Medical Devices

BD's FDA filing to update recalled Alaris pumps delayed by 6 months

The medtech planned to rectify the situation with FDA this year, but that schedule has slipped as it continues system testing and ongoing discussions with the agency. BD estimates remediation costs will total $200 million.

By Greg Slabodkin • Aug. 10, 2020

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

The 16 notified bodies now allowed to complete work under the Medical Device Regulation and the four OK'd under its In Vitro Diagnostic counterpart together meet the goal that authorities had hoped to achieve by the start of 2020.

By Nick Paul Taylor • Aug. 10, 2020

Healthcare gains jobs in July, but still down 800K from February

The latest report shows ambulatory, outpatient, and medical and diagnostic lab service jobs are creeping closer to last year's levels.

By Hailey Mensik • Aug. 07, 2020

Insulet tops Q2 forecasts, as diabetes tech resilient in wake of coronavirus

The number of new insulin pump users was halved in the quarter as COVID-19 reduced typical patient-doctor interactions, but the company kept its $1 billion revenue target for next year.

By Maria Rachal • Aug. 07, 2020

Acutus raises $159M in IPO, challenging medtech leaders for cardiac mapping market

The arrhythmia management company's transition is part of its strategy to crack a market already being fought over by medtech giants Abbott, Boston Scientific, Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Aug. 07, 2020

BD sales slide below expectations, as COVID-19 antigen test gains momentum

In the month since the launch of its antigen test, CEO Tom Polen said BD shipped more Veritor readers than in a typical year. Still, the medtech's stock fell 9% Thursday amid pressure on other business lines.

By Greg Slabodkin • Aug. 06, 2020

Nevro blasts past analyst consensus on rebound in pain procedures

The spinal cord stimulation device maker contends it picked up market share from rivals such as Abbott, Boston Scientific and Medtronic amid the pandemic.

By Nick Paul Taylor • Aug. 06, 2020

ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing

"While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter," said CEO Mick Farrell.

By Greg Slabodkin • Aug. 05, 2020

NuVasive's spine robot sees delay, again

Amid COVID-19 constraints, the Pulse application may not be used in humans until 2022 in a spinal robotics market some analysts call significantly untapped.

By Maria Rachal • Aug. 05, 2020

Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year's end

Like rival Stryker, new placements of the company's robot-assisted knee replacement systems had traction during a second quarter when deferral of elective procedures took away over a third of its typical total revenue.

By Maria Rachal • Aug. 04, 2020

Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

After leading the sacral neuromodulation market for two decades, Medtronic is defending its turf with FDA approval of a product it contends is 80% smaller than its current device and 50% smaller than Axonics' rechargeable system.

By Susan Kelly • Aug. 04, 2020

CMS proposes eliminating inpatient-only list, in potential boon for ASCs

The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

By Shannon Muchmore • Aug. 04, 2020

Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

By Maria Rachal • Aug. 03, 2020

House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

By Susan Kelly • UPDATED: Aug. 7, 2020 at 11:06 a.m.

Varian sold to Siemens Healthineers in $16.4B all-cash deal

Breaking with a trend of smaller medtech deal values in 2020, the pact will see radiation oncology equipment and software maker Varian Medical Systems operate as an independent company under Siemens Healthineers.

By Maria Rachal • UPDATED: Aug. 3, 2020 at 9:54 a.m.

Stryker sales slump 24% on elective surgery hits, but Mako robot demand a 'pleasant surprise'

Looking to the third quarter, "we expect the recovery to continue, but do not expect it to be linear, while local governments deal with varying degrees of resurgences," CEO Kevin Lobo said on an earnings call Thursday. 

By Maria Rachal • July 31, 2020

J&J gets FDA breakthrough status for robot-assisted ablation device

The designation gives the product, which combines technologies Johnson & Johnson acquired via takeovers of NeuWave Medical and Auris Health, more regulatory support and potentially speedier review.

By Nick Paul Taylor • July 31, 2020

Teleflex reports rapid rebound in UroLift sales, driving Q2 beat

The medical device maker also disclosed an unspecified number of job cuts and a DOJ investigation during its earnings call Thursday.

By Nick Paul Taylor • July 30, 2020

Baxter takes $180M revenue hit in thick of COVID-19

While acute therapies saw over 40% growth during the quarter, sales in Baxter's advanced surgery, medication delivery and pharma businesses were hurt by lower rates of hospital admissions and elective surgeries.

By Greg Slabodkin • July 30, 2020

Falling FDA personnel costs soften 2021 medical device user fee hike

The agency's required user fees for medical device submissions will rise 7.2% beginning in October.

By Nick Paul Taylor • July 30, 2020

Dexcom nixes plan to begin G7 launch this year

After growing revenues 35% in Q2, the diabetes tech company is focused on building out manufacturing for its continuous glucose monitoring systems and re-emphasizing its direct-to-consumer advertising.

By Maria Rachal • July 29, 2020

Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever'

Organic revenue was down 29% during the quarter but beat analyst estimates, thanks in part to new patients in the pipeline and procedures performed in outpatient settings.

By Maria Rachal • July 29, 2020

FDA finalizes guidance on multiple-function devices after industry feedback

The agency clarified its policies and regulatory practices governing devices that have at least one distinct function and one other purpose that is not subject to premarket review.

By Susan Kelly • July 29, 2020

Smith & Nephew falls short of expectations, citing COVID-19 headwinds

The medtech's sales slumped in the second quarter, causing first-half trading profit to miss analyst consensus by $53 million. Though CEO Roland Diggelmann called July a "good" month, he opted against sharing guidance.

By Nick Paul Taylor • July 29, 2020

Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic

Surgeons expect a gradual recovery of robot-assisted procedure volumes in the back half of the year, but the outlook for new robot system placements in hospitals is less optimistic due to freezes in capital equipment budgets.

By Susan Kelly • July 28, 2020