| |MARCH 20248Virtual Incision, a company in the cultivate (MD) portfolio, has received marketing authorization from the US FDA for the MIRA Surgical System (MIRA). This is a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device worldwide to be approved for adult colectomy procedures.R. Sean Churchill, MD, MBA, Managing Director of Cultivation (MD), expressed his enthusiasm for the US FDA's approval. He said, "Cultivate (MD) Capital Funds is proud to have partnered with Virtual Incision Corporation on their developmental journey. We have long recognized the need for mainstream robotics in medicine that can simultaneously provide minimally invasive surgery with system portability, allowing use in large university-based hospital systems and smaller community hospitals, all cost-effectively and efficiently. Virtual Incision Corporation accomplished these goals and has redefined the future of robotic surgery."Virtual Incision sees MIRA's innovative design as a potential game-changer in the surgical technology realm. With its compact size (weighing less than two pounds) and user-friendly tray-to-table setup, MIRA aims to enhance operating room efficiency. This approach intends to facilitate the integration of robotic surgery in a wider range of healthcare settings and potentially overcome the logistical challenges associated with the large surgical robots currently available."We have been in awe of watching this incredible innovative technology and team for years, creating and thinking outside of the box," said David Blue, Director of cultivate (MD) Capital Funds. "These miniature robots will be the future and continue to amaze the rest of the surgical robotics world. It will be fun seeing them lead us into this new world! We are so excited and honored to be on this journey with Virtual Incision!"Virtual Incision aims to initiate MIRA's commercial rollout in select centers in the United States with the US FDA authorization in hand.MIRA's broader commercialization and expansion of its roadmap for future indications includes gynecology, general surgery, urology, and other soft tissue and solid organ surgery.Moreover, a new version of the technology tailored to general surgery is in the design phase and expected to be used in a first-in-human study outside the US later this year.POCommissioner Abhimanyu Kale of the Maharashtra Food and Drug Administration (FDA) led a raid on Mumbai-based Raj Products' premises to tackle illicit activities in the cosmetics industry. The operation, in collaboration with enforcement authorities, aimed to crack down on unauthorized cosmetic manufacturing units.Speaking on the raid, the Maharashtra FDA Commissioner emphasized the agency's unwavering commitment to regulatory compliance and public safety. He further stated, "The FDA remains steadfast in its mission to curb illicit practices in the pharmaceutical and cosmetic industries. We will continue to uphold regulatory standards and conduct such crackdowns to maintain the integrity of the market and ensure the safety of consumers."Based on confidential information, the raid uncovered that Raj Products, owned by Anand Patel, was manufacturing cosmetics without the required licenses.Specifically, the company produced "Prince Enriched Coconut Hair oil" by blending coconut oil and light liquid paraffin, which were packaged in pre-printed High-Density Polyethylene (HDPE) containers.Light liquid paraffin treats itchy, irritating, dry skin problems such as eczema and dermatitis. It is also effective in treating rough skin and nutrient deficiencies. Light liquid paraffin oil is used as a food additive, thickener, and stabilizer in dough and batter. It also keeps odors at bay in perfumes, flavors, and soaps.HDPE is a versatile thermoplastic polymer made from petroleum. It is used in various applications, including plastic bottles, milk jugs, shampoo bottles, bleach bottles, cutting boards, and piping.This violation of the Drugs and Cosmetics (D&C) Act 1940 prompted swift action from the FDA. The Drugs Inspector, Greater Mumbai, P B Aswar, seized raw materials, finished products, empty containers, and machinery used in the manufacturing process, amounting to a total worth of more than Rs. 8.88 lakhs.Joint Commissioner (Vigilance) FDA, Rahul Khade, and Assistant Commissioner (HQ-IB) FDA, U.G. Bagmare, provided active guidance throughout the operation, emphasizing the collaborative effort of the enforcement agencies. POVIRTUAL INCISION'S ROBOTIC SURGERY DEVICE FDA APPROVEDMAHARASHTRA FDA TARGETS UNAUTHORIZED COSMETICS UNITS IN MUMBAITOP STORIES
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