• 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...
  • Zimmer Slapped with $2M Court Order for Flawed Hip

    A growing number of flawed device cases are going to court, according to the lawyer representing a New Mexico man who was just awarded more than $2 million in a product liability case against Zimmer Biomet for a faulty hip implant.Amanda Pedersen Following a two-week bench trial, Zimmer Biomet Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective hip implant. New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely...
  • Should You Take a Second Look at Silicone?

    Silicone's versatility could help address challenges in drug delivery and healthcare.Daphne AllenSilicone is probably one of the “most studied biomaterials in existence,” said James Lambert, director, life sciences R&D, for the NuSil brand of silicone.The Trelyst team of experts taps silicone’s potential to create new delivery systems that make it much easier for patients to get their medication.But despite an extensive body of knowledge that’s flowed from such research, the...
  • Five Years Out, Prostate Procedure Bears Little Repeating

    Data from NeoTract Inc.'s pivotal trial show UroLift reduces symptoms, and is well tolerated.Nancy CrottiNeoTract Inc.'s UroLift system consists of permanent implants designed to retract the lateral lobes of the prostate gland to reduce compression of the urethra. The procedure does not require cutting, heating, or removal of prostate tissue. A device to ease enlarged prostate symptoms has demonstrated durability, safety, and efficacy five years post-treatment.Data from the pivotal LIFT...
  • Will Your EpiPen Work in an Emergency?

    Mylan said its manufacturing partner for EpiPen devices has expanded a recall of the product in the United States and other markets.Amanda PedersenMylan's manufacturing partner for the EpiPen and EpiPen Jr products has recalled 13 lots of the devices due to the potential that they contain a defective part that could cause activation failure. Patients who carry an EpiPen or EpiPen Jr do so with the understanding that if the time comes to use the device, it could potentially save their life...
  • Did a Broken Promise Cost Roche Millions of Dollars?

    Updated on April 3, 2017, with comments from J&B Medical Supply. Two Roche units have accused several pharmacies and medical suppliers of padding their own pockets by exploiting price differences of diabetes test strips sold under two different types of insurance plans.Amanda Pedersen A broken promise over retail sales of Roche diabetes test strips may be at the heart of a federal lawsuit against a handful of pharmacies and medical suppliers. And if Roche is right, that broken...
  • How Nanoparticles Could Help Destroy Tumor Cells

    Updated on April 3, 2017, to include interview comments from the researcher leading this study. Researchers devise a new strategy that involves tethering hundreds of nanoparticles to individual tumor cells to make them more vulnerable to drug treatments.  Kristopher Sturgis A new study out of MIT shows a new approach to cancer treatment that involves coating tumor cells in nanoparticles that can then weaken the cell, making it more susceptible to an attack by drug treatments.The...
  • Breath Biopsy Company Lands Major Insurer’s Investment

    Owlstone Medical will use new funding to commercialize its early-detection technology.Nancy CrottiOwlstone Medical's FAIMS platform is designed to detect disease biomarkers in breath. A British company developing “breath biopsy” technology to detect early-stage cancer has landed an investment from a major insurer.The undisclosed investment from Aviva Ventures brings total funding for Owlstone Medical to $23.5 million. Aviva Ventures is the venture capital arm of London-based Aviva plc, the...
  • Bos Sci Strikes $435M Deal for Swiss TAVR Player

    Boston Scientific's plan to buy Symetis is seen as complementary to the company’s embattled structural heart line.Nancy Crotti Boston Scientific plans to buy a Swiss transcatheter aortic valve replacement (TAVR) company for $435 million in cash. The purchase of Symetis will complement its structural heart offerings with existing products and a promising pipeline, according to Boston Scientific executives.Keep track of who's buying, selling, and spinning off with our free report, Medtech...
  • How to Get Cleveland Clinic Behind Your Medical Device

    Representatives from the venerable Ohio medical center explain what medical device developers need to do to get their products backed by Cleveland Clinic.Jamie HartfordAs business development director for Cleveland Clinic, Tom Sudow speaks at a lot of events, and he says can often read the minds of audiences he addresses. They’re thinking, “If I could just get my idea in front of the Cleveland Clinic, I’d be set for life,” he explained March 29 at the Advanced Design & Manufacturing...
  • How to Think Outside the Checkboxes of Risk Management

    Risk management strategy should be about more than a series of checkboxes on a regulatory form. Consultant Mike Drues encourages his clients to think outside the checkboxes to create a risk management plan that makes sense from an engineering and biology perspective.Amanda Pedersen All medical device companies have some form of risk management plan, but not all risk management plans are created equal.“In my opinion, most all of them do a pretty horrific job at it,” said Mike Drues,...
  • Elon Musk's Next Venture Could Link Your Brain to AI

    Word in the tech world is that Elon Musk, the business visionary in charge of SpaceX and Tesla, is on the verge of launching a new venture aimed at developing an implantable computer-brain interface device. Neuralink Corp. has no official public presence yet, but Musk acknowledged its existence Tuesday on Twitter.Amanda Pedersen The tech world is buzzing this week with news that Elon Musk's newest venture aspires to link artificial intelligence with the human brain, via an implantable chip...
  • Two Canadian Medtech Companies Combine to Boost U.S. Presence

    StarFish Medical and Kangaroo Group complement each other well, according to StarFish’s CEO.Nancy CrottiA fast-growing company in western Canada is buying a smaller company in Toronto to form the country’s largest medtech design and development firm.StarFish Medical of Victoria, BC, expects to complete the purchase of Kangaroo Group on April 3 for an undisclosed sum. StarFish founder and CEO Scott Phillips will lead the combined company, which will retain the StarFish name. Kangaroo CEO...