Ancora Heart announced today that it raised $80 million in equity financing for its AccuCinch ventricular restoration system. Santa Clara, Calif.–based Ancora Heart said in a news release that funds raised in the equity round are earmarked for the acceleration of the Corcinch-HF pivotal clinical study of the AccuCinch system for treating symptomatic heart failure […]
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FDA approves Nevro’s Senza system to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. The Redwood City, Calif.-based company’s stock was up nearly 6%, to 152.54 per share, by afternoon trading today. Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation. The company is touting that it […]
Endologix wins FDA breakthrough nod for aneurysm sealing system
Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas). Irvine, Calif.–based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according […]
Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’
As we enter what may be the “new normal,” Dexcom’s CEO bets the company can pave the way in continuous glucose monitoring. Dexcom (NSDQ:DXCM), like any company seeking to innovate, remains in a state of perpetual forward motion. That’s the way chair, president & CEO Kevin Sayer views it, anyway. As the company looks toward the […]
MedTech 100 roundup: Industry shatters all-time best with remarkable rise
The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the […]
Pfizer agrees to pay $345M in EpiPen pricing lawsuit
Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices. Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by […]
FDA clears Dexcom Partner Web APIs
Dexcom (NSDQ:DXCM) announced today that it received FDA clearance for its Dexcom Partner Web application programming interfaces (APIs). The San Diego–based company’s Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices. Get the full story at our sister site, Drug Delivery Business […]
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
7 ways to ensure your medical device product design isn’t biased
Correcting unintentional biases in medical device product design is a big step toward improving equity in medtech. Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, says when looking at bias in medical devices, there’s often a lot of narrative in the media of what it is. However, it’s also important to […]
HeartFlow to go public in $2.8B SPAC merger
HeartFlow today said that it will go public by merging with a SPAC called Longview Acquisition Corp. The merger is valued at $2.4 billion plus an estimated $400 million in cash after closing. The transaction is expected to deliver up to $599 million of gross proceeds to HeartFlow to accelerate the growth of its noninvasive, […]
Imperative Care raises $260M Series D for stroke care tech, acquires Truvic Medical
Imperative Care announced today that it closed a $260 million Series D financing round to support its stroke care technologies. Campbell, Calif.-based Imperative Care had its funding led by D1 Capital Partners, with new investors HealthCor Investments and Innovatus Capital Partners also joining the round. In addition, existing investors Ally Bridge Group, Bain Capital Life […]