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15
Sep

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.
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29
Aug

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).

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29
Jun

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.
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19
Jun

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.
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23
May

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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