Movano Health has received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. The company states this clearance unlocks potential applications in clinical trials, post-clinical trial management, and remote patient monitoring for healthcare providers and payors. “We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B…
Caldera Medical has announced the acquisition of UVision360, developer of the LUMINELLE hysteroscopy and cystoscopy systems. The deal expands Caldera’s portfolio in minimally invasive solutions for diagnosing and treating conditions such as polyps, fibroids, and intrauterine pathology. “We are excited to integrate LUMINELLE’s technology into Caldera Medical’s growing portfolio,” said Bryon Merade, CEO of Caldera Medical. “This acquisition strengthens our commitment to…
Hologic, a medtech company focused on women’s health, has announced a definitive agreement to acquire Gynesonics, a privately held medical device company. The acquisition is valued at approximately $350 million, subject to working capital and other customary closing adjustments. Gynesonics is known for developing the Sonata System, designed for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including those…
Medtech company INNITIUS has announced promising results from its FineBirth Clinical Trial-1 (FB-CT1) for its novel Fine Birth device, designed to improve the diagnosis of threatened preterm labor (TPTL). Preterm birth, occurring in approximately 500,000 cases annually in the EU alone, is a critical public health issue responsible for over 1 million deaths each year globally. It remains the leading cause of…
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Melodi Health, a medical device company based in Minneapolis, announced two significant milestones last week. The company successfully closed a $10.75 million oversubscribed Series A funding round and launched the “ARIA” investigational device exemption (IDE) trial, designed to improve outcomes for women undergoing breast reconstruction following mastectomy. The funds raised will support ongoing clinical activities and further product development. Melodi Health, founded…
Shanghai-based Yipurun Biotech (YPR) has announced the approval of its Corina Intrauterine Drug-Eluting System (“Corina”) in China. This device is set to advance the treatment of patients with moderate-to-severe intrauterine adhesions (IUA) who undergo transcervical resection of adhesions (TCRA). The approval was granted based on a randomized controlled clinical trial that demonstrated Corina’s superior efficacy compared to the current standard-of-care treatments. Intrauterine…
Cairn Surgical, a medtech company focused on enhancing the precision of breast cancer surgeries, has successfully closed $4.5 million in Series A2 financing led by Morningside Ventures. The newly acquired funds will be directed towards completing the pivotal U.S. trial of Cairn Surgical’s Breast Cancer Locator (BCL™) System, a novel technology designed to significantly enhance the accuracy of breast-conserving surgeries, commonly known…
