Medical Devices: Page 109
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J&J US device unit returns to growth, potential bellwether for medtech Q3 earnings
A double-digit rise in interventional sales was offset by ongoing headwinds in parts of the orthopaedic and surgery franchises.
By Nick Paul Taylor • Oct. 13, 2020 -
De Novo-winning devices often lack effectiveness data, analysis shows
A JAMA Internal Medicine analysis of 63 devices reviewed via FDA's premarket pathway for novel technologies found one-fifth weren't evaluated in pivotal studies.
By Nick Paul Taylor • Oct. 13, 2020 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
TCT 2020: Abbott devices, TAVR systems headline late breaker lineup
The five-day Transcatheter Cardiovascular Therapeutics event kicked off Wednesday.
By Susan Kelly • Oct. 12, 2020 -
Cancer testing drives 2020 medtech IPO surge after slow start
A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.
By Nick Paul Taylor • Oct. 12, 2020 -
Courtesy of AdvaMed
5 key exec insights from 2020's MedTech Conference
Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.
By Maria Rachal • Oct. 9, 2020 -
Fresenius sees COVID-19 driving dialysis device growth, eyes home care strategy
Execs at the company, which upped production of machines by 230% in response to the crisis, laid out plans at an investor day Thursday.
By Nick Paul Taylor • Oct. 9, 2020 -
Medtronic shares early data TAVR works in low-risk bicuspid patients
Authors of the short Medtronic-sponsored trial, published in JAMA Cardiology, suggest the valve may be free of problems that caused early studies of the device in bicuspid disease to report worse in-hospital outcomes.
By Nick Paul Taylor • Oct. 8, 2020 -
Avail raises $100M to let medtech reps remotely oversee surgeries
The Series B funding comes weeks after Smith & Nephew claimed to be the first orthopaedics company to use the telemedicine service.
By Nick Paul Taylor • Oct. 8, 2020 -
Steris inks $850M deal for Key Surgical adds to medtech M&A wave
CEO Walter Rosebrough gave a nod to current low interest rates but said Steris had been looking at this potential transaction "for years, not months."
By Susan Kelly • Oct. 7, 2020 -
'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says
Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.
By Greg Slabodkin • Oct. 7, 2020 -
Analysts predict Zimmer Biomet M&A in 2021 to speed growth
The medtech is likely to initially target private orthopaedic companies worth up to $300 million, Needham analysts specified. The spine and dental businesses, meanwhile, could be on the chopping block.
By Nick Paul Taylor • Oct. 7, 2020 -
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 -
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 -
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 -
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
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