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Top Medtech News of 2018

From the launch of a rapid point-of-care flu test to layoffs and warning letters, these were the most popular news stories on MD+DI in 2018.

  • From the launch of a rapid point-of-care flu test to layoffs and warning letters, these were the most popular news stories on MD+DI in 2018.

  • Abbott launched a point-of-care flu test that, according to the company, offers the fastest-ever time to influenza A and B test results. Formerly called Alere i, the ID Now test provides results in 13 minutes or less, with positive results available in about five minutes.

    Norman Moore, Abbott’s director of scientific affairs for infectious diseases, said such a rapid result could help fight antimicrobial resistance.

    “Point-of-care testing enables clinicians to make more confident and informed treatment decisions during a single patient visit. Within minutes of administering a flu test, clinicians will know whether someone is infected with the flu virus or whether more tests are needed,” he told MD+DI. “Point-of-care testing is helping take the guesswork out of diagnosis and treatment. With an accurate diagnosis, clinicians know whether a person is suffering with a virus and that antibiotics won’t do any good. The [fewer] unnecessary antibiotic prescriptions, the less overall resistance we will be fighting.”

    Click here to read the full story.

  • Reports of massive layoffs at IBM Watson Health triggered widespread concern in May, but a company spokesperson told MD+DI that only a "small number" of the company's Watson Health employees were let go.

    "IBM is continuing to reposition our team to align with our focus on the high-value segments of the IT market. We continue to hire aggressively in critical new areas that deliver value for our clients and IBM," Edward Barbini, vice president of corporate communications at IBM said at the time.

    However, Barbini declined to answer questions related to the specific number of layoffs in Watson Health, or the significant percentages that have been reported by multiple news outlets over the past several days.

    "We're not discussing specific numbers. It's a small percentage of our global Watson Health workforce, as we move to more technology-intensive offerings, simplified processes, and automation to drive speed," he said.

    Online commenters on TheLayoff.com and Watching IBM, along with multiple news reports citing unnamed sources from within the organization painted a different picture of the situation. One Dallas-based commenter on TheLayoff.com said that "we all knew it was coming but nobody expected it to be this fast and rampant," while another commenter estimated that 80% of that same Dallas-based office was let go.

    Click here to read the full story.

  • BioSig Technologies caught our readers' attention this year after filing for FDA clearance for its Pure EP system, a surface electrocardiogram and intracardiac multichannel device. If cleared, BioSig would compete in the $4.6 billion electrophysiology market.

    The Pure EP System is designed to cut through the background noise of the lab and its equipment during cardiac recordings, enabling physicians to target and neutralize the areas of the heart that are causing atrial fibrillation, and ventricular tachycardia. More accurate targeting of the offending tissue may reduce the number of repeat catheter ablation procedures, which can last up to eight hours.

    Click here to read the full story.

  • While Zimmer Biomet does appear to be making progress toward resolving its quality control problems, the company received a FDA warning letter in August stemming from an April inspection of the Warsaw North campus.

    The company's quality control problems first cropped up in December 2016 when FDA sent the company a rather long Form 483.  The agency re-inspected the facility in April and made some additional observations, but Zimmer Biomet pushed back on some of those findings. 

    "During the 2018 FDA inspection, Zimmer Biomet personnel and the FDA investigators disagreed on some technical [corrective action] topics, (or Zimmer Biomet did not provide sufficient context or explanation), as evidenced by some of the FDA-483 observations," Jeff Gensler, vice president of quality assurance and quality control at Zimmer Biomet, wrote in the company's 98-page response to FDA.

    Click here to read the full story.

  • Intuitive Surgical launched its first da Vinci system nearly 20 years ago, and yet, in many ways, the field of robotic-assisted surgery is still in its infancy.

    "There's no university program on robotic-assisted surgery today," said Sal Brogna, an executive vice president and the chief operating officer at Intuitive. "We're at the early stages of creating a whole new technology sector. I assume someday you'll go to universities and they'll have robotic-assisted surgery courses, but we're creating it now."

    In September, MD+DI explored the current state of robotic-assisted surgery and what to expect from future surgical robots. Click here to read the full story.

     

  • Another company that landed in hot water with FDA this year is Baxter. The company received a warning letter in connection with the agency's inspection of facilities Baxter acquired when it bought Claris Injectables.

    Baxter added Claris to the pharmaceuticals side of its business in 2017 and the $625 million deal is expected to provide a foundational growth platform for the company. The agency began an inspection of the Claris facilities the day the deal closed, July 27, 2017, which resulted in a Form-483 noting several observations. Baxter responded to the 483 on Aug. 25 and said in a regulatory filing with the Securities and Exchange Commission that it has already implemented corrective actions to many of the issues FDA raised in the July 5 warning letter.

    Click here to read the full story.

  • Stryker made headlines in September when it announced its intention to acquire Invuity for about $190 million. Invuity is known for its Intelligent Photonics devices used to evenly light surgical cavities. Placed at the site of surgery, the illuminators provide cool lighting that allows surgeons to see into dark surgical cavities.

    The handheld lighting devices are primarily used in breast, orthopedic, and spine procedures, but the company expanded into gynecology in 2016. Additional applications include procedures for general surgery, electrophysiology, spine, and orthopedics.

    Click here to read the full story.

  • Boston Scientific found itself on the defensive in May after CBS aired a 60 Minutes report raising concern over its transvaginal mesh products. The report accused Boston Scientific of buying counterfeit materials from a Chinese supplier to make the mesh devices. But the company opened up to MD+DI to tell its side of the story.

    Click here to read what Boston Scientific had to say regarding the 60 Minutes report.

  • Abbott Laboratories had another stellar year in terms of new product launches and strong growth drivers across the company. In fact, the company's pipeline may be the strongest its ever been, thanks to products like the FreeStyle Libre glucose monitoring system, the MitraClip, the HeartMate3, and the Alinity family of diagnostic products – just to name a few.

    "It's interesting, I've never in my career here seen such breadth across the company in new products, new product launches, market conditions, et cetera," CEO Miles White said during Abbott's third-quarter earnings call. "I think the sustainability of the growth and the diversity of it is a huge plus. It's not like we're reliant on a single product or a single country. We're not highly indexed in China, and we're not over-dependent on a single product. There's just great diversity of growth opportunity across the board."

    But like any multinational company, Abbott faces a currency headwind.

    "The little elephant in the room is just, clearly, exchange," White said. "I think all of us, all investors, all companies doing business in international markets, are experiencing the upturn in exchange now, and frankly, a bit of uncertainty about how long it lasts."

    At the beginning of each year, companies like Abbott have a notion of what the currency exchange is going to do, but whichever way that exchange is swinging, it never lasts the entire year, White said.

    Click here to read the full story.

  • In February, Edwards Lifesciences received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis at high risk of open-heart surgery. The Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation.

    Click here to read the full story.

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