FDA Archives - TMG Pulse

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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. […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

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 […]

article

FDA Oncology Radiology

FDA clears Elekta’s radiation therapy automation

Elekta (Stockholm:EKTA-B) says an FDA 510(k) clearance represents a new era in precision radiation therapy […]

article

Cardiology FDA Nephrology

ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision

Dive Brief: ReCor Medical has released a pooled analysis of three trials of its ultrasound […]

article

FDA Imaging Neuro

FDA clears cranial procedure guidance system from Stryker

Stryker (NYSE:SYK) announced today that it received FDA 510(k) clearance for its Q Guidance System with […]

article

Clinical Trial FDA MedTech

Athersys granted clinical Type B meeting with US FDA to discuss MASTERS-2 trial

Athersys, the company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced recently that […]

article

FDA Implantables

Curiteva announces FDA 510(k) clearance for Inspire 3D porous PEEK HAFUSE cervical interbody system

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

article

FDA Spine Therapeutics

DiscGenics receives FDA RMAT designation for IDCT for degenerative disc disease

DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine […]

article

FDA Urology Women's Health

FDA clears single-use ureteroscope system from Boston Scientific

Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use […]

article

Drug-delivery FDA MedTech

Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR

Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing […]

article

Clinical Trial FDA Genomics

FDA Asks Gene Therapy Biotech to Run Clinical Trial That Might Be Impossible

One challenge of developing a drug for a disease with no approved therapies is that […]

article

FDA Gastroenterology Neuro

Axonics receives US FDA approval for fourth-generation rechargeable sacral neuromodulation system

Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation […]

article

Diabetes FDA Spine

FDA approves Abbott’s spinal cord stimulation system for diabetic peripheral neuropathy

Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful […]

article

Catheters FDA Neuro

CELLO II balloon guide catheter gains US FDA approval for peripheral and neurovascular indications

The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from […]

article

FDA Oncology Start-Up

Aetion, FDA partner on oncology real-world data

Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with […]

article

FDA Nephrology Therapeutics

CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy […]

article

Cardiology FDA Implantables

Abbott wins FDA nod for its Navitor transcatheter aortic valve implant

Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation […]

article

FDA Implantables Spine

FDA clears intervertebral body fusion system from VySpine

VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral […]

article

Drug-delivery FDA MedTech

FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech

Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide […]

article

Clinical Trial FDA Spine

Empirical Spine completes full premarket approval submission to FDA for LimiFlex Dynamic Sagittal Tether

Empirical Spine has revealed that it has recently completed the final step in the US […]

article

FDA Wearables Women's Health

Movano unveils medical-grade smart ring for women’s health

Movano Health (Nasdaq:MOVE) announced today that it unveiled its Evie smart ring designed specifically for […]

article

Clinical Trial FDA Pharmaceutical

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development

Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal […]

article

FDA Patient Monitoring Spine

Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs

Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has […]

Topic: FDA

Masimo receives FDA De Novo clearance for opioid overdose alert system

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

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

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

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

Surmodics receives FDA feedback weeks after layoffs

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

Synaptive announces US and Canadian availability of Modus X

The Power of Patient Preference in Shaping the Drug Delivery Market

FDA clears Woven Orthopedic Technologies surgical screw enhancer

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

Brainomix receives US FDA clearance for flagship stroke AI imaging software

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

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

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

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

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

FDA clears first device authorized under Safer Technologies Program

FDA clears Elekta’s radiation therapy automation

ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision

FDA clears cranial procedure guidance system from Stryker

Athersys granted clinical Type B meeting with US FDA to discuss MASTERS-2 trial

Curiteva announces FDA 510(k) clearance for Inspire 3D porous PEEK HAFUSE cervical interbody system

DiscGenics receives FDA RMAT designation for IDCT for degenerative disc disease

FDA clears single-use ureteroscope system from Boston Scientific

Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR

FDA Asks Gene Therapy Biotech to Run Clinical Trial That Might Be Impossible

Axonics receives US FDA approval for fourth-generation rechargeable sacral neuromodulation system

FDA approves Abbott’s spinal cord stimulation system for diabetic peripheral neuropathy

CELLO II balloon guide catheter gains US FDA approval for peripheral and neurovascular indications

Aetion, FDA partner on oncology real-world data

CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

Abbott wins FDA nod for its Navitor transcatheter aortic valve implant

FDA clears intervertebral body fusion system from VySpine

FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech

Empirical Spine completes full premarket approval submission to FDA for LimiFlex Dynamic Sagittal Tether

Movano unveils medical-grade smart ring for women’s health

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development

Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs