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Saved

Topic: FDA

article icon article
FDA Healthcare MedTech

ICU Medical Plum Pump Replacement Batteries Hit with Class I Recall

ICU Medical has issued an Urgent Medical Device Correction identifying that replacement batteries for its […]

article icon article
FDA MedTech Pharmaceutical

FDA approves another nasal spray for treating opioid overdose

The FDA approved Opvee nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdoses […]

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Cardiology FDA Implantables

FDA approves next-gen MicroPort CRM pacemakers

MicroPort CRM announced today that it received FDA approval for its Alizea and Celea implantable pacemakers. […]

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FDA Gastroenterology Robotics

Virtual Incision submits surgical robot for FDA de novo review

Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo […]

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Cardiology FDA MedTech

HeartBeam submits AIMIGo vector ECG for FDA 510(k) clearance

HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) application to the FDA for its AIMIGo […]

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FDA Healthcare MedTech

FDA’s mandatory medical device shortage reporting ends

  Reporting of medical device shortages to the FDA is no longer mandatory with last […]

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FDA Imaging Spine

Abbott announces expanded MRI labelling for Eterna spinal cord stimulation system

Abbott has announced that the US Food and Drug Administration (FDA) has approved expanded magnetic […]

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Clinical Trial FDA MedTech

FDA’s Landmark Guidance on Decentralized Clinical Trials (DCTs) Signals a New Era of Patient-Centered Research

The FDA’s new draft guidance on Decentralized Clinical Trials (DCTs) is a landmark moment for […]

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FDA Patient Monitoring Pediatrics

Sibel Health receives FDA 510(k) for pediatric vital sign monitoring tool

Sibel Health, a spin-out of Northwestern University, announced it received a new FDA 510(k) clearance […]

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FDA Robotics Surgery

Vicarious Gives Regulatory Update on Surgical Robot

Vicarious Surgical is on track to bring the submission of its surgical robotic system to […]

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FDA Patient Monitoring Wearables

Samsung gets FDA clearance for irregular heart notification feature, catching up with Apple and Fitbit

Dive Brief: Samsung has received clearance from the U.S. Food and Drug Administration for an […]

article icon article
AI FDA Healthcare

FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech

Dive Brief: The head of the Food and Drug Administration has warned the U.S. needs […]

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FDA MedTech Neuro

Cognixion wins FDA breakthrough designation for BCI for assistive communication

Cognixion announced today that it received FDA breakthrough device designation for its flagship brain-computer interface […]

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FDA Funding Neuro

Feinstein Institutes awarded US$3.4 million to study rTMS therapy in schizophrenia

Researchers at the Feinstein Institutes for Medical Research (Manhasset, USA) have received a US$3.4 million grant from Wellcome to […]

article icon article
AI FDA IDE

Ultromics receives Breakthrough Device Designation for AI cardiac amyloidosis tool and more digital health briefs

UK-based Ultromics announced it received FDA Breakthrough Device Designation for an AI tool that aims […]

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FDA Healthcare MedTech

FDA moving ahead with rule-making on lab developed tests without waiting for Congress: BioWorld

Dive Brief: Dive Insight: Lawmakers have been trying to pass LDT legislation for years. An […]

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FDA Neuro Spine

Biotronik announces US FDA approval of Prospera spinal cord stimulation system

Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord […]

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Catheters FDA MedTech

Biocoat Takes Bold Steps in Coating Market with Hydak UV Technology

Biocoat Inc. is making some substantial noise in the coating market. The Horsham, PA-based company […]

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FDA Funding Neuro

Neuromod Devices closes $33.2M financing for tinnitus-treating neuromodulation tech

Neuromod Devices announced today that it closed a $33.2 million (€30 million) financing round to support […]

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Biotech FDA MedTech

Nelson Labs receives ASCA accreditation from FDA

NEWS RELEASE: Nelson Labs Receives ASCA (Accreditation Scheme for Conformity Assessment) Accreditation from the U.S. […]

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FDA Orthopedic Surgery

FDA clears patient-specific resection for the Restor3d Axiom total ankle

Restor3d received FDA 510(k) clearance for its Axiom patient-specific resection (PSR) system for use with […]

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FDA MedTech Patient Monitoring

Masimo receives FDA De Novo clearance for opioid overdose alert system

Medtech company Masimo announced it had received FDA De Novo clearance for Opioid Halo, the […]

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FDA MedTech Therapeutics

Regulatory Roundup: Narcan’s Nod, an ALS Adcomm, FDA Holds Lifted & More

Opioid overdose can be quickly countered by a nasal spray administration of naloxone, a drug […]

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FDA Implantables Orthopedic

FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners

Dive Brief: The U.S. Food and Drug Administration has qualified a tool made by NEVA […]

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AI FDA MedTech

FDA seeks feedback on pre-determined change control plans for AI/ML devices

  [Image courtesy of the FDA] The FDA is responding to an ever-growing list of […]

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AI FDA MedTech

FDA drafts guidance to ease path to updates for AI-enabled devices

Dive Brief: Medtech companies will be able to more easily update devices with an artificial […]

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FDA MedTech

Surmodics receives FDA feedback weeks after layoffs

Dive Brief: Surmodics, which is partnering with Abbott to develop a drug-coated balloon treatment for […]

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Diabetes Digital Health FDA

Better Therapeutics hopes FDA nod for diabetes digital therapeutic comes in 2023

Better Therapeutics (Nasdaq:BTTX) shares ticked up on fourth-quarter results and projections for its flagship product in […]

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FDA Robotics Spine

Synaptive announces US and Canadian availability of Modus X

Synaptive Medical has announced US Food and Drug Administration (FDA) registration of its next-generation robotic […]

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Drug-delivery FDA

The Power of Patient Preference in Shaping the Drug Delivery Market

When it comes to medicine, catering to convenience and patient preference can have life-changing results. […]

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FDA Implantables Orthopedic

FDA clears Woven Orthopedic Technologies surgical screw enhancer

Woven Orthopedic Technologies announced recently that the FDA granted 510(k) clearance for its Ogmend implant enhancement […]

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Clinical Trial FDA Neuro

Athersys announces changes to MASTERS-2 trial endpoints following US FDA meeting

Athersys has announced planned amendments to its MASTERS-2 clinical trial protocol following a Type B […]

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AI FDA Neuro

Brainomix receives US FDA clearance for flagship stroke AI imaging software

Brainomix has today announced that its 360 e-ASPECTS tool for stroke has received US Food […]

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Clinical Study FDA IDE

Vivasure wins FDA IDE approval, receives €30M from Haemonetics

Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical […]

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FDA Respiratory

Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation

Dive Brief: Baxter International issued an urgent medical device correction notice for its Life2000 Ventilation […]

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Clinical Trial FDA MedTech

Carthera and US FDA align on key aspects of potential pivotal trial assessing Sonocloud system

Carthera, which develops the Sonocloud—an ultrasound-based medical device used to treat a wide range of […]

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Cardiology FDA MedTech

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor

Respiree, a med tech spinoff of Singapore’s Agency for Science, Technology and Research, has obtained […]

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FDA MedTech Neuro

Lenire non-invasive neuromod for tinnitus wins FDA de novo nod

Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for […]

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FDA FDA STeP Gastroenterology

FDA clears first device authorized under Safer Technologies Program

The FDA cleared a new gastric calibration tube last week, announcing it as the first authorization of […]

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Original post by Medical Device + Diagnostic Industry

Written by: Katie Hobbins

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