Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear’s De Novo request, allowing the company to market reSET® for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first time that the FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease.
Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, announced today that the SoftVue Discover Breast Ultrasound Prospective Case Collection project has launched, enrolling the first patient.
NxThera, Inc., a medical device company pioneering the application of its convective radiofrequency thermal therapy to treat endourological conditions, today announced that new data from the first post-market clinical evaluation of its minimally invasive Rezūm System demonstrated significant, safe and effective urinary symptom relief, improved quality of life and preserved sexual function for men treated for benign prostatic hyperplasia (BPH).
The American Society for Clinical Pathology (ASCP) announces the selection of ArborMetrix as its technology and analytics partner to power the National Pathology Quality Registry (NPQR).
Swift Biosciences, a leading provider of innovative library prep solutions for next-generation sequencing (NGS), today announced the launch of a new single-cell methylation sequencing method based on its Accel-NGS® Adaptase™ technology, an efficient and robust NGS-prep solution for whole-genome bisulfite sequencing at single-cell resolution.
Swift Biosciences, a leading provider of innovative library prep solutions for genomic sequencing, today announced the completion of a Series D funding raise of $12.2 million. The company also announced the addition of two new directors to its board, positioning the company for accelerated growth.
SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced FDA clearance and full U.S. commercial launch of the iFuse-3D™ Implant (“iFuse-3D”), the first-ever 3D-printed titanium implant for use in the SI joint.
-Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, has announced that it has named global research and development expert Bruno Dacquay as its new vice president of engineering.
Strata Oncology, Inc., a precision oncology company, today announced the launch of its 2.0 test, StrataNGS, a custom-designed, 90-gene targeted assay focused on actionable genetic alterations in tumor tissue, including standard of care markers and clinical trial eligibility markers.
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