Tag: Food and Drug Administration (FDA)

ProSomnus begins subject enrolment in sleep and snore device trial

Medical DevicesDecember 20, 2022

ProSomnus has enrolled the first participant in its Severe Obstructive Sleep Apnea (SOS) study of ProSomnus EVO...

US FDA approves Abbott’s Eterna spinal cord stimulation system

Medical DevicesDecember 20, 2022

The US Food and Drug Administration (FDA) has granted approval for Abbott’s Eterna spinal cord stimulation (SCS)...

Click secures Breakthrough designation from FDA for CT-132 to treat migraine

Medical DevicesDecember 19, 2022

Click Therapeutics has secured Breakthrough Device Designation for its CT-132 prescription digital therapeutic to treat episodic migraine,...

Virpax Pharmaceuticals Reports on FDA Pre-IND Response for NobrXiol™ (formerly VRP324)

CannabisDecember 14, 2022

BERWYN, Pa.–(BUSINESS WIRE)–Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder,...

MaaT Pharma Presents Compelling Consolidated MaaT013 Clinical Data at the 64th ASH Annual Meeting

FintechDecember 10, 2022

Oral presentation at 64th American Society of Hematology Annual Meeting includes promising results from 81 patients with steroid-resistant, gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) treated...

US FDA approves Dexcom G7 CGM for all types of diabetes

Medical DevicesDecember 9, 2022

The US Food and Drug Administration (FDA) has approved Dexcom’s next-generation Dexcom G7 Continuous Glucose Monitoring (CGM)...

BioGX introduces pixl real-time PCR platform with expanded use

Medical DevicesDecember 9, 2022

Molecular diagnostic solutions provider BioGX has launched its portable pixl qPCR real-time PCR platform Ex-US with an...

HeartBeam and Evolve partner to develop AIMIGo 3D VECG device

Medical DevicesDecember 8, 2022

US-based cardiac technology company HeartBeam has entered a deal with Evolve Manufacturing Technologies to develop the AIMIGo...

CORD Files for Premarket Approval with the U.S. Food and Drug Administration for the SC9 Intraocular Lens for Cataract Surgery

Medical DevicesDecember 7, 2022

SC9 Incorporates 21 Patented Features Designed to Position the Lens for Superior Intermediate Vision ALISO VIEJO, Calif., Dec. 8, 2022 /PRNewswire/ -- CORD, LLC, a...

Activ Surgical’s imaging system receives CE Mark approval

Medical DevicesDecember 7, 2022

Activ Surgical has announced receipt of CE Mark approval for its enhanced imaging system, ActivSight Intelligent Light....

The New Marijuana Research Bill Is Another Sign That Federal Prohibition Is Ending

CannabisDecember 7, 2022

On Friday, December 2, 2022, the White House announced that President Biden signed House Resolution 8454, into law:H.R. 8454, the “Medical Marijuana and Cannabidiol Research Expansion Act,”...