A federal appeals court will not reconsider its rejection of J&J’s complex legal maneuver to shield itself from talc-related liability. The U.S. Court of Appeals for the Third Circuit’s decision on J&J’s “Texas two-step” could set the stage for a U.S. Supreme Court ruling in a case that’s drawn a great deal of attention in […]
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Medtronic reveals more details on surgical business consolidation
Medtronic (NYSE:MDT) today confirmed the consolidation of its Surgical Robotics and Surgical Innovations operating units into a single Surgical operating unit and said it would not close its facilities in Colorado and Connecticut. MassDevice was the first to report the operating unit consolidation and promotion of former Surgical Robotics President Mike Marinaro to lead the […]
Cognito Therapeutics raises $73M for non-invasive neuromod tech
Cognito Therapeutics announced today that it raised $73 million in a Series B financing round to support its neuromodulation technology. Cambridge, Massachusetts–based Cognito Therapeutics develops its neurotechnology to treat central nervous system (CNS) diseases. It designed its non-invasive neuromodulation device to deliver proprietary gamma frequency light and sound stimulation. The investigational device is intended to […]
Study says heart failure survival improves with Abbott CardioMEMS monitoring tech
Hemodynamic pressure sensing with Abbott’s CardioMEMS HF system can significantly reduce the risk of death from heart failure. That’s according to a meta-analysis of three randomized, controlled trials that Abbott presented today at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data comes from an analysis evaluating CardioMEMS HF in heart failure […]
Study backs CVRx Barostim neuromod for patients with heart failure
Data presented today supported the use of the Barostim neuromodulation device from CVRx (Nasdaq:CVRX) in patients with cardiovascular diseases. The BeAT-HF trial evaluated the Barostim extravascular, implantable neuromodulation device. Dr. Michael Zile, professor of cardiology at the Medical University of South Carolina, presented findings at the second annual Technology and Heart Failure (HF) Therapeutics (THT) […]
FDA OKs Inspire therapy for younger Down syndrome patients
Inspire Medical Systems (NYSE:INSP) announced today that the FDA has approved its implantable Inspire therapy for pediatric Down syndrome patients. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear [Boston], led by Dr. Christopher Hartnick, have pioneered the use of Inspire in this important group of people, and we […]
Johnson & Johnson MedTech’s leader is AdvaMed’s new chair
AdvaMed announced today that it has named Ashley McEvoy, EVP of MedTech at Johnson & Johnson, as its new chair. The group’s board of directors unanimously elected McEvoy as its chair during its quarterly meeting yesterday. She is the first woman to serve as chair at the major U.S. medical technology trade association, which was […]
What could medtech lose from the Silicon Valley Bank shutdown?
A host of medtech companies dodged the loss of billions of dollars in Silicon Valley Bank deposits — but the space still faces challenges. That is one of the big takeaways from the latest DeviceTalks Weekly podcast. The FDIC shuttered Silicon Valley Bank on March 10 to stave off a bank run amid depositor concerns […]
Asensus secures pediatric indication for its robotic surgery system
Asensus Surgical announced today that FDA has cleared an expanded pediatric indication for its Senhance robotic surgery system. Research Triangle Park, North Carolina–based Asensus says Senhance is the first and only digital laparoscopic surgery solution for pediatric patients. During the company’s fourth-quarter earnings announcement early this month, it said it expected the pediatric indication this […]
FDA sends warning letter to Olympus over endoscope manufacturing
The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year. According to the letter, the agency conducted an inspection of the Tokyo facility […]
Pear Therapeutics stock sinks as it may look for a sale or merger
Pear Therapeutics (Nasdaq:PEAR) announced today that it engaged in a process to explore strategic alternatives to maximize shareholder value. Shares of PEAR fell more than 30%to 41¢ apeice in midday trading on the back of the news. MassDevice‘s MedTech 100 index, which includes stocks of the world’s largest medical device companies, was up slightly. Boston-based […]