• Will Abbott Be Able to Fix-and-Flip Alere?

    Abbott CEO Miles White sees Alere as “a fixer-upper,” and said the company will divest some parts of the business after the amended deal closes.Amanda Pedersen Abbott CEO Miles White isn’t one to tiptoe around the elephant in the room. So, when it came time for questions during the company’s first-quarter earnings call Wednesday, White was ready to talk about Alere.“Look, the company had some challenges, we all know that, and it’s a bit of a fixer-upper,” he said.Learn about the latest...
  • How Abbott is 'All Over Everything' in FDA Warning

    Abbott CEO Miles White told investors that the company is "all over everything" in its recent FDA warning letter, and that the company will be looking at all of its manufacturing plants, not just the Sylmar, CA-based facility addressed in the letter.Amanda Pedersen Abbott Laboratories smashed first-quarter sales and profit expectations after acquiring St. Jude Medical in early January, but the company’s strong financial performance was overshadowed Wednesday by questions related to a...
  • The Latest on J&J’s Device Strategy

    Johnson & Johnson executives offer insights into their view for the company’s medical device business, which is undergoing a transformation.Marie ThibaultJohnson & Johnson’s latest medical device transactions pale in size compared to the company’s $30 billion deal to pick up Actelion and its 2012 $20 billion acquisition of Synthes. Is there any potential for Johnson & Johnson to go after a large device acquisition?The healthcare giant has announced a few medical device acquisitions...
  • Will Medtronic Deal Ease Cardinal's Deflation Pains?

    Cardinal Health’s $6.1 billion deal for three Medtronic businesses is everything the company hoped it would be, but the stock plunged anyway based on lowered earnings guidance.Amanda Pedersen  Cardinal Health Inc. has had eyes on certain parts of Medtronic’s patient monitoring and recovery division since before the assets were even owned by Medtronic. Now, Cardinal is betting good money – $6.1 billion, in fact – that an acquisition of Medtronic’s patient care, deep vein thrombosis,...
  • Baxter Under Criminal Investigation for Possible Price Fixing

    A Baxter employee has received a grand jury subpoena in connection with a criminal investigation into the company's IV saline business.Amanda Pedersen  Baxter Inc.’s shares slipped Monday, the first trading day after the company disclosed Friday in an SEC filing that one of its employees has been subpoenaed in connection with a Department of Justice criminal investigation into the company’s IV saline business.Don't miss BIOMEDevice Boston, May 3-4, 2017.In February, Baxter reported...
  • Abbott Has More Trouble to 'Absorb' with Bioabsorbable Stent

    Abbott said it will monitor bioabsorbable stent implantations in Europe, following a high rate of heart attacks in European Absorb GT1 patients, plus a separate FDA safety alert regarding adverse events associated with the device.Nancy CrottiA high rate of heart attacks in European patients following implantation of its Absorb GT1 bioabsorbable drug-eluting stent has prompted Abbott Laboratories to begin monitoring surgeons’ implantation techniques.Learn about the latest design strategies and...
  • Abbott and Alere Mend Fences – and Merger

    After a year of fighting and lawsuits, Abbott Laboratories and Alere Inc. have agreed to make up and tie the knot after all – in a new deal worth about $5.3 billion.Amanda Pedersen  Breaking up is hard to do, especially when a multi-billion contract is at stake.Perhaps that realization is what ultimately motivated Abbott Laboratories and Alere Inc. to finding some common ground, and reconciling a merger agreement that is now valued at $5.3 billion, down from the original price of $5.8...
  • Will Abbott Have to Pay for St. Jude’s Mistakes?

    Abbott is in hot water with FDA over St. Jude Medical’s past mistakes, including what was either a lie of omission – or worse.Amanda Pedersen  At best, St. Jude Medical management pussyfooted around the truth back in 2014 during the handling of an ICD battery problem that eventually resulted in a major recall last year. At worst, company leaders didn’t just omit the truth – they lied.In a detailed FDA warning letter to Abbott this week, the agency faulted the company for its handling...
  • FDA Takes Abbott to Task for ‘Hazardous Situation’

    FDA is taking Abbott Laboratories to task for essentially downplaying manufacturing flaws and cybersecurity concerns related to devices acquired through its $25 billion purchase of St. Jude Medical.Amanda Pedersen  It seems Abbott Laboratories acquired more than it might have bargained for when it paid $25 billion for St. Jude Medical earlier this year. The company also inherited a slew of poorly-handled manufacturing problems at the company's Sylmar, CA facility.Learn about risk...
  • Glaukos Eyes Early Promise in New IOP Sensor

    Glaukos Corp., known for developing innovative new technologies designed to treat glaucoma, has acquired a new early-stage sensor technology from DOSE Medical, dubbed the intraocular pressure sensor system.  Kristopher Sturgis Glaukos Corp. continues to establish itself as a leader in the glaucoma technology space. This week the company acquired DOSE Medical Corporation’s intraocular pressure (IOP) sensor system — a new wireless system designed to transform glaucoma therapy through...
  • Electric Field Treatment May Boost Pancreatic Cancer Survival Rates

    A European study of Novocure's tumor-treating fields technology yielded encouraging results for patients with a deadly cancer.Nancy Crotti  A recent small study of low-intensity, alternating electric fields in treating pancreatic cancer suggests longer survival times.Novocure (St. Helier, Jersey) recently completed a feasibility, safety, and preliminary efficacy pilot study of its tumor-treating fields (TTFields) technology in 40 patients with advanced pancreatic cancer. Half of the...
  • A New Solution for Packaging Two Catheters Emerges

    Two catheters or guidewires can be combined on one card, saving material and space.Daphne AllenAn award-winning solution for packaging catheters in flexible formats has just been adapted to hold two catheters and/or guidewires. The Dual Hoop Catheter DISK (Dispenser Integrated System Kit) by CleanCut Technologies features a clipless catheter and guidewire dispenser bonded to a HDPE backer card. Adapted from the company’s original DISK design, which won a Medical Device Excellence Award in 2014...
  • Jury Hits SurgiQuest with a $12.2 Million Verdict

    A jury has found SurgiQuest, a subsidiary of Conmed Corp., liable for a total of $12.2 million in damages related to false advertising claims. Conmed said it will try to appeal the verdict.  Amanda Pedersen False advertising is a costly offense – just ask SurgiQuest Inc.A jury has found the Milford, CT-based subsidiary of Conmed Corp., liable for a total of $12.2 million in damages ($10 million in punitive damages, and $2.2 million in compensatory damages) related to the false...
  • Medtronic Has a Potentially Deadly Shunt Problem

    Medtronic has pulled all unused units of the StrataMR valves and shunts from the market after logging an increase in product complaints, including one reported patient death.Qmed Staff Report Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall of all unused units of the StrataMR adjustable valves and shunts.Learn more about development and design strategies at MD&M East, June 13-15, 2017, in New York.Roughly 2,622 of the affected...
  • Medtech Startups are Killing it on the Funding Circuit

    Several early-stage medtech firms across a range of therapeutic areas have reported financing rounds in the past week, which could be a good sign for the industry. Amanda Pedersen  Pittsburgh-based ALung Technologies Inc. is the latest of several medtech companies to announce a new financing round. ALung closed a $36 million series C financing, including existing convertible notes.ALung's round was led by Philips and UPMC, through its innovation and commercialization arm, UPMC...
  • Are you the master of your data?

    Enterprise labeling systems can help medical device manufacturers manage data in some surprising ways. Enterprise labeling software solutions have been helping medical device manufacturers manage label design, printing, and more for years. But in today’s data-rich environment thanks to Unique Device Identification, pharma serialization, and wearable devices, are such systems delivering all the necessary functionality and cybersecurity? Qmed asked Ardi Batmanghelidj, President and CEO of...
  • J&J's Codman Neuro is Still Wheeling and Dealing

    Johnson & Johnson's Codman Neuro, the business Integra Lifesciences is gearing up to buy for $1.05 billion, scooped up Irish stroke therapy company Neuravi Limited. Amanda PedersenNeuravi Limited developed the EmboTrap clot-retreival device to restore blood flow to the brain. Neuravi launched the device in Europe in 2015 and said at that time it was getting ready to start a U.S. pivotal trial and anticipated FDA approval in 2017. Integra Lifesciences raised some eyebrows earlier...
  • A Match Made in Big Data Heaven?

    By marrying artificial intelligence with big data, two firms are improving patient access to cancer trials.Nancy Crotti A San Francisco artificial intelligence startup and a precision-medicine diagnostics company are teaming up to match cancer patients with clinical trials.The matching process will be based not only on patients’ biomarkers and genomic data, but also on all of the unstructured data in their medical history and files. The AI company, Mendel Health, can upload all of that...
  • Are Medtronic and Cardinal Health Close to a Deal?

     Medtronic may be close to selling its medical supplies business to Cardinal Health for $6 billion, although neither company has confirmed yet that a deal is in the works.Amanda Pedersen Medtronic may be close to cutting a $6 billion deal with Cardinal Health for its medical supplies unit, according to multiple news sources. Although the divestiture has not yet been confirmed by either company, the latest news adds to rumors in February that Medtronic was preparing to sell the medical...
  • Data Restore Faith in Medtronic's HVAD for Destination Therapy

    Medtronic’s HVAD left ventricular assist device, which it inherited last year through its $1.1 billion HeartWare acquisition, showed promising results in terms of death and disabling stroke at 12 months, but missed the primary endpoint that included all neurological events, in the ENDURANCE Supplemental trial.Amanda PedersenMedtronic has submitted data from the ENDURANCE Supplemental trial to FDA to support a destination therapy indication for the HVAD left ventricular assist device. Two...