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Saved

Topic: Policy & Regulation

article icon article
FDA FDA Approved Ophthalmology Policy & Regulation

Johnson & Johnson Vision leader explains significance of latest IOL milestone

The Vision business at Johnson & Johnson MedTech has hit its latest milestone, earning a significant regulatory […]

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Implantables Neuro Policy & Regulation

Neuracle reportedly wins first BCI approval in China

According to multiple reports, the Chinese medical device regulatory body granted Neuracle the country’s first […]

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Leadership Policy & Regulation

AdvaMed names Melissa Torres as new leader for technology and regulatory affairs

AdvaMed said Melissa Torres is the association’s new executive vice president of technology and regulatory affairs. Torres […]

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Implantables Policy & Regulation Software

Tandem Diabetes Care issues insulin pump warning over potential speaker malfunction

Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated […]

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Drug-delivery Implantables Policy & Regulation

Medtronic MiniMed 780G wins CE mark for type 2 diabetes, young children

Medtronic (NYSE: MDT)+ today picked up CE mark to expand its MiniMed 780G system’s indications. Our sister […]

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FDA Approved Policy & Regulation Respiratory

Synchrony Medical wins FDA nod for airway clearance system

Synchrony Medical announced that it received FDA 510(k) clearance for its LibAirty airway clearance system. […]

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Policy & Regulation Robotics Surgical Robotics

Top surgical robotics companies agree on remote surgery guidelines

Top surgical robotics companies have joined forces to publish technical guidelines for robotic telesurgery. Announced […]

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Catheters FDA Policy & Regulation

Reflow Medical wins FDA de novo clearance for peripheral stent system

Reflow Medical today announced it received FDA de novo clearance for its Spur Peripheral Retrievable Stent […]

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Cardiovasular MedTech Policy & Regulation

Boston Scientific discontinues Acurate TAVR sales, cites regulatory burden

Boston Scientific (NYSE: BSX)+ has discontinued global sales of its Acurate neo2 and Acurate Prime transcatheter aortic […]

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FDA Policy & Regulation Surgical Robotics

SS Innovations to submit SSi Mantra 3 to FDA in July

SS Innovations announced today that it plans to submit a de novo classification request to the […]

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Healthcare Ophthalmology Policy & Regulation

Bausch + Lomb wins CE mark for full range of vision intraocular lens

Bausch + Lomb announced today that it received CE mark approval for its LuxLife full range […]

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FDA Cleared Policy & Regulation Surgical Robotics

FDA clears first stapler for single-port robotics from Intuitive

Intuitive (Nasdaq: ISRG)+ announced today that it received FDA clearance for its fully wristed SP SureForm 45 […]

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FDA Leadership Policy & Regulation

FDA has a new top medical device evaluator

The FDA recently announced it appointed Ross Segan as the new Director of the Office […]

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Diagnostics FDA Cleared Neuro Policy & Regulation

FDA clears EEG for brain analysis from Forest Devices

Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system […]

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FDA Imaging Policy & Regulation

FDA approves enhanced Philips LumiGuide endovascular navigation wire

Philips(NYSE: PHG)+ announced today that it introduced the FDA-approved, 160 cm version of its LumiGuide endovascular […]

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FDA MedTech Policy & Regulation

InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System

Tel Aviv, Israel, and Miami, Florida — September 16, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer […]

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Digital Health FDA Policy & Regulation

Apple wins FDA nod for hearing aid software for certain Airpods

Dive Brief: The Food and Drug Administration said Thursday it authorized a hearing aid feature […]

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FDA Approved Implantables Neuro Pain Management Policy & Regulation

FDA approves electrical nerve stim tech from Neuros Medical

Neuros Medical announced today that it received FDA approval for its Altius direct electrical nerve stimulation […]

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Funding MedTech Policy & Regulation

UFP to buy device component maker AQF Medical, extending deal spree

Dive Brief: UFP Technologies has agreed to buy medtech component manufacturer AQF Medical for 43 million […]

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AI FDA MedTech Policy & Regulation

FDA seeks feedback on predetermined change control plans

Dive Brief: The Food and Drug Administration has released draft guidance on medical device predetermined change […]

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FDA Orthopedic Policy & Regulation Spine

SurGenTec wins FDA nod for bone marrow aspirate kit

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate […]

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FDA Cleared MedTech Policy & Regulation Surgical Robotics

Procept wins FDA clearance for updated prostate surgery robot

Dive Brief: Procept Biorobotics has received 510(k) clearance for an updated version of its surgical […]

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Funding MedTech Oncology Policy & Regulation Surgery

Biden pledges $150M for medical tech to improve cancer surgery

Dive Brief: President Joe Biden and First Lady Jill Biden on Tuesday said $150 million […]

Original post by MassDevice

Written by: Sean Whooley

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