BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality […]
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FDA clears self-driving mobile C-arm from Siemens Healthineers
Siemens Healthineers announced today that the FDA granted clearance for its Ciartic Move mobile C-arm with self-driving capabilities. Ciartic Move accelerates and standardizes 2D fluoroscopic and 3D cone-beam computed technology (CT) imaging. Working in hospitals and outpatient facilities, it enables consistent automated workflows and reduced imaging time. Siemens Healthineers designed the system to address the […]
Neuralink says patient used brain chip to play chess online
Elon Musk’s Neuralink brain-computer interface (BCI) venture showed the early results from the first patient to receive its brain chip implant. A nine-minute livestream demonstration on Musk’s “X” social media platform (formerly known as Twitter) showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online. Arbaugh, a quadriplegic, said he […]
Stryker completes acquisition of SERF SAS
Stryker announced today that it completed its previously announced acquisition of joint replacement company SERF SAS. In December, the Kalamazoo, Michigan-based orthopedic giant struck a deal to buy the France-based company from Menix. SERF SAS develops, manufactures and sells a range of large joint replacement products on an international basis. This includes inventing the original […]
Intuitive Ion wins regulatory approval in China
Intuitive Surgical has received approval from regulatory authorities in China to market its Ion surgical robot system. BTIG analyst Ryan Zimmerman said today that the National Medical Products Administration in China approved the system. This occurred through Intuitive’s partnership with Shanghai Fosun Pharmaceutical, a venture established in 2016. The major regulatory nod in China follows […]
Ultrahuman brings in $35M to support wearable health monitoring tech
Ultrahuman announced today that it raised $35 million in an equity and debt investment round. Blume Ventures, Steadview Capital, Nexus Venture Partners, Alpha Wave and Zomato founder Deepinder Goyal participated in the round. Ultrahuman plans to use the funds to build toward further manufacturing capacity and deeper research in the health tracking space. Ultrahuman develops […]
Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year
Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system. The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe. According to a […]
Bio-Rad names Roop Lakkaraju as CFO
Bio-Rad today announced it appointed Roop K. Lakkaraju as EVP and chief financial officer, effective April 15. Lakkaraju joins the clinical diagnostics and imaging systems company from Benchmark Electronics where he served as EVP and chief financial officer and was responsible for all finance-related functions since 2018. “We are pleased to welcome Roop Lakkaraju as […]
LivaNova reports positive study results for neuromod for sleep apnea
LivaNova today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea. The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint. London-based LivaNova’s OSPREY […]
Fujifilm wins FDA nod for AI-powered endoscopy tech that could rival Medtronic’s GI Genius
Fujifilm announced today that the FDA granted 510(k) clearance for its CAD Eye AI-powered detection system for endoscopic imaging. CAD Eye enables the real-time detection of colonic mucosal lesions like polyps and adenomas during colonoscopy procedures. It supports endoscopists in detecting and removing pre-cancerous lesions, regardless of size, shape and color. The system enters a […]
Insulet picks new CFO following McMillan’s move to 3M spinoff
Insulet announced today that it appointed Ana Maria Chadwick as its new EVP, CFO and treasurer. Chadwick’s appointment — which goes into effect on April 22, 2024 — follows an extensive search process conducted by Insulet. That search spanned nearly six months after former CFO Wayde McMillan left for 3M’s Solventum healthcare spinoff in October. […]