NESTcc seeks feedback on active postmarket medical device surveillance system

The National Evaluation System for health Technology plans to work with a contractor to test real world scenarios for devices such as ventilators, robotic surgery, breast implants and fully disposable duodenoscopes.

By Nick Paul Taylor • Aug. 13, 2021

Medtech industry starts to face lack of diversity, execs of color

AdvaMed contends the percentage of Black people in leadership roles at device companies has more than doubled from 1.3% to 3.2% since 2015. However, currently none of the largest medtechs has a CEO of color.

By Greg Slabodkin • Aug. 12, 2021

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Study reveals stroke risk that brought down Medtronic's HeartWare HVAD

Registry data shows that the pump had a higher rate of stroke than Abbott's HeartMate 3. The study comes weeks after Medtronic pulled the device from the market in response to neurological adverse events. 

By Nick Paul Taylor • Aug. 12, 2021

Should healthcare organizations pay to settle a ransomware attack? Experts weigh in at HIMSS21

"I don't think there's a single yes or no," said Michael Coates, former chief information security officer for Twitter.

By Rebecca Pifer Parduhn • Aug. 11, 2021

Boston Scientific gets FDA nod for single-use bronchoscope, sees $2B opportunity

The medtech giant is targeting a potentially lucrative market but will face competition from rivals with a longer history in the space, including Ambu and Olympus. A limited U.S. release of the device is set for the coming weeks. 

By Nick Paul Taylor • Aug. 11, 2021

'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

By Nick Paul Taylor • Aug. 11, 2021

Philip Morris buys developer of inhaled heart attack drug, ramping up push into healthcare

News of the takeover comes weeks after the tobacco company bought an oral drug delivery specialist and entered into a bidding war to buy inhaled medicine player Vectura. Health charities have pushed back against Philip Morris' foray.

By Nick Paul Taylor • Aug. 10, 2021

Diabetes tech companies set sights on Type 2 patients as user numbers climb

With patients flocking to CGMs and insulin pumps over the past several years, companies like Dexcom, Insulet and Tandem are looking to further expand. 

By Ricky Zipp • Aug. 9, 2021

New digital health solution helps mass COVID-19 testing to prevent Delta variant resurgence

To sustain reopened activities, identify outbreaks and new variants, the ability to manage testing at pace and scale has never been more urgent.

By Piers Ford • Aug. 9, 2021

FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line

The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.

By Nick Paul Taylor • Aug. 9, 2021

Medtronic to buy Intersect ENT in $1.1B deal targeting chronic rhinosinusitis market

Intersect ENT's implants, which deliver steroids to open sinus passageways, could position Medtronic to sell products for a condition affecting 35 million U.S. adults. 

By Greg Slabodkin • Aug. 6, 2021

ResMed reaffirms Philips recall is up to $350M boost but held back by supply chain struggles

"Supply bottlenecks continue to restrict our access to critical electronic components, especially semiconductor chips, that ultimately limit our net production output,” CEO Mick Farrell told investors late Thursday.

By Nick Paul Taylor • Updated Oct. 29, 2021

iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.'

Amid a challenging 2021, the cardiac monitoring player beat Wall Street revenue expectations. However, Medicare pricing uncertainty is still hanging over its future.

By Ricky Zipp • Aug. 6, 2021

BD results called mixed amid bullish COVID-19 testing outlook

The medtech assumes no major system-wide hospital restrictions on electives, despite the rapid spread of the delta variant, raising eyebrows from one analyst group. BD also announced CFO Chris Reidy will retire.

By Greg Slabodkin • Aug. 5, 2021

Nevro shares plunge 25% after sluggish Q2, execs brace for worse to come

Struggles in the second quarter led analysts to question whether the company is losing share to rivals such as Abbott Laboratories, Boston Scientific and Medtronic. Nevro refuted the idea that it's losing market share.

By Nick Paul Taylor • Aug. 5, 2021

Outpatient revenue drives hospital volume rebound in June, Kaufman Hall says

The report's year-to-date trends in outpatient visit growth add to color from medtech companies reporting electives rebounding in recent financial results.

By Hailey Mensik • Aug. 4, 2021

Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel

One expert said there's "compelling evidence that [Keystone Heart] not only didn't demonstrate efficacy, but there's a potential signal of harm."

By Nick Paul Taylor • Aug. 4, 2021

Philips ventilator recall labeled Class I by FDA, second in as many weeks

The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices.

By Nick Paul Taylor • Aug. 4, 2021

Roundup: Medtechs mirror pre-pandemic results in Q2 fueled by procedure volume recovery

After elective procedures began gradually rebounding in the first quarter of 2021, companies are reporting results close to or beating 2019 levels.

Aug. 3, 2021

Zimmer beats Q2 expectations, pandemic still a drag on large joint procedures

As the delta variant causes COVID-19 surges across the globe, CEO Bryan Hanson said on a Tuesday earnings call "it doesn't seem to be translating into the same revenue disruptions we've seen in the past."

By Susan Kelly • Aug. 3, 2021

Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic

Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022.

By Nick Paul Taylor • Aug. 3, 2021

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

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