Some of medtech's biggest manufacturers faced hang-ups in getting products to market during the second quarter.
FDA's scrutiny of whether devices like breast implants, surgical mesh and paclitaxel-coated balloons and stents were safe enough to remain on the market left some companies in limbo, as did the lingering impact of the shutdown of a key device sterilization facility. President Trump's threats to raise tariffs on China and Mexico — some realized, others not — were also an ongoing worry.
But there were also a number of positive developments for industry, like CMS expanding coverage for TAVR procedures and FDA proposing a regulatory framework for increasingly common artificial intelligence algorithm changes to software as a medical device products.
Below, MedTech Dive revisits some of the most important events from the past few months.
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Sterilization plant shutdown disrupts device supply
Boston Scientific, Medtronic and Smiths Medical are among the manufacturers that reported product shortages and negative impacts on revenue in the months following the February closure of a major ethylene oxide device sterilization plant.
Trade group AdvaMed has lobbied to avoid a tighter Environmental Protection Agency crackdown on emissions of the toxic, but useful, chemical gas, which could further restrict sterilization options for device makers. Read More »
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FDA examines safety of paclitaxel devices after mortality analysis dents sales
The agency convened a panel of experts in June to take a closer look at long-term data provided by manufacturers of paclitaxel-coated balloons and stents, in response to evidence the devices may lead to higher mortality in patients with peripheral arterial disease.
A final, post-meeting statement from FDA remains outstanding, but panelists recommended updating the devices' labels rather than restricting their availability. BD, Medtronic and Boston Scientific hope regulators will tell healthcare providers the benefits of the devices outweigh their risks, after they said uncertainty surrounding the entire class of devices hurt first quarter sales. Read More »
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CMS updates TAVR coverage decision
Under the revised policy, it will be easier for healthcare providers to initiate transcatheter aortic valve replacement procedures receiving reimbursement, and higher procedure volumes will be necessary to maintain that status. The long-awaited final changes drew praise from major U.S. TAVR players Medtronic and Edwards Lifesciences. Read More »
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3M leads single-deal M&A spend with $6.7 billion wound care buy
Amid falling sales in its electronics and energy unit, Minnesota conglomerate 3M bet big on its healthcare business in May with a $6.7 billion deal to buy wound care product manufacturer Acelity. 3M CEO Mike Roman said the largest medtech industry acquisition of 2019 (so far) "supports our growth strategy to offer comprehensive advanced and surgical wound care solutions." Read More »
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LabCorp and Quest patient information compromised in vendor data breach
While hospitals and even some personal medical devices have drawn increased attention for their cybersecurity vulnerabilities, the clinical lab sector fell victim to a scare of its own with Quest Diagnostics disclosing June 3 that 11.9 million patients' data may have been exposed during a system breach reported by one of its vendors, the American Medical Collection Agency.
The next day, clinical lab rival LabCorp said it too was affected, with personal and financial information for 7.7 million patients potentially compromised. Read More »
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More deaths tied to duodenoscope infections
FDA alerted healthcare providers in April that an agency analysis of medical device reports received between Oct. 15, 2018 and March 31, 2019 found three reports of death, 45 reports of patient infection and 159 reports of device contamination linked to inadequate reprocessing.
At least one key senator has added pressure to FDA's warning that manufacturers Olympus, Fujifilm and Pentax have not stuck to timelines for postmarket studies. Boston Scientific and Cook Medical are among the companies aiming to seize the moment and gain marketing authorization for single-use duodenoscopes. Read More »
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European notified bodies step away from medtech ahead of new regulations
The month of June saw at least two notified bodies exit medtech. Lloyd's Register Quality Assurance said it will not offer medical device or in vitro diagnostic services under the new European regulations.
QS Zürich also decided to close its medical device department, leaving Switzerland with one notified body for medical devices and none for in-vitro diagnostics. Read More »
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FDA ends Alternative Summary Reporting program
The agency disclosed it granted 108 reporting exemptions to manufacturers between 1997 and 2019, allowing makers of breast implants and surgical staplers, for example, to forgo submitting individual medical device reports for a product.
When FDA moved to upload previously hidden data files and formally shut down the program this spring, 13 manufacturers of devices including dental implants, implantable cardiac defibrillators and pacemaker electrodes still had active exemptions in place. Read More »
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Medical equipment makers face uncertain tariff policy
Despite dodging the U.S.'s threatened (and scratched) tariffs on Mexico, device makers are still contending with the ramp up of tariffs between the U.S. and China.
President Trump dropped, or at least delayed, plans to impose tariffs on another $300 billion in Chinese goods. The policy would have added to the pinch from the U.S.'s 25% tax on $200 billion in Chinese goods — not to mention China's retaliatory tariffs — affecting products like surgical gloves, imaging equipment and medical lamps. Read More »
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FDA's device center chief tells MedTech Dive safety and innovation are 'two sides of the same coin'
Amid growing scrutiny of the 510(k) pathway, longtime Center for Devices and Radiological Health director Jeff Shuren said in a wide-ranging interview with MedTech Dive a major challenge for the agency is fighting the perception that speeding new devices to market comes at the cost of patient safety, or vice versa. Read More »