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MedTech Dive @MedTechDive

We provide business journalism and in-depth insight into the most impactful news and trends shaping medical technology, Sign up here: dive.pub/mtd8

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MedTech Dive@MedTechDive
4 Feb 2022
As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another year of uncertainty. MedTech Dive's three-part series explores key trends for the space in 2022. medtechdive.com/news/medtech…

Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

medtechdive.com
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GE HealthCare raised its revenue and earnings expectations for 2023 as it plans to cut costs. buff.ly/44KSpun
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J&J raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and new product launches in its medtech segment. buff.ly/3K5wkyi
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J&J subsidiary Abiomed's heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, according to a recall notice. buff.ly/46WEgM7
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A clinical trial found that overall, treating hearing loss in older adults had no effect on the rate of cognitive decline over three years. But a smaller analysis showed a big difference in adults who were at increased risk for cognitive decline. buff.ly/3Onr7oh
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Medtronic is recalling nearly 350,000 implantable defibrillators because the devices may deliver a reduced-energy shock, or no shock at all, when therapy is needed, the FDA said Tuesday. buff.ly/3ryAkRw
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Big Health has bought Limbix to add a treatment for adolescent depression to its portfolio of digital therapeutics. buff.ly/3XYJR0q
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ViewRay, a company that makes an MRI-guided radiation therapy system for cancer treatment, filed for Chapter 11 bankruptcy. buff.ly/3DksBJw
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Responding to concerns about the safety of hernia mesh devices, the FDA analyzed the adverse event reports it has received over the past 22 years and reviewed 45 research papers published in the past 11 years. buff.ly/44L5iEk
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QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the FDA. The company received reports that the tests showed lower than expected troponin levels, and advised clinicians to immediately stop using them. buff.ly/44sUz1H
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Becton Dickinson disclosed that it has identified eight cybersecurity vulnerabilities in its Alaris infusion pump system. buff.ly/44M7Gun
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The FDA approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), offering another option to devices made by Teleflex and Boston Scientific. buff.ly/3NY7Ica
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The U.S. International Trade Commission (ITC) has delayed a decision on a patent dispute between Apple and Masimo until October. buff.ly/3DbjVF9
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The FDA has found paclitaxel-coated devices are unlikely to increase the risk of death when used to treat peripheral arterial disease, leading it to work with device-makers to update labeling. buff.ly/3NQvqGT
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Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries. buff.ly/3PSenXG
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Tandem Diabetes Care received FDA clearance for its Mobi insulin pump, a smaller form-factor device that could drive growth for the company next year. buff.ly/44rHUMn
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The European Commission on Wednesday fined gene sequencing pioneer Illumina about €432 million ($480 million), the maximum penalty it could impose, for closing the 2021 acquisition of cancer test developer Grail without first gaining the commission’s approval.
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Researchers and physicians at the University of Pittsburgh and UPMC developed a machine learning model that can identify patients who are at high risk for complications after surgery, according to a study published Friday in JAMA Network Open. buff.ly/43pGwZk
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CMS is set to propose outpatient reimbursement that will increase sales of Shockwave Medical’s heart disease device, Morgan Stanley analysts wrote in a note. buff.ly/3NLfGoD
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Martin Fischer will join Fresenius Medical Care as CFO starting on Oct. 1. Previous CFO Helen Giza was promoted to CEO. buff.ly/3PMsfCV
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The election of two new directors to Masimo’s board last month could set the stage for a sale or spinoff of the medtech company’s Sound United consumer audio division, analysts at Needham said in a report on Monday.
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