets breakthrough designation for kidney failure

The company’s bioimpedance spectroscopy device would be used to measure how much fluid should be removed from a patient during dialysis.

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FDA MedTech

Philips begins repair and replacement program for recalled DreamStation devices

Royal Philips (NYSE:PHG) announced today that it initiated repair and replacement programs for its recalled sleep […]

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Digital Health FDA Orthopedic

Zimmer Biomet, Canary Medical win FDA de novo nod for smart knee implant

Zimmer Biomet (NYSE:ZBH) and Canary Medical announced today that the FDA granted de novo classification for […]

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Topic: FDA

FDA approves launch of “largest clinical trial to date” for tDCS depression treatment

Cepheid secures FDA EUA for rapid Covid-19 diagnostic test

FDA Drafts Guidance on Medical Device Voluntary Improvement Program

Synchron enrolls first patient in US COMMAND study of endovascular brain-computer interface

FDA warns of potential toxic risk from Fresenius hemodialysis machines

Data show superiority of Simplify cervical disc compared to ACDF for the treatment of two-level cervical spondylosis

FDA may order Philips to resolve respiratory devices recall

Empirical Spine submits PMA Module II for LimiFlex Dynamic Sagittal Tether

Ear-puffing device for migraine treatment wins FDA breakthrough designation

Medtronic investigates HVAD pump welds after patient deaths

MITA: The Time is Right for Clarity on Device Remanufacture

Another setback for Axsome, as migraine med expected to get a no from FDA

US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions

NuVasive announces positive data for its Simplify cervical disc

Philips says CavaClear used successfully for IVC filter removal

FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

FDA can’t explain record-low medical device recalls

LivaNova launches patient monitor for cardiopulmonary bypass procedures

FDA clears Ossio’s OssioFiber suture anchors for bone fixation

ReCor Medical completes enrollment in renal denervation trial for treating hypertension

Cutera’s AviClear acne device wins FDA clearance

SpineUp receives 510(k) FDA clearance for Romero cervical cages

Rapid Medical receives FDA Breakthrough Device designation for vasospasm treatment

NuVasive announces expanded indications of use for Attrax Putty

FDA grants EUA to Siemens Healthineers’ over-the-counter rapid COVID-19 test

Another FDA Nod for Firm at the Intersection of Cardiology and AI

FDA grants breakthrough device designation for Theradaptive’s spinal fusion implant

FDA clears Medtronic’s PillCam system for remote endoscopy procedures

Vicarious Surgical details its regulatory plans with FDA

Magnus Medical announces Breakthrough Device designation for novel depression treatment and US$25 million in Series A financing

Siemens’ Varian leads latest FDA breakthrough device designations

Varian wins FDA breakthrough nod for microspheres that treat knee osteoarthritis

Medtronic receives CE mark approval for radial artery access portfolio

Novocure wins FDA breakthrough designation for liver tumor treatment device

Endosound wins breakthrough device designation for add-on ultrasound system for endoscope

Impedimed device gets breakthrough designation for kidney failure

Philips begins repair and replacement program for recalled DreamStation devices

Zimmer Biomet, Canary Medical win FDA de novo nod for smart knee implant