Medical Device

New Study Confirms Flyte Device’s Efficacy in Stress Urinary Incontinence Treatment

Pelvital, a medtech company specializing in women’s health, has announced the publication of a pivotal study in the peer-reviewed journal Therapeutic Advances in Urology. The study, titled “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women,” validates the efficacy of their FDA-cleared Flyte device. The research indicates significant improvements for women suffering from stress urinary incontinence (SUI) and…

Elidah Secures Series A Funding to Advance Women’s Health Innovations Addressing Urinary Incontinence

Elidah, a healthcare technology company known for developing FDA-cleared non-invasive, wearable treatments for urinary incontinence in women, has recently announced the completion of its Series A funding round. The company has successfully secured an undisclosed amount of investment, led by Blu Venture Investors and supported by contributions from Right Side Capital and Integral Private Wealth Advisors. This financial milestone is set to…

Baymatob Receives MRFF Funding for Oli PPH, an AI-Guided Maternal Health Device

Baymatob, an Australian medtech startup, has been awarded funding from the Medical Research Future Fund (MRFF) as part of the ANDHealth+ digital health commercialisation program. This program supports Australian startups incorporating artificial intelligence (AI) and machine learning in healthcare. Baymatob’s project, Oli PPH, is a notable recipient of this funding. Oli PPH is based on Baymatob’s Oli maternity sensor and diagnostic platform.…

Hologic Receives FDA Clearance for Genius Digital Diagnostics System for Cervical Cancer Screening

Hologic has announced FDA clearance for its Genius Digital Diagnostics System, marking it as the first digital cytology system approved by the FDA that utilizes artificial intelligence (AI) and advanced imaging to enhance cervical cancer screening according to the company. The solution aims to improve the accuracy of detecting pre-cancerous lesions and cervical cancer cells, streamline workflow in laboratories, and elevate patient…

Fertilis’ MicroICSI Is Set to Enhance IVF Outcomes According to New Study

Fertilis, an Australian medtech company, has developed the prototype of an innovative device, microICSI, aimed at refining the IVF process. A recent study published in the Journal of Assisted Reproduction and Genetics study, titled “A micro-fabricated device (microICSI) improves porcine blastocyst development and procedural efficiency for both porcine intracytoplasmic sperm injection and human microinjection,” now underscores the device’s effectiveness in improving embryo…

Matrix Health and Care Secures Patent for Advanced Pelvic Assessment Device

Matrix Health and Care has been granted a patent from the USPTO for Matrix, an innovative self-use pelvic assessment tool aimed at enhancing gynecological examinations. Distinct from traditional speculums, Matrix emphasizes patient comfort and control, allowing for self-administration in clinical settings and integrating real-time data transmission for clinical evaluation and research. The patent marks a significant milestone for Matrix Health & Care…

Gynesonics’ Non-Invasive Uterine Fibroid Treatment Gains Official Recognition with Establishment of New CPT Code

Gynesonics, a medical device company specializing in women’s healthcare, recently announced the creation of a new Category 1 CPT Code for its Sonata Transcervical RF Ablation Procedure, used in the treatment of uterine fibroids. The American Medical Association (AMA), in collaboration with the American College of Obstetrics and Gynecology (ACOG), has assigned code 58580 to this procedure, reflecting its integration into current…

ASPIVIX Receives CE Mark for Carevix, Its Device to Lower IUD Procedural Pain

Aspivix, a company specializing in women’s health technology, has recently received CE Mark approval for its Carevix device, indicating its compliance with European health, safety, and environmental protection standards. This approval allows for the commercial use of Carevix in European countries. Carevix is designed to reduce pain during transcervical procedures, such as the placement of Intrauterine Devices (IUDs). It operates using a…