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 […]
Medtech company Masimo announced it had received FDA De Novo clearance for Opioid Halo, the […]
Opioid overdose can be quickly countered by a nasal spray administration of naloxone, a drug […]
Dive Brief: The U.S. Food and Drug Administration has qualified a tool made by NEVA […]
[Image courtesy of the FDA] The FDA is responding to an ever-growing list of […]
Dive Brief: Medtech companies will be able to more easily update devices with an artificial […]
Dive Brief: Surmodics, which is partnering with Abbott to develop a drug-coated balloon treatment for […]
Better Therapeutics (Nasdaq:BTTX) shares ticked up on fourth-quarter results and projections for its flagship product in […]
Synaptive Medical has announced US Food and Drug Administration (FDA) registration of its next-generation robotic […]
When it comes to medicine, catering to convenience and patient preference can have life-changing results. […]
Woven Orthopedic Technologies announced recently that the FDA granted 510(k) clearance for its Ogmend implant enhancement […]
Athersys has announced planned amendments to its MASTERS-2 clinical trial protocol following a Type B […]
Brainomix has today announced that its 360 e-ASPECTS tool for stroke has received US Food […]
Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical […]
Dive Brief: Baxter International issued an urgent medical device correction notice for its Life2000 Ventilation […]
Carthera, which develops the Sonocloud—an ultrasound-based medical device used to treat a wide range of […]
Respiree, a med tech spinoff of Singapore’s Agency for Science, Technology and Research, has obtained […]
Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for […]
The FDA cleared a new gastric calibration tube last week, announcing it as the first authorization of […]
Elekta (Stockholm:EKTA-B) says an FDA 510(k) clearance represents a new era in precision radiation therapy […]
Dive Brief: ReCor Medical has released a pooled analysis of three trials of its ultrasound […]
Stryker (NYSE:SYK) announced today that it received FDA 510(k) clearance for its Q Guidance System with […]
Athersys, the company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced recently that […]
Curiteva has received the 510(k) clearance from the US Food and Drug Administration (FDA) for […]
DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine […]
Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use […]
Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing […]
One challenge of developing a drug for a disease with no approved therapies is that […]
Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation […]
Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful […]
The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from […]
Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with […]
CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy […]
Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation […]
VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral […]
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide […]
Empirical Spine has revealed that it has recently completed the final step in the US […]
Movano Health (Nasdaq:MOVE) announced today that it unveiled its Evie smart ring designed specifically for […]
Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal […]
Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has […]
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