Levita Magnetics today announced the international launch of its MARS (magnetic-assisted robotic surgery) system with its placement at Hospital Luis Tisne in Santiago, Chile. Dr. Julio Jimenez used the system to perform same-day-discharge cholecystectomies (gallbladder removal) and bariatric surgeries. Jiminez previously helped Levita Magnetics with its clinical trials, said Levita Magnetics founder, CEO and President […]
FDA warns of thermal issues with Philips DreamStation 2 CPAP machines
The FDA is warning patients and health care providers to watch Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while […]
Henry Schein reports more disruption as cyberattackers take credit
Henry Schein said today that it is working to bring its ecommerce platform back up after more problems related to its cyberattack. The medical device manufacturer and distributor said last week that its ecommerce platform and other applications were unavailable and that “the threat actor from the previously disclosed cyber incident has claimed responsibility.” Today, […]
What’s next for Medtronic’s RDN program after FDA approval?
Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the […]
Another medtech company reports a cybersecurity incident
LivaNova says it’s the latest victim of a cybersecurity incident. The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations. “Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity […]
BD hires new chief medical officer from 3M Health Care
Becton, Dickinson & Co. today named Dr. Ronald “Ron” Silverman as EVP and chief medical officer. He replaces BD Chief Medical Officer Dr. William Sigmund, who announced plans to retire from BD earlier this year. The change takes effect Dec. 4, 2023. Silverman comes from 3M Health Care, where he served as SVP and chief medical […]
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. [Update: Read more of our coverage from the weeks following the approval, including Medtronic’s lessons learned, what’s next for the technology, and other potential applications.] A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic […]
Henry Schein confirms data breach, details financial impact of cyberattack
Henry Schein warned customers and suppliers today that their sensitive information may have been exposed in a cyberattack. The medical device manufacturer and distributor first disclosed the cyber security incident on Oct. 15. Then, this month, a ransomware gang known as BlackCat/ALPHV said they encrypted the company’s systems and stole 35 TB of sensitive data. […]
Cyber gang threatens to release Henry Schein data in ransomware attack
A cyberattack group known as BlackCat is threatening to release Henry Schein data unless the medical device manufacturer and distributor pays a ransom. BlackCat (also known as ALPHV, both named after the ransomware of the same name) said they’ve encrypted Henry Schein’s systems after failed negotiations with Coveware, which describes itself as “ransomware recovery first […]
Inari Medical plans to buy LimFlow Medical for up to $415M
Inari Medical today announced a definitive agreement to purchase LimFlow Medical for up to $415 million. The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI). San Jose, California–based Inari said it expects to complete the acquisition by the end of 2023. […]
Ashley McEvoy’s J&J exit means new leadership for AdvaMed board
Former Johnson & Johnson EVP and Johnson & Johnson MedTech Worldwide Chair Ashley McEvoy will step down as the chair of the Advanced Medical Technology Association (AdvaMed) board of directors. That’s according to an AdvaMed spokesman, who couldn’t yet say when McEvoy would step down or whether anyone has been tapped to serve the rest […]