FDA Archives - Page 10 of 15 - TMG Pulse

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FDA Healthcare Patient Monitoring

FDA eases rules on remote patient monitoring devices during pandemic

The FDA has relaxed regulations on 21 types of remote patient monitoring devices for the […]

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FDA Healthcare Patient Monitoring

FDA eases rules on remote patient monitoring devices during pandemic

The FDA has relaxed regulations on 21 types of remote patient monitoring devices for the […]

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FDA Pain Management Spine

GTX Medical wins FDA breakthrough device designation for targeted epidural spinal stimulation

GTX Medical this week said it received FDA breakthrough device designation for its Go-2 targeted […]

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FDA MedTech

Boston Scientific secures CMS pass-through nod for single-use endoscopes

Dive Brief: Boston Scientific on Monday said CMS approved its application for a transitional pass-through payment […]

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Diagnostics FDA MedTech

Clew Medical gains EUA for predictive screening software for COVID-19

Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive […]

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Digital Health FDA Healthcare

FDA warns of cyanide gas risk with media if used with Hologic coronavirus test

Dive Brief: FDA has warned clinical laboratory staff and healthcare providers against using certain transport […]

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Drug-delivery FDA MedTech

Insulet resumes next-gen Omnipod pivotal study following software issues

Insulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management […]

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FDA MedTech Respiratory

NASA, Fitbit gain EUAs for COVID-19 devices

The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa […]

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FDA Funding Patient Monitoring

Bigfoot Biomedical raises $55m in Series C

Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series […]

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Cardiology FDA Surgery

Many heart device trials 'small and fragile,' come with misleading spin: JAMA study

Dive Brief: Clinical trials of invasive cardiovascular interventions are often “relatively small and fragile” and […]

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Cardiology FDA Implantables

FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for […]

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Diagnostics FDA Healthcare

FDA offers reference panel to validate coronavirus tests amid false negative concerns

Dive Brief: FDA has released a reference panel to help commercial and laboratory developers of coronavirus […]

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FDA MedTech Respiratory

Texas-based team seeks EUA for 3D printed emergency ventilator

A team of physicians and engineers developed a hands-free resuscitator bag compression device that can […]

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CE Mark FDA Vascular

Merit Medical lands CE mark for Wrapsody endovascular stent graft

Merit Medical (NSDQ:MMSI) announced that it received CE Mark approval in Europe for its Wrapsody endovascular […]

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FDA MedTech

FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

Dive Brief: FDA will allow companies to make “limited modifications” to medical devices marketed under […]

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Cardiology Digital Health FDA

Eko lands EUA for device that helps detect coronavirus patients with cardiac complications

Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) […]

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Diagnostics FDA Imaging

Philips, startups look to deploy new ultrasound tech amid coronavirus

Dive Brief: Health tech giant Philips and diagnostic imaging startup Caption Health announced FDA clearances […]

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Diagnostics FDA Healthcare

Abbott Receives FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity™ m System

– Alinity m is Abbott’s new molecular lab system, which was approved by the U.S. […]

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Diagnostics FDA Healthcare

BREAKING: BD stops selling COVID-19 antibody test it touted in March

Becton Dickinson (NYSE:BDX) said today that it has stopped selling a point-of-care test touted as being […]

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FDA MedTech Neuro

FDA grants breakthrough designation to a light device for the treatment of Parkinson’s

The Food and Drug Administration recently awarded a breakthrough device designation for a phototherapy device […]

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Biotech FDA

SetPoint Medical Receives IDE Approval for U.S. Pivotal Trial to Study its Bioelectronic Platform in Rheumatoid Arthritis Patients

VALENCIA, Calif., May 06, 2020 (GLOBE NEWSWIRE) — SetPoint Medical, a clinical-stage bioelectronic medicine company […]

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FDA Imaging MedTech

Ambu to launch single-use endoscopy device

Ambu announced today that it will launch its Ambu aView 2 Advance display unit for use […]

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FDA Funding Respiratory

Pulmonx raises $66m to commercialize minimally-invasive emphysema treatment

Pulmonx announced today that it raised $66 million in a financing round led by global life […]

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FDA Orthopedic Spine

Astura Medical gains US FDA clearance for El Capitan ALIF system

Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for […]

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FDA Healthcare MedTech

VentFree Respiratory Muscle Stimulator Gets FDA Emergency OK for COVID-19

Liberate Medical, a company based outside of Louisville, Kentucky, won FDA Emergency Use Authorization for […]

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FDA Neuro Respiratory

Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

Dive Brief: FDA awarded a first-of-its-kind emergency use authorization to a respiratory muscle stimulator device […]

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FDA Respiratory

FDA authorizes NASA-designed ventilator for COVID-19

While NASA took enterprising steps last week toward returning astronauts to the moon by 2024, it also […]

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FDA Imaging Vascular

Vascular Solutions recall of Langston dual lumen catheter is Class I

The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen […]

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FDA MedTech Pediatrics

Medtronic continuous dialysis system designed for small children gets FDA nod

Dive Brief: Medtronic received De Novo authorization from FDA for a device designed to provide […]

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Digital Health FDA Neuro

Pear rolls out digital therapeutic for schizophrenia, after FDA loosens regulations in COVID-19 response

Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited […]

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Cardiology FDA Patient Monitoring

Coala Life launches expanded COVID-19 remote patient monitoring capabilities

Coala Life today said it expanded its monitoring capabilities to monitor COVID-19 patients from home. […]

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FDA Gastroenterology MedTech

FDA says 18 deaths linked to intragastric weight loss balloons

Dive Brief: FDA on Monday sent an update to healthcare providers describing risks associated with […]

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FDA Funding Healthcare

Gottlieb, Slavitt pitch $46.5B plan for COVID-19 contact tracing, isolation

Dive Brief: A slate of high profile former health officials from the Trump and Obama […]

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Digital Health FDA MedTech

Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules

A new FDA policy aiming to boost access to digital health devices for treating psychiatric disorders during […]

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FDA Patient Monitoring

Philips wins EUA for patient monitor

The FDA has granted Royal Philips (NYSE:PHG) an emergency use authorization for one of its IntelliVue bedside […]

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Cardiology FDA Vascular

LivaNova cardiopulmonary devices can be used longer under FDA coronavirus guidance

LivaNova (NSDQ:LIVN) announced that some of its cardiopulmonary products are now permitted for extended use in […]

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FDA MedTech

FDA finalizes post-inspection feedback protocol for medical device makers

Dive Brief: FDA published a final guidance document Tuesday that establishes a standard method for medical […]

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Digital Health FDA Patient Monitoring

FDA OKs digital health tools for use during pandemic

Digital health companies are quickly embracing changes by the Food and Drug Administration that would […]

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Cardiology FDA Healthcare

Yale’s Ventilator Splitter Receives FDA Emergency Use Authorization

Vent Multiplexor LLC announced that it received FDA Emergency Use Authorization for its device that […]

Topic: FDA

FDA eases rules on remote patient monitoring devices during pandemic

FDA eases rules on remote patient monitoring devices during pandemic

GTX Medical wins FDA breakthrough device designation for targeted epidural spinal stimulation

Boston Scientific secures CMS pass-through nod for single-use endoscopes

Clew Medical gains EUA for predictive screening software for COVID-19

FDA warns of cyanide gas risk with media if used with Hologic coronavirus test

Insulet resumes next-gen Omnipod pivotal study following software issues

NASA, Fitbit gain EUAs for COVID-19 devices

Bigfoot Biomedical raises $55m in Series C

Many heart device trials 'small and fragile,' come with misleading spin: JAMA study

FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

FDA offers reference panel to validate coronavirus tests amid false negative concerns

Texas-based team seeks EUA for 3D printed emergency ventilator

Merit Medical lands CE mark for Wrapsody endovascular stent graft

FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

Eko lands EUA for device that helps detect coronavirus patients with cardiac complications

Philips, startups look to deploy new ultrasound tech amid coronavirus

Abbott Receives FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity™ m System

BREAKING: BD stops selling COVID-19 antibody test it touted in March

FDA grants breakthrough designation to a light device for the treatment of Parkinson’s

SetPoint Medical Receives IDE Approval for U.S. Pivotal Trial to Study its Bioelectronic Platform in Rheumatoid Arthritis Patients

Ambu to launch single-use endoscopy device

Pulmonx raises $66m to commercialize minimally-invasive emphysema treatment

Astura Medical gains US FDA clearance for El Capitan ALIF system

VentFree Respiratory Muscle Stimulator Gets FDA Emergency OK for COVID-19

Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

FDA authorizes NASA-designed ventilator for COVID-19

Vascular Solutions recall of Langston dual lumen catheter is Class I

Medtronic continuous dialysis system designed for small children gets FDA nod

Pear rolls out digital therapeutic for schizophrenia, after FDA loosens regulations in COVID-19 response

Coala Life launches expanded COVID-19 remote patient monitoring capabilities

FDA says 18 deaths linked to intragastric weight loss balloons

Gottlieb, Slavitt pitch $46.5B plan for COVID-19 contact tracing, isolation

Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules

Philips wins EUA for patient monitor

LivaNova cardiopulmonary devices can be used longer under FDA coronavirus guidance

FDA finalizes post-inspection feedback protocol for medical device makers

FDA OKs digital health tools for use during pandemic

Yale’s Ventilator Splitter Receives FDA Emergency Use Authorization