FDA Archives - Page 12 of 15 - TMG Pulse

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FDA Urology

Olympus-backed Medi-Tate gets FDA nod for prostate device

Dive Brief: FDA has granted De Novo authorization to Medi-Tate’s benign prostatic hyperplasia (BPH) device, the […]

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Digital Health FDA Radiology

Smartphone-based ultrasound VistaScan gets FDA nod

Last week the FDA greenlighted the ultrasound app VistaScan from Emagine Solutions Technology. The new software […]

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Drug-delivery FDA

Insulet pauses automated dosing system trial amid software glitch

Dive Brief: Insulet is pausing the clinical trial it hoped would support commercialization of its […]

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FDA MedTech

Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies

Dive Brief: FDA has identified “several” essential medical device manufacturing facilities in China that are being […]

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FDA MedTech

California's new cybersecurity law sidesteps most medical devices, lawyers say

A new law being implemented by the most populous U.S. state could attract the eyes […]

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FDA MedTech

FDA posts trio of medical device warning letters

Dive Brief: FDA has issued a flurry of warning letters against medical device companies shortly […]

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FDA MedTech

Joint FDA-industry real world evidence center issues research frameworks

Dive Brief: The National Evaluation System for health Technology Coordinating Center (NESTcc) on Wednesday published […]

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FDA MedTech

FDA pilots new 510(k) submission template for device manufacturers

Dive Brief: FDA has begun piloting a template for 510(k) submissions to improve the consistency […]

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FDA Neuro Orthopedic

Abilitech aims to arm people with independence

Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm […]

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Digital Health FDA Sensors

Senseonics Eyes Longer-Term CGM Sensor

Senseonics had all the right ingredients to pull in strong earnings in 2019. The continuous […]

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FDA Oncology Women's Health

FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women

Dive Brief: FDA issued a series of updates Tuesday regarding a women’s health device safety […]

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Cardiology Digital Health FDA

J&J and Apple Begin Enrollment for Heartline Study

In the past few years, Apple has greatly increased its presence in healthcare. The Cupertino, […]

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Digital Health Drug-delivery FDA

Tandem shapes FDA strategy for new insulin pump features

Progress on new pump hardware, a wider age indication for its new insulin dosing algorithm, […]

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FDA Orthopedic

On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging

Class III medical devices must follow the premarket approval (PMA) pathway to reach the market. If […]

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FDA Vascular

FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance

Dive Brief: FDA has revised its position on 510(k) submissions for peripheral vascular atherectomy devices […]

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FDA Vascular

Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter

Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access […]

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FDA Vascular

FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients

Dive Brief: FDA has awarded De Novo marketing authorization to a device meant to help […]

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Cardiology FDA Implantables Structural Heart Vascular

Aria CV wins breakthrough nod for pulmonary arterial hypertension device

Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system […]

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Cardiology FDA Imaging

FDA authorizes use of Caption Health’s AI software to capture heart images via ultrasound

The FDA announced today that it authorized the marketing of Caption Health’s Caption Guidance software for assisting […]

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FDA Women's Health

Invo Bioscience to study extended use of fertility system

Invo Bioscience (OTCQB:IVOB) has received FDA approval to begin a clinical trial of its modified InvoCell […]

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CE Mark Drug-delivery FDA

Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

Tension over stents and balloons that are either coated with or are designed to release paclitaxel […]

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Cardiology FDA Structural Heart

Abbott wins FDA breakthrough nod for ventricular assist system

Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable […]

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Cardiology FDA Wearables

Verily Powers up Position in Wearables with New FDA Nod

There are new developments surrounding Verily Life Science’s prescription-only smartwatch. FDA has granted a new […]

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FDA Orthopedic

FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections

Dive Brief: FDA issued draft guidance Monday on 510(k) submission recommendations for arthroscopy pump tubing […]

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Cardiology FDA Structural Heart

Teleflex wins FDA clearance for Wattson temporary pacing guidewire

Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire […]

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FDA Vascular

Ra Medical Systems wins FDA’s OK to study new uses for Dabra system

Ra Medical Systems (NYSE:RMED) announced today that it won investigational device exemption approval to study use […]

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FDA MedTech

5 medtech trends to track in 2020

The medtech industry entered 2020 celebrating the medical device tax’s permanent repeal, a levy it […]

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AR/VR FDA

Virtual, augmented reality in medicine pique FDA's interest

Dive Brief: FDA announced Thursday it will host a meeting March 5 to discuss virtual […]

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Cardiology FDA

Neovasc Reducer gains FDA PMA review

Neovasc this week said it received FDA premarket approval for its Reducer device. Reducer is […]

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FDA Oncology

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

Dive Brief: The latest flurry of breakthrough device designation announcements positions ArcherDX, Geneoscopy and Phagenesis to […]

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FDA Women's Health

Enrollment has ended in Essure postmarket study, FDA says

Dive Brief: FDA on Friday announced that enrollment in a postmarket study of the discontinued […]

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FDA

FDA guidance on catheters zeros in on testing, coatings

Dive Brief: FDA on Friday released a draft guidance document with recommendations that focus in […]

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Cardiology FDA

Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System

Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease […]

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Drug-delivery FDA

7 medtech advances to improve diabetes treatment

Medtech and pharmaceutical companies have made several important strides over the past year when it […]

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FDA MedTech

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but […]

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Digital Health FDA

US FDA clears NuvoAir's connected spirometer device

Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) […]

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FDA Structural Heart

Does JenaValve’s New Designation Signal the Start of Another Strong Year for TAVR?

JenaValve is showing significant progress in the plan to get its transcatheter aortic valve replacement […]

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AI FDA Imaging

3Derm lands FDA breakthrough device designations for autonomous skin cancer AI

3Derm Systems announced that it won two FDA breakthrough device designations for its 3DermSpot autonomous artificial […]

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Cardiology FDA Structural Heart

Abbott's New Designation Helps Advance its Position in LVAD Market

Abbott Laboratories has won a nod from FDA for a new alternative surgical technique for […]

Topic: FDA

Olympus-backed Medi-Tate gets FDA nod for prostate device

Smartphone-based ultrasound VistaScan gets FDA nod

Insulet pauses automated dosing system trial amid software glitch

Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies

California's new cybersecurity law sidesteps most medical devices, lawyers say

FDA posts trio of medical device warning letters

Joint FDA-industry real world evidence center issues research frameworks

FDA pilots new 510(k) submission template for device manufacturers

Abilitech aims to arm people with independence

Senseonics Eyes Longer-Term CGM Sensor

FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women

J&J and Apple Begin Enrollment for Heartline Study

Tandem shapes FDA strategy for new insulin pump features

On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging

FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance

Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter

FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients

Aria CV wins breakthrough nod for pulmonary arterial hypertension device

FDA authorizes use of Caption Health’s AI software to capture heart images via ultrasound

Invo Bioscience to study extended use of fertility system

Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

Abbott wins FDA breakthrough nod for ventricular assist system

Verily Powers up Position in Wearables with New FDA Nod

FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections

Teleflex wins FDA clearance for Wattson temporary pacing guidewire

Ra Medical Systems wins FDA’s OK to study new uses for Dabra system

5 medtech trends to track in 2020

Virtual, augmented reality in medicine pique FDA's interest

Neovasc Reducer gains FDA PMA review

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

Enrollment has ended in Essure postmarket study, FDA says

FDA guidance on catheters zeros in on testing, coatings

Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System

7 medtech advances to improve diabetes treatment

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

US FDA clears NuvoAir's connected spirometer device

Does JenaValve’s New Designation Signal the Start of Another Strong Year for TAVR?

3Derm lands FDA breakthrough device designations for autonomous skin cancer AI

Abbott's New Designation Helps Advance its Position in LVAD Market