fda Archives - Crunchbase News /tag/fda/ Data-driven reporting on private markets, startups, founders, and investors Thu, 22 Jun 2023 21:14:54 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/cb_news_favicon-150x150.png fda Archives - Crunchbase News /tag/fda/ 32 32 Point Robotics’ Surgical Robot Is Taiwan’s First FDA-Cleared /health-wellness-biotech/health-care-surgery-robot-taiwan-fda/ Wed, 24 Aug 2022 18:48:14 +0000 /?p=85168 just cleared the first surgical robot from a company in Taiwan.

Taiwan-based announced on Tuesday it received FDA clearance for its Kinguide Robotic-Assisted Surgical System, a handheld robot that can be used in orthopedic surgeries.

The system creates 2D and 3D models of the anatomy and pinpoints where there needs to be a drill point. The robot acts like a “hand” for the surgeon to attach different surgical tools to and use for different procedures. It also balances shaky hands and guides the surgeon to make precise drills into the bone and add screws, making the process as minimally invasive as possible.

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Point Robotics’ watershed FDA clearance is a large badge for Taiwan’s small health care and biotech industry. Funding in the space saw a 176.6% increase between 2019 and 2020, according to Crunchbase data, and went to only nine startups.

The next step for Point Robotics is to apply the surgical system to other types of spinal procedures like herniated disc decompression. It will also start pursuing approval in Europe and China.

The 6-year-old company raised $18 million in Series A funding in 2020 from , and through government-assisted funding. In January it raised an undisclosed sum of funding.

The rise of orthopedic surgery

SpineAssist, the first spine robot, received FDA approval in 2004 with its ability to improve accuracy and decrease complications and recovery time. Precision is of utmost necessity in the spine to prevent long-term spinal problems or permanent damage to the spine, which could affect mobility or sensory experience.

However, medical technology in orthopedic surgery is a massive upfront cost for hospitals and clinicians, and requires surgeons to train with the technology.

, an Israel-based company that owns a robotic guidance platform, was acquired by in 2018. , another orthopedic-focused robotics company, was acquired by in 2013 and has expanded its product line to assist in knee and hip surgeries.

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Fresh Off New Funding And FDA Woes, Juul Pushes Into China /venture/fresh-off-new-funding-and-fda-woes-juul-pushes-into-china/ Thu, 12 Sep 2019 18:05:51 +0000 http://news.crunchbase.com/?p=20408 Update: 09/18/19: Days after Juul launched in China, Chinese retailers abruptly took off the products from their websites. Read more on or .

As the FDA and Trump Administration crack down on , a San Francisco vaping company, has expanded into China, according to notices posted on two Chinese e-commerce sites: and .

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Juul has not responded to Crunchbase News inquiries regarding its China launch since Monday. One that the company is spending nearly $100 million on brand building and marketing efforts within the region.

The international expansion comes in the wake of domestic turmoil. On Wednesday, the Trump administration announced that it will ban the sale of most flavored e-cigarettes, according to many sources. The ban, partially inspired after a slew of mysterious deaths from vaping-related illnesses, could affect a company like Juul which sells a variety of pod — the cartridge that goes inside of a vape — flavors, including mango and Crème Brûlée.

Flavored e-cigarettes were banned in San Francisco earlier this year.

India, anticipating a similar expansion effort from Juul, is also looking at a crackdown. New Delhi is drafting a proposal that could make the production of e-cigarettes warrant a “jail term up to three years,” .

Juul’s expansion into China makes sense for several reasons. First, China has the world’s biggest population of smokers – roughly . Second, many manufacturing facilities are located in China. Third, China’s (example, ). This expansion and availability could, and would ideally, fight the problem of fake pods.

Juul’s definitely not the first company taking a swing at the market opportunity for e-cigarettes in China. In fact, , a former Juul chemist that helped create the first product, spun out her own e-cigarette startup as a smoking alternative: MystLabs. Its 20-person team is half based in San Francisco, and half based in Shenzhen, . This in mind, Juul is backed by billions in venture capital funding, so competitors may struggle to beat it due to sheer size.

Earlier this month, Juul raised over $780 million in debt financing.

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