Dexcom announced today that it launched its latest continuous glucose monitor (CGM) system, the Dexcom ONE+. The San Diego-based company began rolling out the system in Spain, Belgium and Poland. It plans for a launch next week in the Netherlands, too. In some countries, the system replaces the previous-generation Dexcom One sensor. ONE+ uses Dexcom’s […]
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FDA expands approval for Boston Scientific spinal cord stim to include chronic back pain without prior back surgery
Boston Scientific announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems. The indication covers chronic low back and leg pain in people without prior back surgery — called non-surgical back pain (NSBP). Boston Scientific says first-line treatment for people with chronic back pain tends to have limitations. […]
Fast Five: LivaNova picks longtime J&J exec as CEO; 3M could reportedly raise up to $12B from Health Care spinoff
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, February 6, 2024. Fast Five by MassDevice · LivaNova picks longtime J&J exec as CEO; 3M could reportedly raise up to $12B from spinoff Procyrion […]
Philips has a serious BrightView recall due to potential falling component
Philips issued a recall notification deemed Class I — the most serious kind — for its BrightView SPECT imaging systems. In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) […]
Microbot Medical submits surgical robot for FDA IDE
Microbot Medical (Nasdaq:MBOT) announced today that it filed an FDA investigational device exemption (IDE) application for its surgical robot. Braintree, Massachusetts-based Microbot designed the Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on […]
ReWalk Robotics looks to the future following Lifeward rebrand
On Jan. 29, ReWalk Robotics announced a rebrand to “Lifeward.” The rebrand had, in many ways, been in the works for about six months. Really, though, Lifeward CEO Larry Jasinski started formulating this plan a few years ago. All it needed was a few key ingredients to propel the physical rehabilitation and recovery company forward. […]
10 surgical robotics companies you need to know
The surgical robotics space saw a major shakeup last year. “Robotics is hard. Robotics in healthcare is hard.” Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October. It pretty much sums up the situation for medtech companies large and small […]
3M could reportedly raise up to $12 billion from Solventum spinoff
3M stands to make billions of dollars from spinning off its Health Care business into a new company called Solventum, according to a Star Tribune of Minneapolis report. The newspaper’s report cited a Fitch Ratings report, which said the up to $12 billion from the Solventum spinoff would come in over the next five years. […]
Fractyl Health goes the IPO route
Fractyl Health — developer of medtech and gene therapies to reverse diabetes and obesity — began trading on the Nasdaq today under the symbol GUTS. Lexington, Massachusetts–based Fractyl Health priced its 7,333,333 shares of common stock at $15 per share, enabling it to bring in about $110 million from the IPO. The company expected the […]
What’s next for Boston Scientific after Farapulse’s FDA approval?
Chief Medical Officer Dr. Ken Stein explains the plans at Boston Scientific after its landmark pulsed field ablation approval. On Jan. 31, Boston Scientific became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib. The landmark approval came just over a month after Medtronic became the first […]
Edwards wins FDA approval for its Evoque replacement tricuspid valve
Edwards Lifesciences announced today that the FDA granted approval for its Evoque tricuspid valve replacement system. The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first […]