Medical Devices
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Jacob Bell
FDA Breakthrough Devices Program nears 300 designations
The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.
By Susan Kelly • May 27, 2020 -
Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared
The Jefferies tracker suggests volume expectations for players in the transcatheter aortic valve replacement market, such as Edwards Lifesciences and Medtronic, may prove a bit conservative.
By Nick Paul Taylor • May 27, 2020 -
Adobe Stock
Medtechs eye key role of ASCs in return of elective care
Elective procedures were increasingly moving from hospitals to lower-cost ambulatory surgery centers prior to COVID-19. Now, ASCs may have a new advantage as a setting where patients feel safer returning to care.
By Maria Rachal • May 26, 2020 -
Nasdaq
Inari Medical launches IPO, shares take off
The maker of mechanical thrombectomy devices sees a $3.6 billion annual U.S. market opportunity. It had the best first-day performance of 74 initial public offerings launched so far this year, Bloomberg calculated.
By Susan Kelly • May 26, 2020 -
ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay
The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.
By Greg Slabodkin • May 26, 2020 -
Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4
Despite the negative impacts of COVID-19 on revenue in the latest quarter, the medtech giant has its strongest balance sheet in years and is looking for acquisition opportunities in the pandemic landscape.
By Maria Rachal , Greg Slabodkin • May 22, 2020 -
Jacob Bell
FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions
Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.
By Nick Paul Taylor • May 22, 2020 -
Getty Images
April was dismal for US hospitals, with long road ahead, surveys find
Operating margins plummeted 174% last month compared to April 2019 and were down 118% from March of this year as surgeries, ER visits and outpatient appointments declined drastically during the COVID-19 pandemic.
By Shannon Muchmore • May 21, 2020 -
Medtronic's revenue dropped 26% in Q4 as coronavirus hit broadly
New CEO Geoff Martha told investors Thursday nearly all sides of the business were negatively impacted by the pandemic's effects.
By Greg Slabodkin • May 21, 2020 -
Hospitals push FEMA to form broad supply pact with medtech
The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.
By Nick Paul Taylor • UPDATED: May 26, 2020 at 7:20 a.m. -
AdvaMed, health systems set ground rules for return of sales reps
Hospitals, nurses and the medtech industry issued guidance to pave the way for device company representatives to re-enter healthcare facilities.
By Susan Kelly • May 20, 2020 -
COVID-19 drives EC to change rules on notified body designations
The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.
By Nick Paul Taylor • May 20, 2020 -
Investors bet diabetes tech immune to full brunt of COVID-19
Pure play diabetes device makers aren't clear yet on how economic uncertainty and the transition to telemedicine may affect new patient demand, but are outperforming the stock market by a long shot.
By Maria Rachal • May 19, 2020 -
Edwards secures CE mark for Pascal tricuspid valve repair device
European approval for the device comes about a month after rival Abbott gained a CE mark for a tricuspid version of MitraClip. Edwards sees tricuspid and mitral valve treatments as a $3 billion market opportunity by 2024.
By Susan Kelly • May 19, 2020 -
Knee replacements nearly halted as hospitals braced for COVID-19, new data show
Even service lines covering often life-threatening conditions saw large drops, with cardiac care falling 57% and cancer care down 37% versus March and April last year, according to analysis by Strata Decision Technology.
By Shannon Muchmore • May 19, 2020 -
Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves
A decade of data on the Melody valve found it more effective in adults than in pediatric patients. In a separate study, the in-development Harmony valve designed to treat severe pulmonary regurgitation met its primary endpoints.
By Susan Kelly • May 18, 2020 -
Allergan's breast implant postmarket studies 'unacceptable,' FDA warns
Within the last 14 months, every manufacturer of the controversial devices allowed for sale in the U.S. has received a warning letter from the agency.
By Maria Rachal • May 15, 2020 -
Getty Images
FDA aims to thwart infusion pump shortage with new industrywide emergency use authorization
The agency is responding to insufficient availability of the lifesaving machines and accessories for COVID-19 patients.
By Greg Slabodkin • May 15, 2020 -
Cardiology group ranks best devices for aorto-iliac arterial interventions
The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.
By Nick Paul Taylor • May 15, 2020 -
Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys
Some analysts say industry predictions on timing of a rebound in elective procedures may be too rosy.
By Maria Rachal • May 14, 2020 -
Courtesy of Caption Health, PRNewswire
Philips, startups look to deploy new ultrasound tech amid coronavirus
The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.
By Nick Paul Taylor • May 14, 2020 -
EC outlines clinical trial safety reporting between MDR, Eudamed start dates
Even with the recent delay to the date of application of the Medical Device Regulation, there will still be at least a 12-month period when the key Eudamed database is not fully available.
By Nick Paul Taylor • May 14, 2020 -
U.S. House of Representatives
House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package
The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.
By Susan Kelly • UPDATED: May 18, 2020 at 10:38 a.m. -
Getty Images
FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks
The potential for a detached catheter tip to damage blood vessels and cause serious injuries or death underpinned the agency’s Class I label for an Applied Medical recall on Tuesday, seven months after the company initiated the recall.
By Nick Paul Taylor • May 13, 2020 -
Abiomed faces familiar reimbursement fluctuation in CMS proposal
An almost 25% reduction to a key heart implant procedure payment code, plus backing for three breakthrough-designated devices, are among the policies outlined in a Medicare proposed rule released Monday afternoon.
By Maria Rachal • May 12, 2020
