Insulet (Nasdaq: PODD) saw its revenue increase 23% year-over-year to $488 million in the second quarter, which ended June 30. That’s according to preliminary Q2 revenue numbers that Insulet released today. The result beats the consensus of Wall Street analysts, who expected that Insulet had $460.27 million in revenue in Q2. The maker of Omnipod […]
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Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott (NYSE: ABT) has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable. The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more […]
ICU Medical’s Smiths Medical has a major syringe pump recall
The FDA this week said it’s designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency’s most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, […]
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 […]
FDA clears VVT Medical varicose veins treatment device
VVT Medical announced in recent months that FDA has cleared its ScleroSafe platform, which delivers endovenous chemical ablation to treat superficial varicose veins. Kfar Saba, Israel–based VVT Medical says it specifically created ScleroSafe to provide efficient, non-thermal, non-tumescent treatment and management of varicosities in superficial veins. Its inverse-action dual syringe injects the ECA substance into […]
Bayer is making a big digital health play
Bayer announced that it has launched a business unit that will focus on precision digital health products across a range of everyday health categories. Bayer will prioritize developing digital solutions that enable people to make more informed health choices based on personal insights and novel delivery mechanisms, the company said in a news release posted yesterday. A […]
Tandem reports positive research for its artificial pancreas tech
Tandem Diabetes Care (Nasdaq:TNDM) today announced a positive meta-analysis of three randomized controlled trials of its Control-IQ advanced hybrid closed-loop technology. The research found immediate and sustained improvements for a diverse range of subjects using Control-IQ technology, according to the research published in the journal Diabetes Technology & Therapeutics. There was an average increase in […]
Boston Scientific hit with $42M verdict in drug-eluting stents IP case
Boston Scientific (NYSE:BSX) must pay $42 million in unpaid royalties to TissueGen and the University of Texas, a federal jury in Delaware has ruled. The jury verdict yesterday came after the finding that Boston Scientific’s Synergy BP drug-eluting stents infringed on TissueGen and the university’s IP. The patent under question arose out of research that […]
FDA says Insulet Omnipod Dash batteries recall is Class I
The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Eli Lilly to start rollout of Tempo personalized diabetes management platform
Eli Lilly and Co. (NYSE: LLY) recently announced it will soon roll out its Tempo personalized diabetes management platform in the U.S. The pharma giant described Tempo as its first connected platform. It includes three components: the Tempo Smart Button, a compatible TempSmart app, and the prefilled Tempo Pen insulin pen. The goal is personalized […]
