Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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LivaNova said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications.
The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric population. Previously, the device was only approved for patients ages 12 and older. Read more
Intuitive Surgical is reportedly refusing to sell any more of its da Vinci robot-assisted surgery platforms in Pakistan until the two it’s already got on the market there are brought back on line.
The Sindh Institute of Urology & Transplantation in Karachi asked to acquire a da Vinci system, according to The News of Pakistan, but Intuitive Surgical refused until a pair of disused da Vincis at other hospitals in Karachi are made operable again. Read more
LipoSeuticals said today that it closed a financing round for an undisclosed amount led by Hong Kong-based life sciences fund, Delos Capital.
The company has developed a sugar-lipid polymer-based formulation, Sulocence, which boosts drug stability and solubility. LipoSeuticals said it is applying the drug delivery technology to the reformulation of an array of marketed specialty drugs. Read more
Shareholders revived a purported class-action kickbacks lawsuit against Cardiovascular Systems that was dismissed without prejudice earlier this year, citing in the new complaint a $25 million judgment against the company in a related case.
St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused it of running a kickbacks program by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to a complaint filed by Travis Thams, who worked for CSI as a district sales manager from 2012 to 2013. The Tham lawsuit also accused the company of running an off-label promotion scheme to push sales of its unapproved 4 French catheter. Read more
The year is only half over and it’s already proving to be a busy one for mergers & acquisitions in the medical device space. In just 6 months. MassDevice.com assembled a list of the 10 of the biggest M&A deals in medtech so far – with a combined price tag of over $65 billion (and that’s not even counting the $2 billion Philips acquisition of Spectranetics). Read more