Healthcare Press Releases

Hyperfine, Inc. the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—announced the issuance of new MRI standards by the Intersocietal Accreditation Commission (IAC), a leading CMS-approved accrediting body. The new standards, effective immediately, now include portable MR scanning at the point of care.

Novoxel Inc. announces the U.S. FDA clearance of the Tixel i (pronounced "Tixel Eye") for sale in the USA.The newest member of the Tixel family of products was cleared for application of localized heat and pressure for patients with Evaporative Dry Eye due to Meibomian Gland Dysfunction (MGD).

 GT Metabolic™ Solutions, Inc. is pleased to announce the completion of the first magnetic compression anastomosis cases in the U.S. Helmuth Billy, MD, of Ventura Advanced Surgical Associates in Ventura, CA, completed the cases using the MagDI™ System.

In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare announced the U.S. Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring breakthrough AI-powered atrial fibrillation detection. In a medical device first, OMRON's novel machine learning IntelliSense™ AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke1.

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).

Medtronic plc  a global leader in healthcare technology, announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.

Okomera announces Bpifrance funding to develop and standardize novel CRISPR screening assay to accelerate drug discovery in oncology with leading cancer research center of Marseille, CRCM.

HemoSonics, LLC, a medical device company focused on acute bleeding management, announced it has been awarded one of the $525,000 grand prizes in the National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge. NIH's RADx Tech for Maternal Health Challenge sought to accelerate the development of innovative diagnostic tools and solutions to address the maternal mortality crisis.

ZEISS Medical Technology announced the broad U.S. distribution of the MICOR® 700 from ZEISS, reinventing lens extraction with the first hand-held lens removal device with ultrasound-free operation, providing a sustainable solution with a low initial investment to help surgeons broaden their intraocular working space.

Centinel Spine®, LLC the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®),  announced the completion of 7,500 U.S. cases with the prodisc C Vivo and prodisc C SK Cervical TDR System since the limited commercial launch two years ago, in September 2022.