Medical Device

Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution

Biomedical company Femasys has successfully completed the first commercial procedure using its innovative FemaSeed intratubal insemination product. FemaSeed, which has received clearance from the U.S. FDA, employs a novel approach to enhance fertilization by precisely delivering sperm directly to the fallopian tube—the natural site of conception. This method is designed to be a primary therapeutic choice for those seeking pregnancy, offering reduced…

DeepLook Medical’s DL Precise Software Receives Regulatory Approval in the UK

DeepLook Medical has recently achieved a significant milestone by receiving regulatory approval in the United Kingdom for its DL Precise software. DL Precise, an advanced visual enhancement software, distinguishes itself through its ability to uncover hidden data within medical images. Utilizing a sophisticated shape-recognition technique, the software provides clear, segmented, and measured views of target masses, enhancing the speed, accuracy, and consistency…

Fujifilm Healthcare Europe Introduces AMULET SOPHINITY for Enhanced Breast Cancer Diagnosis

Fujifilm Healthcare Europe has introduced the AMULET SOPHINITY digital mammography system at the European Congress of Radiology 2024. The system is designed to offer high-resolution imaging while utilizing low-dose X-ray radiation, aimed at enhancing the accuracy and comfort of breast cancer diagnostics. Breast cancer is the leading cancer among women in Europe, and with cancer diagnoses expected to rise, the need for…

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…