Abbott nabs CMS reimbursement for FreeStyle Libre continuous glucose monitor

Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitor is now available to Medicare patients, after the Centers for Medicare & Medicaid Services determined that the device can be classified as a therapeutic CGM. The FreeStyle Libre is designed to read glucose levels through a sensor worn on the back of a person’s upper […]

Webinar: The top medtech stories of 2017 – Jan. 30

Tuesday, January 30, 2018 2:00pm ET / 11:00 PT     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. MDO’s managing editor Chris Newmarker will

7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>

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FDA clears device that treats diabetic foot ulcers for market

The FDA announced today that it has cleared the Dermapace System diabetic foot ulcer treatment device for market. Dermapace System is the first shockwave device to treat foot ulcers caused by diabetes, according to the device’s creator Sanuwave. “Diabetes is the leading cause of lower limb amputations,” Binita Ashar, director of the division of surgical

Beta Bionics raises $2m

Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. Read the whole […]

European committee backs Novo Nordisk’s once-weekly Type II diabetes therapy

A panel of experts from the European Medicines Agency issued a positive recommendation today for Novo Nordisk‘s (NYSE:NVO) once-weekly diabetes drug, Ozempic. The committee’s recommendation will need to be endorsed by the European Commission before the insulin-maker’s product can be formally marketed in the EU. Get the full story at our sister site, Drug Delivery Business News.

Companion Medical launches smart insulin pen in U.S.

Companion Medical started selling its smart insulin pen in the U.S. today, according to the San Diego, Calif.-based company. The InPen system, which combines an insulin injector pen and a smartphone app, is compatible with Eli Lilly‘s (NYSE:LLY) Humalog and Novo Nordisk‘s (NYSE:NVO) Novolog fast-acting insulin. Get the full story at our sister site, Drug Delivery Business News.

Phillips-Medisize, Dance Biopharm ink deal for inhaled insulin device

Privately-held biotech Dance Biopharm and Phillips-Medisize have entered into a joint development deal for a connected drug-delivery device for inhaled insulin. The agreement gives Phillips-Medisize, which already designs and manufactures devices for Dance, the development work for future enhancements of Dance’s devices, as well as commercial manufacturing of the inhaled insulin delivery device when it gets to the market.

These 10 medtech companies care a lot about research

Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced? Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in

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Artificial organ market worth expected to double in the next 5 years

The artificial organ market is expected to more than double by 2022, according to a market analysis report from Yole Développement in France. The market is expected to be work $1.3B in 2017 and with a consumer annual growth rate (CAGR) of 20%, it is expected to be work $3.5B by 2022. “This impressive growth

Bigfoot Biomedical CEO hits back against CMS over data-sharing decision

Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has […]

How DarioHealth turned the smartphone into a user-friendly glucose monitor

When DarioHealth (NSDQ:DRIO) CEO Erez Raphael looks at the medical device world, he sees solutions that were designed by healthcare professionals and doctors – and this presents a stark contrast with the consumer device industry, he pointed out. “We have seen there are a lot of cases, most of the cases in the industry, where the […]

The top 10 medical disruptors of 2018

Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from

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OptiScan’s glucose monitoring system for the ICU wins 510(k) clearance

OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance. The device is the first-of-its-kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units. Get the full story at our sister site, Drug Delivery Business News.

Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use […]