Medical Devices: Page 116
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Courtesy of Cleveland Clinic
App-connected pacemakers, telehealth among Cleveland Clinic top 2021 innovations
Medtronic's MyCareLink Heart pacemaker smartphone app is one example of the four medtech developments making the annual top 10 list of medical breakthroughs.
By Nick Paul Taylor • Oct. 7, 2020 -
Medical Alley, GI docs push to ease CMS device pass-through payments
The trade group for Medtronic, Boston Scientific and other medtech giants wants to bar Medicare contractors from making regional coverage decisions that obstruct transitional pass-through payments.
By Susan Kelly , Maria Rachal • Oct. 6, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
CMS officials elaborate on proposed breakthrough device coverage pathway
Agency representatives fleshed out details of proposed reimbursement meant to speed coverage of these technologies in a townhall webcast during AdvaMed's Virtual MedTech Conference.
By Susan Kelly • Oct. 6, 2020 -
M&A on horizon as deep-pocketed medtechs eye distressed assets: EY
The combination of smaller companies questioning their pandemic survival and larger companies with considerable capital may spark a buying surge, the consultancy said in its annual medtech report.
By Nick Paul Taylor • Oct. 6, 2020 -
AdvaMed sends CMS reform wishlist to boost digital health device coverage
The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.
By Nick Paul Taylor • Oct. 2, 2020 -
Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets
The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.
By Nick Paul Taylor • Oct. 2, 2020 -
Ethylene oxide sterilizer rule pushed back by EPA
FDA held a related advisory panel late last year, where one member said the shutdown of device sterilization plants put the U.S. "on the cusp of a major medical logistical failure." COVID-19 has shifted the landscape.
By Maria Rachal • Oct. 1, 2020 -
Adeline Kon/MedTech Dive
Deep Dive5 ways COVID-19 is reshaping the medtech industry
Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.
By Maria Rachal , Greg Slabodkin • Oct. 1, 2020 -
Medtronic hit with DOJ ventilator antitrust probe
The investigation comes amid allegations that industry consolidation contributed to a shortage of the breathing devices during the early months of the COVID-19 pandemic.
By Greg Slabodkin • Oct. 1, 2020 -
AtriCure stock recovers after short seller predicts 'complete collapse' of business
Shares in the atrial fibrillation medtech were down 14% immediately following a scathing report. Analysts at SVB Leerink rebutted the grim assessment from Kerrisdale Capital.
By Nick Paul Taylor • Oct. 1, 2020 -
FDA flags risk of infection with CardioQuip heater-cooler device
The alert comes after three patients were infected with mycobacteria. All such devices on the U.S. market have now been implicated in contamination, including those made by LivaNova, Cincinnati Sub-Zero, Maquet and Terumo.
By Nick Paul Taylor • Updated Oct. 1, 2020 -
Permission granted by Medtronic
Medtronic to expand dialysis access position with Avenu Medical buyout
The deal is the second tuck-in acquisition this year for the medtech's peripheral vascular business and the company's sixth overall, following additions to insulin delivery, surgery and spinal cord stimulation offerings.
By Maria Rachal • Updated Sept. 30, 2020 -
Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting
Slow implementation of UDI and NEST are among the hangups prompting JAMA Internal Medicine authors to envision a better U.S. system for tracking and identifying adverse events, including more mandatory reporting.
By Nick Paul Taylor • Sept. 30, 2020 -
COVID-19 spurred a medtech M&A boom this summer. Will it last?
Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear.
By Nick Paul Taylor • Sept. 30, 2020 -
Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra
The U.K.-based medtech will gain control of a portfolio of shoulder replacement products and other devices that generated revenues of $90 million last year.
By Nick Paul Taylor • Sept. 29, 2020 -
Jacob Bell/MedTech Dive
FDA finalizes black box warning for breast implants
The term "breast implant illness," which one industry group decried as not used in clinical practice, appears multiple times throughout the agency's document but not in its example boxed warning.
By Susan Kelly • Updated Sept. 29, 2020 -
Courtesy of Abbott
Abbott gets CE mark for latest CGM with Dexcom still in the wings
The step is the latest in the rivalry between the two big players in the continuous glucose monitoring market, which Wall Street analysts contend leaves room for both to gain.
By Maria Rachal • Sept. 28, 2020 -
BD to pay $60M to settle Bard pelvic mesh deceptive marketing claims
The payout is a fraction of the at least $475 million Johnson & Johnson has been ordered to pay states over the past year and a half for similar product liability cases.
By Maria Rachal • Sept. 25, 2020 -
FDA finalizes overhauled guidance on device conformity testing pilot
The revised outline of the program, which will allow accredited labs to carry out premarket testing of medical devices, includes an expanded explanation of what the pilot means for device manufacturers.
By Nick Paul Taylor • Sept. 25, 2020 -
Medtronic-Axonics sacral neuromod patent battle heats up
The Patent Trial and Appeal Board is moving forward on reviews requested by the bladder and bowel dysfunction-focused device maker taking on the medtech giant.
By Maria Rachal • Updated Sept. 24, 2020 -
Patient sentiment improving on elective procedures despite ongoing pandemic, survey suggests
A Needham & Company poll from this month found the time older U.S. consumers want to wait before feeling comfortable having surgeries again is shrinking compared to its August results.
By Maria Rachal • Sept. 23, 2020 -
Medtronic gets FDA breakthrough tag for device to prevent infections
The medtech giant has identified Tyrx as among the product lines to benefit from COVID-19.
By Nick Paul Taylor • Sept. 22, 2020 -
FDA De Novo OKs outpace 2019 with Spineology device, two others
A flurry of first-of-their-kind marketing authorizations comes as the agency may be receiving fewer new submissions compared to previous years, according to a MDUFA quarterly report.
By Susan Kelly • Sept. 22, 2020 -
Kendall Davis/MedTech Dive
Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook
The analysts would "like to see the number of procedures stabilize, if not improve" before reconsidering predictions for the medical devices industry.
By Ron Shinkman • Sept. 21, 2020 -
CMS to push back radiation oncology model after industry blowback
Agency administrator Seema Verma said a six-month delay will be formalized via upcoming rulemaking because "more time is needed to prepare."
By Susan Kelly • Updated Oct. 22, 2020
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