FDA ups premarket application user fees by 2.5% for FY 2022

The base PMA fee will be $329,000, though the increase is far less than the 7% hike instituted last year.

By Greg Slabodkin • Aug. 2, 2021

Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 2, 2021

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Medical 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

Hillrom reverses course, will finalize $375M BardyDx acquisition

The decision ends a months-long fight by Hillrom to back out of the buy due to substantially reduced Medicare rate cuts for long-term cardiac monitoring. Hillrom expects the deal to close in the coming weeks.

By Ricky Zipp • Aug. 2, 2021

Pent-up demand drives Edwards' TAVR sales past forecasts, but slowdown predicted

While the delta variant was not directly discussed on the call, CFO Scott Ullem acknowledged "flare-ups of COVID in various regions" but downplayed any impact on the company's business.

By Nick Paul Taylor • July 30, 2021

Patient deaths called 'injury,' 'other' in FDA medical device database: study

The analysis raises questions about the complex reporting system. FDA has reached out to the lead author for reports believed to be misclassified to perform its own evaluation.

By Ricky Zipp • Updated July 30, 2021

Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests

Antigen test revenue grew more than 200% but is now expected to drop significantly. Unlike rivals Abbott and Quidel, which have seen fast-falling sales, the German medtech primarily serves Europe.

By Nick Paul Taylor • July 30, 2021

Supply constraints stymie Smith & Nephew's ortho recovery

Sales of knees and hips by the U.K. medtech underperformed rivals like Stryker and J&J, sending shares down in London. 

By Nick Paul Taylor • July 29, 2021

Talk of Baxter-Hillrom tie-up grows as both companies focus on connected care

Hillrom CEO John Groetelaars in a Friday earnings call highlighted the growing importance of connected care, the focus area of Baxter's current M&A strategy. A Baird analyst said it sounded like a non-specific defense of a deal.

By Nick Paul Taylor • Updated July 30, 2021

As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures

Kevin Lobo said the uncertainty is "baked in" to the company's forecast, though some analysts noted coronavirus variants cloud the outlook for the rest of the year.

By Susan Kelly • July 28, 2021

Mayo Clinic named U.S. News top hospital for sixth straight year

The list, which already examines specialty areas like knee replacements, added seven new measures including care for spinal fusion and hip fracture.

By Shannon Muchmore • July 28, 2021

Boston Scientific tops pre-pandemic results in Q2, expects similar trends in H2

The company joins a handful of other medtechs seeming to move past the crisis, fueled by the return of elective care. CEO Michael Mahoney expects a "manageable level of COVID impact in the second half of the year."

By Ricky Zipp • July 27, 2021

Boston Scientific, Zimmer Q2 expectations lifted by Abbott, J&J, Intuitive results

Second-quarter results from Abbott Laboratories, J&J and Intuitive Surgical offer encouragement for the rest of the medtech reporting season, according to BofA Securities analysts. They also expect a "small beat" for Dexcom. 

By Nick Paul Taylor • July 26, 2021

Growing cyberattacks on hospitals may soon hit bottom lines, patient care: Fitch

The increased use of smart monitoring devices, telehealth and other virtual care capabilities are putting patient data at risk, the report said. CT scanners and MRI machines were not necessarily designed with "cyber risk in mind."

By Ron Shinkman • July 26, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

FDA labels Philips sleep apnea, ventilator recall Class I, ResMed eyes advantage

The agency notices come about one month after Philips announced the recall and began pulling machines from the market. Rival ResMed said there has been a "considerable increase in demand" for its products since the recall.

By Ricky Zipp • Updated July 23, 2021

CDRH still digging out of backlog caused by COVID-19: Shuren

"We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us," the device center chief said. "Hopefully, sometime in 2022 we'll get back on track."

By Ricky Zipp • July 22, 2021

Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics

While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.

By Greg Slabodkin • July 22, 2021

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

By Nick Paul Taylor • July 22, 2021

Intuitive's Q2 robot placements accelerate amid procedure recovery

While the robotic surgery leader is eyeing the delta variant for potential to curb demand, the company raised its forecast for procedure growth this year. However, the outlook does not reflect significant disruptions.

By Susan Kelly • July 21, 2021

J&J medical device sales return to pre-pandemic levels in Q2 as COVID-19 impact wanes

The company's return to growth, fueled by the recovery of elective volumes, could signal where procedure-dependent medtechs stand as the industry recovers from the effects of the coronavirus.

By Ricky Zipp • July 21, 2021

Radiation therapy 'under attack' from CMS cuts, professional body warns

Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

By Nick Paul Taylor • July 21, 2021

Medtech funding surges with early-stage deals

Robot company CMR Surgical, portable dialysis system maker Quanta Dialysis Technologies and diabetes technology developers were among the biggest recipients of private financing in the second quarter.

By Susan Kelly • July 20, 2021

CMS pitches stiffening price transparency fines, halting end of inpatient-only list

The proposed rule moves hundreds of procedures back to hospitals and reverses a Trump-era regulation that attempted to phase out the inpatient-only list. An ASC representative called the regulatory back-and-forth "jarring."

By Shannon Muchmore • July 20, 2021

Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target

The agency's OK for the spinal cord stimulation device potentially opens a market worth billions of dollars. For now, though, preliminary quarterly revenue came in below its prior forecast.

By Nick Paul Taylor • July 20, 2021

Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers

Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.

By Nick Paul Taylor • July 19, 2021