Titan Medical (Nasdaq:TMDI) is suspending a special meeting of shareholders that was supposed to vote on a share consolidation plan. Since announcing the plan for the Jan. 12 meeting, however, the surgical robotics company’s management has decided to instead begin a strategic review. A sale of the company is a possibility. Meanwhile, Titan has also […]
Neuralink reportedly faces probe over animal testing
Elon Musk’s brain-computer interface venture Neuralink faces a U.S. Department of Agriculture Inspector General animal welfare investigation, according to Reuters. Reuters cited sources familiar with the investigation and company operations. The sources said the Agriculture Department opened the probe at a request of a federal prosecutor. The Reuters report described a high-pressure environment at Neuralink […]
FDA tightens indications for Abiomed Impella RP system
The FDA announced today that it is updating the labeling on Abiomed‘s Impella RP system to reflect the final post-approval study results. Abiomed announced in October that FDA had approved the catheter-delivered Impella RP Flex with SmartAssist system. It is Abiomed’s newest system to provide temporary right ventricular support for up to 14 days. People […]
Neuralink to implant its BCI in a person within 6 months
Elon Musk’s brain-computer interface venture Neuralink plans the first in-human implant of its N1 device within the next six months, Musk said during a show-and-tell last night. Neuralink officials later said the company was working with the FDA on an eventual approval and was optimistic about starting its first in-human clinical trial. Viewers got to […]
Olympus launches power morcellator with FDA-advised changes
Olympus today announced the U.S. market launch of its Moresolution power morcellator, saying it supports the safe use of the gynecologic devices under FDA guidance. In 2020, the FDA issued final guidance on power morcellators after the devices faced questions about potentially spreading cancer. The agency recommended limiting laparoscopic power morcellation (LPM) to use with […]
CMR Surgical and J&J are partnering on surgical robotics
CMR Surgical announced today that Johnson & Johnson MedTech’s Ethicon business will work with CMR to sell its Versius surgical robotics systems in select markets. The collaboration involves commercial teams from the two companies working together. They’ll focus on selling to select hospitals in Italy, France, Germany and Brazil. “By entering into this collaboration agreement […]
More deaths reported in Philips respiratory devices recall
The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall. It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the […]
Medtronic reduces guidance amid slower procedures and supply recovery
Medtronic (NYSE:MDT) today reported second-quarter financial results that beat Wall Street expectations on earnings but missed on revenue. On top of the mixed results, the world’s largest medical device company reduced its guidance for the rest of the year. During the earnings call, Medtronic CEO Geoff Martha cited a slower recovery in procedure volumes in […]
Teleflex announces another round of restructuring
Teleflex (NYSE:TFX) plans another round of restructuring — including manufacturing offshoring — to better position itself for long-term growth. In a Form 8-K filed with the SEC today, the Wayne, Pennsylvania–based maker of critical care and surgical products said it expects to incur $31 million to $40 million in restructuring costs through 2023. About $18 […]
Merit Medical announces launch of ‘EZ’ radial compression device
Merit Medical Systems (NASDAQ: MMSI) today announced the U.S. launch of its PreludeSync EZ radial compression device. South Jordan, Utah–based Merit Medical described the PreludeSync EZ as a unique cinch-style wristband. The company designed it to provide precise two-handed placement and clear visibility of the access site. The goal is to optimize bleeding prevention for […]
Philips’ respiratory devices recall has even more problems
The FDA says some Philips ventilators — reworked as part of the company’s massive respiratory device recall — have new problems. The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said last week. Philips followed up today with a news release that said […]