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Topic: FDA

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AI FDA MedTech

FDA Releases Artificial Intelligence/Machine Learning Action Plan

Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software […]

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Cardiology FDA MedTech

FDA breakthrough nods go to Alzheimer’s devices, cardiovascular products

FDA has granted breakthrough status to two medical devices aimed at Alzheimer’s disease patients in […]

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Diagnostics FDA

PerkinElmer Wins EUA to Test Asymptomatic People

PerkinElmer is targeting asymptomatic people in its latest testing offering for COVID-19 testing. The Waltham, […]

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FDA MedTech

Medicare to cover breakthrough devices

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a […]

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AI FDA MedTech

FDA debuts plan for AI-based Software as a Medical Device

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

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Biotech Diagnostics FDA

FDA grants EUA for RapCov rapid COVID-19 antibody test

Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody […]

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AI FDA

FDA debuts plan for AI-based Software as a Medical Device

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

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FDA MedTech

FDA takes ‘STeP’ toward safer devices

The FDA has released final guidance for a new, voluntary review process that would streamline […]

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Digital Health FDA Patient Monitoring

After 2020, telehealth use accelerates from ‘digital PPE’ toward mainstream care

The promise of a digital revolution in healthcare has been described as “just a few […]

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Cardiology FDA Imaging

Genetesis wins FDA breakthrough nod for imaging tech

Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation. Mason, […]

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Cardiology FDA MedTech

ReCor Medical gains FDA breakthrough nod for renal denervation system

ReCor Medical this week announced that its Paradise Ultrasound Renal Denervation System won FDA breakthrough device […]

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FDA Implantables Orthopedic

Ensemble Orthopedics gains FDA clearance for hand implant

Ensemble Orthopedics recently announced said it received FDA 510(k) clearance for its Ensemble CMC Implant. […]

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FDA Funding Neuro

BrainsGate raises $14M

Ischemic stroke treatment developer BrainsGate announced today that it secured a $14 million investment to fund future […]

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Cardiology FDA Implantables

Vectorious’ in-heart microcomputer wins FDA breakthrough nod

Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s […]

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Biotech FDA Pharmaceutical

BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with […]

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FDA MedTech Vascular

Penumbra clot-retrieval system gains new FDA nod

Penumbra (NYSE:PEN) announced today that the FDA has granted expanded clearance for its Indigo aspiration catheter […]

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Drug-delivery FDA MedTech

Lilly and Ypsomed team up on automated insulin delivery

Eli Lilly (NYSE:LLY) and Ypsomed (SWX:YPSN) are teaming up to create an automated insulin delivery […]

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Diagnostics FDA

FDA authorizes first COVID-19 test for self-testing at home

Lucira’s molecular testing kit allows individuals to collect their own nasal sample and insert it […]

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FDA Surgery Vascular

Tissium wins FDA IDE for vascular sealant

Tissium today said it received FDA investigational device exemption for its vascular sealant. The vascular […]

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Drug-delivery FDA MedTech

Baxter wins Canadian clearance for infusion system

Baxter (NYSE:BAX) Canada announced today that it received Health Canada authorization for its Novum IQ infusion […]

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Diagnostics FDA Healthcare

Hologic’s diagnostic sales rocket 375% as COVID-19 demand continues to rise

After seeing its overall revenues slip last quarter, Hologic’s COVID-19 testing sales have continued to […]

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FDA Healthcare MedTech

FDA produces list of ‘essential’ devices, drugs for health, military emergencies

The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that […]

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Biotech Diagnostics FDA

Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study

Dive Brief: Computer vision-focused healthcare company Gauss Surgical on Monday announced its clinical study results for […]

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FDA Implantables Vascular

Neovasc angina device fails to win FDA panel backing, stock tumbles 43%

Dive Brief: An FDA advisory committee was overwhelmingly not convinced of the effectiveness of a […]

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Cardiology FDA Implantables

Neovasc refractory angina treatment faces FDA panel review

Dive Brief: FDA’s circulatory system devices panel Tuesday is examining a premarket approval application for […]

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FDA Funding M&A

Exact Sciences to buy cancer screening rival Thrive for up to $2.15B

Dive Brief: Exact Sciences announced Tuesday it plans to buy fellow liquid biopsy developer Thrive […]

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AI FDA MedTech

FDA, Philips warn of data bias in AI, machine learning devices

Dive Brief: FDA officials and the head of global software standards at Philips have warned […]

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AR/VR FDA Pain Management

Applied VR gains FDA breakthrough device nod

AppliedVR announced that it received FDA breakthrough device designation for its fibromyalgia and lower back […]

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AR/VR FDA Spine

FDA slates VR for lower back pain and fibromyalgia for expedited review

Virtual reality company AppliedVR has landed an FDA Breakthrough Device designation for its technology designed […]

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Cardiology FDA Wearables

Livmor Wins Nod for Wearable to Continuously Monitor Afib

Livmor has won a nod from FDA for a physician-prescribed wearable that continuously monitors for […]

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FDA MedTech Neuro

The Ultimate List of Private Medtech Companies to Watch

From time to time, medtech analysts will call out companies in the private sector that […]

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Cardiology FDA Implantables

Abiomed touts latest Impella trial results

Abiomed (NSDQ:ABMD) today announced interim results of a study that found high-risk patients had better outcomes […]

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FDA Implantables Orthopedic

CartiHeal wins FDA breakthrough designation for Agili-C implant

CartiHeal announced that it received FDA breakthrough device designation for its Agili-C implant for treating […]

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FDA MedTech Neuro

SetPoint Bets Big on Vagus (Nerve) to Treat RA

FDA has awarded SetPoint Medical breakthrough device designation for a bioelectronic technology that stimulates the […]

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FDA MedTech Patient Monitoring

Senseonics Pushes to Extend Eversense CGM’s Use to 180 Days

A new indication could help extend the use of Senseonics’s continuous glucose monitor (CGM) system. […]

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FDA Implantables

FDA finalizes black box warning for breast implants

Dive Brief: FDA on Monday finalized labeling guidance for breast implant manufacturers, including a boxed warning informing […]

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Digital Health FDA MedTech

FDA to launch ‘Digital Center of Excellence’

The FDA announced this week that it will launch a “Digital Health Center of Excellence” […]

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FDA Orthopedic Spine

Spineology system gains FDA de novo status

Spineology this week announced it received an FDA de novo grant for its minimally invasive […]

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FDA MedTech

FDA to clarify role of off-label uses in medical device approvals

The FDA has released proposed regulations to make clear that off-label use of a device […]

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Original post by FDA U.S. Food & Drug Association

Written by: Editor

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